<![CDATA[The Steely Group: jobboards]]> http://JOBS.THESTEELYGROUP.COM/ en-us <![CDATA[Director, Program Team Lead]]> Our client is seeking a Director, Program Team Lead. The right candidate will possess an in-depth understanding of the drug development process, and have experience ranging from manufacturing to product development and successful product commercialization. As a Program Leader, responsibilities and experience include leading cross functional program teams to develop and execute on drug development plans to register and commercialize drug candidates for rare diseases. The Program Team Leader is expected to develop the long-term plan for the program, contemplating regulatory and commercial expansion well beyond the path to initial approval. The position reports into the Senior Director of Program Management.

Job  Responsibilities:
  • Operational leader for one or more of current clinical development programs
  • Serve as visible program champion and focal point for critical program information
  • Develop an integrated, cross functional, multi-year plan for the program that contemplates both fast paths to initial approval and commercialization and also incorporates medium and long-term opportunities beyond the obvious first path
  • Lead cross-functional program teams to develop strategies and execute on lifecycle management plans to ensure R&D objectives are aligned with overall business strategies
  • Manage and deliver product integrated development plans and ensure alignment across strategic, operational and tactical plans
  • Drive decision making and associated deliverables across all functions of the team and contribute to the portfolio planning process on behalf of the program(s)
  • Establish and maintain integrated cross-project plans to enable accurate project, financial and portfolio analyses
  • Ensure accurate project, financial, and portfolio analyses are provided for planning processes and resource allocation
  • Manage financial budgeting and forecasting process, including long range planning and budget drivers
  • Perform full program planning, goal setting, and execution within team environment


Qualifications:
  • 10+ year of industry experience with 5+ years of leading and managing preclinical and clinical drug development programs
  • Bachelor’ s degree in life sciences with an advanced degree (MBA, MPH, MS, PhD, etc.)
  • Understanding of late-stage clinical development and pre-commercialization activities required
  • Drug development and approval process  experience with advanced knowledge of FDA, EMA and ICH regulations, industry standards and quality control principles
  • Experience with Compassionate Use Programs, Investigator Sponsored Trials, and transition of clinical programs to commercialization highly preferred 
  • Must be proficient in Microsoft Project, Word, Excel, PowerPoint, and Adobe Acrobat

 
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Wed, 18 Oct 2017 00:00:00 EDT 0
<![CDATA[eTMF Specialist]]> Our client is seeking an eTMF specialist. This individual will be integral to performing quality control reviews of several study eTMFs, updating metadata as necessary, and tracking and querying missing/erroneous documentation to ensure that eTMFs are complete and exceed our internal standards and regulatory requirements.

Job  Responsibilities:
  • Conduct Quality Control (QC) review of clinical study documentation in the eTMF to assess adequacy of documentation, accuracy of filing based on TMF table of contents, consistency with naming conventions, and completeness of metadata.
  • Generate prompt QC status reports and communicate the results to the study team leads.
  • Ensure timely resolution of QC findings and track progress.
  • Ensure eTMF structures are in compliance with regulatory guidance, internal standards, and will ensure rapid retrieval of documents during regulatory inspections.
  • May provide input on the revision of TMF-related SOPs, WIs, and internal TMF-related tools.


Qualifications/Requirements:
  • Minimum of 3 years industry experience in supporting the operations of clinical studies, including duties related to records management and maintenance of TMF/eTMF (eTMF experience preferred)
  • Good working knowledge of FDA GCP, MHRA, and ICH regulations, guidelines, and standards governing regulated clinical research and good documentation practices.
  • Familiarity with the DIA TMF reference model
  • Thorough understanding of Essential Documentation
  • Prior experience with TrialInteractive eTMF is a plus
  • Ability to execute independently and follow-through to completion
  • Independently motivated and detail-oriented with good problem solving ability
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Wed, 18 Oct 2017 00:00:00 EDT 0
<![CDATA[Sr. Associate, Regulatory Operations]]> Our client is searching for a creative, resourceful, integrative thinker for a role responsible for all aspects of Regulatory Operations including submission project management. 

Job  Responsibilities:
  • Publication and submission of electronic submissions (and paper submissions, when required) to regulatory agencies to support the conduct of clinical trials and marketing authorizations, primarily for the U.S.
  • Create and maintain archives of communications with Health Authorities.
  • Contribute to the writing, review, and implementation of standards, templates, and procedures related to the publishing, review, transmittal, and archiving of electronic regulatory documentation; recommend and help implement associated process improvements.
  • Support regulatory documentation users and contributors.
  • Leads assigned projects with manageable risks and resource requirements
  • Interprets, implements, and ensures compliance with relevant revised and new FDA/ICH regulations.
  • Acts as submissions representative on local and global project teams; provides resource and timeline estimates for regulatory submissions, as well as technical submissions expertise, as needed.
  • Develops and maintains best practices for the Submissions Group consistent with evolving FDA guidelines for electronic submissions.
  • Provides support to Regulatory Affairs and other project stakeholders in the creation of submissions documents.
  • Position has direct impact on the company' s ability to meet goals and timelines related to regulatory submissions. Identifies and escalates issues which may impact submission timelines and goals.
  • Assists the regulatory affairs liaisons in the determination of submission strategy.


Qualifications/  Requirements:

Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.  Excellent interpersonal skills, ability to develop important relationships with key stakeholders, excellent analytical skills and an ability to communicate issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
  • BA/BS degree or equivalent experience
  • Experience in Regulatory Operations in a biotech/pharmaceutical industry is a plus, open to junior level candidates
  • Extensive experience with Microsoft Word, Adobe Acrobat, and electronic publishing software Experience with Starting Point templates preferred
  • Experience using electronic document management systems.
  • Thorough current knowledge of CTD/eCTD format and regulatory submission requirements
  • Experience compiling IND, NDA, and other CTD submissions
  • Experience in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally preferred
  • Strong attention to detail and the ability to manage multiple tasks
  • Attention to detail and the ability to work independently, within a multi-disciplinary team, as well as with external partners and vendors.
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Wed, 18 Oct 2017 00:00:00 EDT 0
<![CDATA[Clinical Pharmacologist]]> Clinical Pharmacologist

The Clinical Pharmacology Department is searching for a contractor experienced in leading clinical pharmacology program and applying quantitative pharmacology.

Job  Responsibilities:
  • Represent clinical pharmacology at project team by designing and executing clinical pharmacology program including the application of innovative modeling approaches.
  • Apply dose optimization strategy, investigate influence of intrinsic and extrinsic factors on PK/PD, & drug-drug interactions.
  • Apply quantitative pharmacology approach by integrating biology, pharmacology, toxicology, biomarker in support of dose selection & communicate findings to project teams.
  • Collaborate with external network in the field of clinical pharmacology, modeling & simulation (e.g. academia, consortia & CROs) and keep up to date with emerging literature and science in clinical pharmacology and pharmacometrics.


Qualifications/ Requirements:
  • Individual with a PharmD or Ph.D. degree in Pharmaceutical Sciences related fields
  • Understanding of drug development and pharmaceutical industrial.
  • Effective communication skills and the ability to influence, negotiate, and communicate with project team.
  • Minimum of 5 years of pharmaceutical industrial experiences representing clinical pharmacology on project team.

Preferred qualifications:
  • Publication record with clinical pharmacology journals or modeling.
  • Hands-on experience in modeling software such as Phoenix, GastroPlus, SAS, or R is a plus
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Tue, 17 Oct 2017 00:00:00 EDT 0
<![CDATA[Program Manager]]> Our client is seeking a Program Manager who is an innovative, independent and highly motivated Program Manager to support and drive the clinical portfolio. The Program and Portfolio Management team is a highly collaborative one and the position will provide an opportunity to be exposed to and have great cross-functional visibility and great growth opportunities.

Job  Responsibilities:
  • Provide broad program management support for 1 or 2 highly selective, molecularly targeted kinase inhibitors currently in clinical development or approaching IND submission
  • Work closely with the Program Team Leader to organize team meetings by developing agendas, capturing meeting minutes, tracking and following up on action items
  • Work with the project/program lead to facilitate decision making and resolve conflicts;
  • Highlight areas of risk and developing mitigation plans
  • Build and maintain program timelines and dashboards. Track activities and deliverables against strategic plan
  • Anticipate program needs, align program goals and timelines, and liaise cross-functionally with the following groups internally: clinical development, regulatory, discovery, non-clinical toxicology, manufacturing and commercial
  • Act as PM representative on a number of functional subteams. Make sure PTL is apprised of current status and issues as they arise
  • Work with the Program Team Leader to facilitate decision making and resolve conflicts
  • Help to implement SharePoint sites and improve program management tools
  • Communicate program status and issues through key documents (monthly reports, timelines, minutes, etc.) to ensure accurate information is available to the broader organization to enable pipeline and milestone decisions.
  • Collaborates with Finance and other functional leads to align program activities with budget forecast and promote budgetary accountability


Qualifications/ Requirements:
  • A Bachelor’ s degree in a relevant field; advanced degree preferred
  • At least 3 years of experience in a program management role is required, program management experience for clinical-stage programs is preferred
  • NDA experience
  • Biotech and/or pharmaceutical industry experience is highly preferred
  • Preference will be given to candidates with a proven track record of program leadership who have worked in small companies with highly matrixed  environments, and those who have managed multiple programs simultaneously

 
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Tue, 17 Oct 2017 00:00:00 EDT 0
<![CDATA[Pharmacovigilance Operations Manager]]> Our client is looking for an experienced Manager of PV Operations (Mgr PVOps). This new team member will play a key role in optimizing drug safety operations across various PV areas: clinical development, non-interventional studies and post-approval drug surveillance. DS PV works with CROs and global business partners which makes for diverse and complex PV environment.

The Mgr PV Ops ensures that drug safety operations in clinical development programs, and post marketing are aligned with DS PV policies and procedures, agreements and conventions. The Mgr. PVOps ensures that the PV procedures meet best industry standards of efficiency and compliance. The Mgr. PVOps oversees exchange of safety data between functional groups within the organization as well as between client and its Partners. The Mgr. PVOps is responsible for providing training to all representatives on their safety reporting responsibilities.

The Mgr. PVOps reports to the head of Drug Safety Operations and Systems.

Job  Responsibilities:
  • Take part in the daily management of the DS&PV function
  • Monitor compliance with regulations, PV agreements and internal SOPs
  • Work closely with PV Quality and Compliance to maintain a quality PV system
  • Ensure seamless and compliant Safety Data Exchange with all PV Partners and third parties
  • Ensure adequate AE collection in all clinical development and post approval medical research
  • Oversee or execute quality Adverse Event processes in house
  • Oversee Safety Operations both inhouse and outsourced
  • Represent DS& PV in selected clinical development or medical research project teams
  • Develop and organize AE reporting training for all representatives.


Qualifications/ Requirements:
  • BS in a Life Science degree and/or clinical degree (Pharm. D., RN, RPh.) required
  • Minimum 5 years of hands on experience in Pharmacovigilance operations
  • Strong quality focus, with a good understanding of quality systems
  • Be familiar with AE database systems (preferably Argus)
  • Solid knowledge of FDA, EMA, and ICH safety reporting regulations and GVP guidelines;
  • Experience in SAE case management and development of case queries;
  • Experience with overseeing a call center
  • Excellent communicator, both oral and written. Thrive in teams.
  • Good medical writing skills
  • Be proactive and use a risk based approach in complex processes
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Mon, 16 Oct 2017 00:00:00 EDT 0
<![CDATA[Senior Manager, Clinical Operations and Development]]> My client is seeking a Senior Manager, Clinical Operations and Development. They will oversee clinical development programs (pre-IND through Phase 1-3 clinical trials). This key role will manage, plan, and execute clinical studies, including creating and managing study timelines, budgets, and study management plans.  Additionally, s/he will provide guidance and shared learning with and across teams throughout planning and implementation, as well as ensure clinical operational and development deliverables and timelines are met across the development program(s).  This position will report to the Associate Director of Clinical Operations.

Job Responsibilities:
  • Lead the evaluation, selection and management of Contract Research Organizations (CROs) and other external vendors to ensure successful clinical trial implementation and execution
  • Create, manage, and execute clinical operations programs, including study management, and budget and Gantt timeline creation
  • Liaise with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships
  • Author clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs) and other clinical documents as necessary
  • Co-monitor or monitor studies if needed for the program
  • Develop and ensure execution of activities outlined in various study plans (data management, safety management, and study communication plans)
  • Participate in preparation of regulatory filings (e.g. IND, pre-IND, orphan applications etc.) as needed
  • Partner with CMC/clinical supplies to provide drug supply assumptions and contribute to design and packaging of supplies for clinical trials
  • Manage all aspects of study progress from planning to close-out to assure adherence to intended timelines and achievement of study goals while ensuring quality in accordance with FDA, EMEA, GCP, and ICH guidelines


Qualifications/ Requirements:
  • Master’ s degree preferred in a scientific or healthcare discipline
  • Minimum of 6-8 years in clinical and drug development in the pharmaceutical/biotech industry, at least 3 years of direct study management work preferred
  • Understanding of drug development from pre-IND through NDA
  • Extensive experience managing clinical programs, CROs, budgets, and timelines required
  • Strong working knowledge of MS Project and developing Gantt charts
  • Experience monitoring clinical studies and conducting PSVs, SIVs, IMVs, and COVs required
  • Management of CROs, multiple vendors, and complex protocols
  • Protocol, ICF, and CSR writing experience required
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Fri, 13 Oct 2017 00:00:00 EDT 0
<![CDATA[R&D Program Manager / Sr. Program Manager - Late Stage]]> My client is seeking a talented, motivated, and goal-oriented individual to join a growing Program Management team. The successful applicant will play an important role in supporting drug development teams.  This individual will work closely with internal cross-functional teams to ensure clarity of strategy, to manage specific projects/programs, and to facilitate communication across all parties.   The ideal candidate will have a scientific background and experience with clinical-stage drug development.  This role is highly cross-functional, and may involve close interaction with external partners.

Job  Responsibilities:
  • Serve as project/program manager for one or more drug development teams, providing leadership, coordination, and cross-functional communication to enable teams to meet their goals;
  • Work with team members to compile high-quality, detailed, integrated cross-functional project/program plans, manage project activities, timelines, and resources;
  • Work with the project/program lead to facilitate decision making and resolve conflicts;
  • Work with the project/program lead and project/program team to identify key risks, timeline and resource constraints, and develop mitigation plans;
  • Effectively communicate project/program strategy, status, critical path activity timing, resource requirements, and related issues and/or risks, both internally and to partners, as appropriate;
  • Manage and maintain the team SharePoint site;
  • Effectively lead and manage team meetings by developing agendas, defining and communicating meeting objectives, capturing and disseminating meeting outcomes/information/minutes/action items, and following up on action item; 
  • Facilitate and contribute to the financial planning process, integrating inputs from functions and project/program teams into financial plans in collaboration with the Financial Planning & Analysis partners.
  • Help to create and improve program management tools and best practices.
  • Organize events to recognize team accomplishments.


Qualifications/ Requirements:
  • A 4-year degree and a minimum of 3-5 years of relevant work experience including some project or program management.
  • Late Stage drug development experience. 
  • Able to express ideas and present information clearly and effectively within teams, across functions, and with external partners.
  • Able to effectively lead team meetings and facilitate discussions within the team.
  • Demonstrate active listening and constructive feedback within team.
  • Ability to facilitate problem solving, decision making, and issue resolution.
  • Demonstrated analytical and technology skills, including proficiency in project planning tools, content management tools, and the Microsoft Office Suite.
  • Strong program management and organizing skills: 
  • Communicating across the organization to align on shared goals and responsibilities;
  • Working with teams to clarify vision and direction;
  • Developing work plans to meet goals;
  • Managing multiple projects at the same time;
  • Managing teams to meet goals and deliverables, tracking progress toward plan;
  • Highlighting areas of risk and developing mitigation plans;
  • Identifying options and facilitating decisions to enable projects to move forward;
  • Working with teams to develop budgets, and tracking progress towards plans;
  • Ability to plan and facilitate effective, efficient meetings, and prepare clear meeting minutes.
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Fri, 13 Oct 2017 00:00:00 EDT 0
<![CDATA[Pharmacovigilance Operations Associate (Physician)]]> As a Pharmacovigilance Operations Associate (Physician), you will support the Pharmacovigilance team in reviewing, querying, documenting and reporting on all serious adverse events (SAE) & Suspected Unexpected Serious Adverse Reactions (SUSAR) cases related to clinical studies.

Job Responsibilities:
  • Provide timely and sound medical review of individual case safety reports (ICSR) from clinical trials.
  • Actively participates in the case initiation process (case triage) and case data inputting/data entry as more complete SAE information becomes available.
  • May participate in the case narrative generation, review and refinement process depending upon level of experience.
  • Conducts several rounds of query and response (back to site) to gain complete and accurate case information.
  • Navigates Safety Database including the advancing of cases within the workflow and understanding and conducting of various medical coding applications.
  • Represent department as medical safety lead on cross-functional study and program teams for assigned products and studies, providing expert guidance regarding safety matters and issues.
  • Participate in protocol development, specifically the monitoring and collection of safety information in clinical trial protocols, as well as statistical analysis plans.
  • High Comfort Level in working in Multidisciplinary teams; providing input in team meetings and relaying information to PV management.
  • Participate in the analysis of safety data from on-going and completed clinical trials and representation in Clinical Study Reports.
  • Contribute to preparation and review of periodic reports (DSUR, CSR)
  • Review and provide medical content, as needed, for key study-related documents, e.g. IB, ICF, IDMC Charter.
  • Participate in departmental development activities including Training Staff, SOP and Work Instructions development.
  • Provide guidance to staff regarding optimal practice regarding collection, evaluation and processing of adverse experience reports, from a medical perspective.
  • Participate in the regular review of safety data for assigned products for the identification of new safety signals, in accordance with signal detection practices.
  • Participate in Risk Management Strategy
  • Other activities, as needed or as requested by manager.


Qualifications/ Requirements:
  • Doctor of Medicine or Doctor of Osteopathic Medicine required; equivalent foreign medical graduates may be considered.
  • A minimum of 3 years Drug Safety/Pharmacovigilance experience in a pre-approval setting.
  • Oncology experience required.
  • Experience with Oracle’ s Argus Safety Suite or comparable database required.
  • Strong familiarity of GCP, ICH and Global regulations.
  • Experienced in the evaluation and interpretation of data
  • Ability to multi-task
  • Solid written and oral communication skills.
  • Solid judgment and decision-making skills, including the identification and communication of relevant safety- related issues or concerns to Medical Safety Management in an appropriate and timely manner.
  • Experienced in safety reviews of AEs/SAEs, IBs, protocols, clinical study reports, informed consents, and other safety-related documents.
  • Close attention to detail.
  • Ability to collaborate well with others.
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Fri, 13 Oct 2017 00:00:00 EDT 0
<![CDATA[Pharmacovigilance Operations Lead - (Director/Associate Director)]]> Our client is currently seeking a consultant/contractor to provide supplemental support for a growing Drug Safety Operations function.  The primary responsibilities will to provide functional leadership, management support and mentorship for direct reports functioning in the Operations and Systems/Analytics/Reporting roles.   Additionally, other activities would include of support ongoing DSPV projects such as drafting of SOPs, other process documentation or storyboards, project/alliance management activities in support of clinical trials and/or global periodic reporting.          

This role will provide will provide leadership and managerial responsibility with internal Drug Safety team collaboration for the ongoing process development and management of a growing Drug Safety operations function.  The role requires broad understanding of the interdependencies of Drug Safety Operations with the ability to manage and mentor functional reports in Operations, Analytics and Systems to support end-to-end Drug Safety Operations for investigational and marketed products.  This role requires broad understanding of best practices within Drug Safety and collaboration within DSPV for departmental development refinement and implementation key activities such as SOPs and other process documentation, systems/tools, metrics/KPIs and Dashboards, analytics and reporting, inspection readiness.  

This individual must demonstrate effective direct report management, leadership and collaboration skills with DSPV leadership and cross-functional partners including the ability to ensure appropriate safety reporting capabilities from a Commercial Contact Center.  The successful candidate will demonstrate accountability and sense of urgency in leading/managing projects and direct reports in a complex work environment.  The candidate must have strong written and verbal communication skills and demonstrate a willingness to roll-up their sleeves and assist with work projects as needed.

Job  Responsibilities:
  • Oversee operations input to routine pharmacovigilance activities performed including, but not limited to: AE case processing, US Contact Center related PV activities, safety systems and analytics with an external host vendor, signal detection, global periodic reporting. 
  • Collaborate within DSPV to further refine policies, guidelines, Standard Operating Procedures (SOPs) and Work Instructions (WINs) to adequately cover a quality PV system.
  • Maintain good communications with key stakeholders, including Clinical Operations, Clinical Affairs, Medical Affairs, Regulatory Affairs, Global Quality to share and discuss DSPV-related processes.
  • Participate in or leads relevant cross-functional initiatives or work streams as needed.
  • As a member of the DSPV team, collaborates with the leaders to drive the organizational strategy, goals, and objectives for the department.
  • Educate and coach DSPV colleagues in Operation matters, inspire and promote a spirit of team collaboration and growth internally and externally


Qualifications/ Requirements:
  • Bachelor’ s degree in science with 10 years’ relevant experience of which  5 years’ are US-based.  Global pharmaceutical drug safety equivalent experience in combination with an advanced degree with less experience may be considered.  Health professional degree (PharmD, BSN, RN, MD) is preferred.   
  • Demonstrated knowledge of Drug Safety and pharmacovigilance processes and operations systems with understanding of interdependencies with other functions. Broad knowledge of pharmaceutical compliance practices. 
  • Safety reporting applications: Proficient knowledge of Oracle Argus Safety and related tools.  Knowledge of clinical trial operations/electronic data capture and relationship with Drug Safety
  • Expert knowledge of FDA, GVP, EU safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; knowledge of global safety regulations
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Fri, 13 Oct 2017 00:00:00 EDT 0
<![CDATA[Sr Manager/Manager Drug Safety and Pharmacovigilance Systems]]> The Manager of Drug Safety and Pharmacovigilance (DSPV) Systems is a member of the DSPV core team and is responsible for the use, maintenance and business function operational support of the externally hosted Safety Database (Oracle Argus Safety) and related systems.

In this role, the manager will create custom and ad hoc reports, develop and maintain user guides, training materials user support and SOPs, provide validation coordination and maintain the change control processes with the vendor as well as with internal change management processes.  The manager will need to drive the implementation of further system and analytical tools and reports for enhanced functionality with DSPV as well as cross-functionally. This role will work in close collaboration with DSPV, Quality Assurance Validation and IT, and as the business representative for further projects, define user requirements and acceptance testing as needed. 

Job Responsibilities:
  • Lead the design and implementation of Safety system and/or applications/system tools to sustain Drug Safety objectives, including Argus Safety, MedDRA, Analytics, Mart and Reporting tools, etc.  Coordinates with vendor creation of validation/testing documentation.  Executes as appropriate UAT testing.  Ensure proper storage of related documentation regarding any system update bases upon the initial requirements and any subsequent changes.    
  • Application administrator residing within the DSPV function, responsible for managing the implementation of all change control updates to Argus and related systems/tools.  Maintains configuration baseline documentation as appropriate. 
  • Translates requests for data outputs into programmed output table(s), listings, metrics, KPIs,
  • Create programming, validation methodology for the generation of reports for various data analysis (e.g. adhoc, periodic line listings, etc.).
  • Implement system change controls with external host vendor. 
  • Interpret regulatory guidance changes as they impact technology and provide technology expertise to implement system changes for maintaining compliance.
  • Coordinate medical dictionary version management and upgrades with system host vendor. 
  • Maintain compliance with relevant policies and procedures
  • Provide technology expertise for the definition and implementation of change initiatives aligned with vision and strategies.  Expertise in vendor procurement process (e.g. RFP) for DSPV related projects. 
  • Support the resolution of complex, cross-functional issues using strong problem solving abilities.
  • Inspect and resolve safety database problems quickly and effectively.  Escalate to vendor(s) as appropriate. 


Qualifications/ Requirements:
  • MS in technical field preferred; BS in technical field required
  • Minimum 5 - 7 years of experience within a regulated industry required with experience with validated pharmaceutical/drug safety systems and applications preferred
  • Ability to build and sustain relationships with internal/external partners and vendors
  • High-level understanding of global guidance, best practice and regulations supporting pharmacovigilance for post-marketing and investigative drugs
  • Understanding of MedDRA structure preferred
  • Advanced knowledge of Oracle databases and PLSQL programming
  • Advanced skills in report generation using business intelligence tools (Business Objects, SpotFire, Cognos, etc.)
  • Understanding of database architecture (Argus Safety Database preferred)

Skills/Knowledge Preferred:
  • High level of proficiency with MS Office applications
  • Knowledge of scientific terms and medical terminology
  • Quality orientation: attention to detail, accuracy
  • Understanding of documentation requirements (GxP) in a regulated environment
  • Advanced knowledge of controlled document applications preferred
  • Excellent written and oral communication skills Strong presentation, facilitation, negotiation, collaboration and communication ability.
  • Team player; open minded, creative thinker.  Capable of working effectively under pressure in a multi-cultural environment, at any level of the organization, with a variety of stakeholders
  • Contribute in maintaining an effective, open and supportive environment for the discussion of Drug Safety systems and application opportunities.
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Fri, 13 Oct 2017 00:00:00 EDT 0
<![CDATA[Associate Director, CMC Regulatory Affairs]]> Our client is looking for an Associate Director of CMC Regulatory Affairs to join their growing and dynamic team.  Reporting to the Director of Regulatory Affairs, the Associate Director of CMC Regulatory Affairs will be the leader in interactions with the Regulatory Authorities as necessary to support CMC activities.  The person in this position will guide CMC regulatory strategy to support global development of small molecules and will be responsible for the development of compliant, high quality, CMC related submissions to support early development, registration and life cycle management.

Job Responsibilities:
  • Plan, write and review CMC sections across all pertinent regulatory submissions (i.e. clinical trial and marketing applications, formal meetings, life-cycle management submissions)
  • Develop and execute CMC regulatory strategy for long-term planning including the potential to accommodate expedited development needs
  • Work effectively and provide regulatory expertise to cross-functional teams
  • Review and approve technical documentation in support of CMC and QA activities for small drug molecule programs and to assess regulatory impact for development process changes
  • Engage with Regulatory Authorities on project related matters
  • Provide insight and guidance on implementation of current regulations with respect to the preparation and submission of CMC regulatory documentation as a member of internal Project Teams


Qualifications/Requirements:
  • B.S. in a scientific discipline required (degree in Chemistry strongly preferred); advanced degree a plus
  • Must have 8-10+ years pharmaceutical industry experience in CMC Regulatory Affairs
  • Solid knowledge of: drug development; FDA, EMA and ICH CMC guidelines and regulations; current Good Manufacturing Practices (cGMP)
  • Experience with small molecule drug development is required
  • Previous direct experience with early development programs through registration strongly preferred
  • Excellent organizational and communication skills, both written and verbal
  • Must have previous experience leading interactions with health authorities
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Thu, 12 Oct 2017 00:00:00 EDT 0
<![CDATA[Medical Director]]> The primary job functions for this position are related to pharmacovigilance activities for marketed products in the Immunology Therapeutic Area.

Job Responsibilities:
  • Performing medical review of complex advertising and promotional materials for therapeutic areas. Ensure the accuracy and detailed medical reviews of worldwide commercial advertising and promotional materials.
  • Establishes and maintains cooperative relationships with US and AI counterparts across functional areas (eg, Marketing, Regulatory, Legal, Risk Management, Sales Training, Clinical Teams, and Public Affairs).
  • The Medical Director assumes a leadership role in departmental or cross-functional goals and projects. Develops, implements, and evaluates appropriate work tools and methodologies to enable Global Medical Communications to continually improve processes, performance, and productivity.
  • In an independent manner, critically evaluates literature, interprets complex data, writes effectively, articulates information to a variety of audiences, and effectively negotiates with counterparts from cross-divisional functional areas.
  • Provides cross-functional direction and negotiation of Medical Communication responsibilities and compliance issues.
  • Develops and executes departmental and therapeutic area strategies. Responsible for supporting the division and company’ s strategic direction and goals. Ensures team compliance with regulatory and corporate requirements to avoid audits, warnings, penalties, and sanctions by regulators worldwide.
  • Strong knowledge of clinical trial methodology, statistical concepts, and independent evaluation and interpretation of complex literature. Applies understanding of regulatory and compliance requirements to medical communications, advertising, and promotion.


Qualifications:
  • Bachelor’ s degree from an accredited Nursing, PA, Pharmacy, PhD in Health Sciences, or MD/DO program required.
  • Advanced degree preferred.
  • Minimum requirement of 4 years of combined licensed clinical practice experience, postgraduate training, and/or postgraduate pharmaceutical industry experience.

 
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Thu, 12 Oct 2017 00:00:00 EDT 0
<![CDATA[Sr. Medical Director]]> Job Responsibilities:
  • Provide Medical and Clinical Development expertise and leadership to clinical development programs
  • Design and draft protocol synopses, clinical trial protocols and protocol amendments Provide medical oversight of multiple clinical studies and provide medical input and guidance on scientific, clinical and safety monitoring issues
  • Partner with Clinical Operations and provide leadership and direction to clinical project teams
  • Establish and maintain positive relationships with clinical trial investigators/physicians, KOL’ s and clinical advisors through independent collaborations and scientific meetings
  • Provide strategic input on compounds in development and propose clinical development strategies
  • Provide medical expertise as needed for business development initiatives
  • Provide medical and scientific expertise to preclinical discovery groups for compounds that are in preclinical development 


Qualifications/ Requirements:
  • MD required, subspecialty training in neurology or pediatrics is preferred
  • 5+ years of hands on pharmaceutical or biotech experience in clinical development. Rare/orphan diseases preferred, but not required
  • In depth knowledge of drug development process and oversight of clinical trials
  • Working knowledge of biostatistics, regulatory, clinical pharmacology and pharmacokinetics
  • Excellent interpersonal, written, verbal and visual communication skills
  • Proven ability to successfully manage multiple tasks and prioritize accordingly
  • Professional and pleasant demeanor
  • Willingness to travel

 
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Thu, 12 Oct 2017 00:00:00 EDT 0
<![CDATA[Executive Director, Regulatory Strategy]]> Our client is seeking an Executive Director, Regulatory Strategy. Reporting into the Sr. Vice President, Regulatory Affairs, the Executive Director, Regulatory Strategy is responsible for developing and directing regulatory strategy, objectives, policies and programs pertaining to the development and marketing of assigned products. This role includes the regulatory responsibility to support the US and global registration and life cycle management. The qualified candidate will serve as the US and global regulatory strategy lead for assigned projects.   This is both a strategic and hands-on tactical role within the Global Regulatory Affairs team. 

Job Responsibilities:
  • Responsible for providing innovative and proactive strategic leadership to project teams in early and late stage clinical programs
  • Lead the planning, strategy content and execution of NDA/BLA filings and approval
  • Proactively identify regulatory risks to the strategic and operational/tactical plans and propose options to mitigate risks
  • Prepare and lead the team in negotiations with FDA on assigned products as needed
  • Lead and supervise the planning and preparation (including authoring where appropriate) of routine and complex documents, including INDs, briefing documents, orphan drug designation, fast track and rare pediatric designation as appropriate
  • Provide regulatory due diligence as needed
  • Work closely with Alliance partners to prepare and execute global regulatory development partners
  • Provide client with current and proposed regulatory, scientific and  pertinent legal issues (i.e., external meetings, workshops and conferences).
  • Ensure that all documents to be submitted to regulatory agencies have  been evaluated to assure that they are complete, well organized, scientifically accurate, of high quality, are in regulatory compliance, and are presented in a way that facilitates agency review.
  • Guide project teams to implement appropriate regulatory strategies.
  • May train or mentor junior staff


Qualifications/ Requirements: 
  • 10+ years of pharmaceutical/biotechnology industry experience with technical management experience
  • Minimum of 5 years of experience in US and/or the EU as a Regulatory Lead
  • Proven track record of successfully leading NDA/BLA or MAA submissions
  • Ability to successfully interact with all levels of management
  • Demonstrated knowledge of drug development process in the US and/or the EU is essential. Knowledge of laws and regulations affecting the pharmaceutical industry, and regulatory experience.
  • Must have prior experience working with FDA and/or EMA.
  • Ability to analyze and interpret scientific and technical information, as well as regulatory documents
  • Experience of successful NDA and/or BLA filing essential.
  • B.A./B.S. or higher degree (s) in the sciences, or health related field. Advanced scientific degree preferred
  • Demonstrates personal leadership and be excellent mentors, with a natural ability to bring divergent views together, agree common objectives
  • Experience in gene therapy a plus

 
]]>
Thu, 12 Oct 2017 00:00:00 EDT 0
<![CDATA[Program Lead, R&D, Drug Development]]> My client is seeking a Program Leader who is a creative, resourceful, integrative thinker to oversee two or more high priority neuroscience development programs as they transition from candidate selection into early clinical development.  The ideal candidate will possess demonstrated program experience leading early to late stage drug development programs through launch and life-cycle management in the field of psychiatry and neurology.

The Program Leader will be responsible for leading and managing novel drug development projects and teams to successful development, NDA submission and market introduction.  This individual will work closely with all levels of leadership to determine program strategies and with internal and external groups to resource and implement all aspects of a drug development project. The Program Leader will set strategies and implement operating plans for the organization and be responsible for the overall project budget. The Program Leader will have access to all levels of the Leadership Team and will work closely with all the functional areas to plan, resource, implement and monitor programs.

Job  Responsibilities:
  • Provide effective leadership and direction for drug development programs and lead the Program Team.
  • Serve as Program Leader on one or more Program Teams, providing a model for effective team leadership within a matrix environment.
  • Accountable for meeting targets and managing deliverables.
  • Develop, prioritize, document and communicate measurable annual and long range plans.
  • Work closely with Medical Sciences, Regulatory Affairs, and Commercial to set team strategies through the Program Team.
  • Work with the relevant functions to identity key development and commercialization issues, develop plans to support market introduction, and proactively develop plans to support life-cycle management.
  • Responsible for the management and delivery of an integrated development plan for the compound(s) and ensuring alignment across strategic, operational and tactical plans
  • Drives decision point planning and associated deliverables across all functions of the team Ensures the input from sub-teams to support the advancement of the program’ s objectives and deliverables
  • Assure that management is appraised, in a timely fashion, of the current status and issues surrounding each project.
  • Provide effective solutions for solving Program Team conflicts
  • Manage the program through effective budget planning and accountability, objective setting, performance appraisal and individual development, as appropriate.
  • Review and allocate resources in collaboration with functional areas and program teams
  • Provide sound strategic thinking related to regulatory interactions that lead to successful outcomes; attend key meetings with regulatory agency, as applicable.
  • Define and articulate clear strategic vision within program teams, serving as visible program champion and focal point for critical program information
  • Ability to design and influence new product concepts to R&D and the organization in general
  • Establish and maintain integrated cross-project plans to enable accurate project, financial and portfolio analyses and ensure accurate information is provided for planning processes and resource allocation
  • Manage budget projections and timelines to establish annual goals and to scenario plan across multiple programs in collaboration with cross-functional departments.


Qualifications/Requirements:
  • 15 years’ solid scientific background in pharmaceutical drug development with at least 10  years of experience in a project management function, and 5 years in a team leadership role.
  • Advanced degree in life sciences; a PhD or MBA is a plus
  • Have a past record of achievement in leading and managing project teams and product development with a thorough understanding of the drug development process at a strategic level through the entire lifecycle.
  • This position requires an individual with outstanding organizational and interpersonal skills.  It is essential that this individual can manage relationships and achieve results through influencing others in the organization.
  • Highly developed negotiation skills.
  • Strong knowledge of program budget process and resource allocation.
  • Superior oral and written communication skills are required, as is the ability to function effectively with senior management.
  • A strong focus toward creativity, independent thinking and results orientation is required.
  • Leading programs toward successful NDA/ MAA submissions.
  • Must have high ethical standards and impeccable integrity.
  • Must have highly developed personal leadership style and confidence.
  • Must be able to apply independent thinking, organizational abilities and strong discipline in a dynamic environment.
  • Must have strong detail orientation and be hands-on when needed to do what it takes and achieve key objectives.
  • Ability to understand stakeholder concerns and frame issues/proposals to influence decision making
  • Advanced knowledge of FDA, EMA and ICH regulations, industry standards and quality control principles
  • Capable of managing multiple programs/brands simultaneously
  • Issue Identification and Resolution
  • Cross-Functional Coordination and Communication including senior management
  • Demonstrate and apply understanding of the interdependencies between various stakeholders within the drug development process including but not limited to: medical, science, clinical operations, manufacturing, business, legal & regulatory to accelerate overall drug-development program.
  • Demonstrated technical proficiency, scientific creativity, independent thought and ability to effectively collaborate with others
  • Be a diplomatic professional, ‘ clicking’ easily with the company and leadership, with the foresight and savvy to contribute to the corporate goal of becoming a leader in CNS disorders and bringing medicine to patients.
  • Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
  • Strong team player that has a customer service approach and is solution-oriented.
  • Attention to detail and the ability to work individually, within a multi-disciplinary team in a matrix environment, as well as with external partners and vendors.
]]>
Tue, 10 Oct 2017 00:00:00 EDT 0
<![CDATA[R&D Program Manager / Sr. Program Manager]]> My client is seeking a talented, motivated, and goal-oriented individual to join a growing Program Management team. The successful applicant will play an important role in supporting drug development teams.  This individual will work closely with internal cross-functional teams to ensure clarity of strategy, to manage specific projects/programs, and to facilitate communication across all parties.   The ideal candidate will have experience working with late stage/commercialization projects. An engineering background is preferred but they are open for the right candidate.

This role is highly cross-functional, and may involve close interaction with external partners.

Job  Responsibilities:
  • Serve as project/program manager for one or more drug development teams, providing leadership, coordination, and cross-functional communication to enable teams to meet their goals;
  • Work with team members to compile high-quality, detailed, integrated cross-functional project/program plans, manage project activities, timelines, and resources;
  • Work with the project/program lead to facilitate decision making and resolve conflicts;
  • Work with the project/program lead and project/program team to identify key risks, timeline and resource constraints, and develop mitigation plans;
  • Effectively communicate project/program strategy, status, critical path activity timing, resource requirements, and related issues and/or risks, both internally and to partners, as appropriate;
  • Manage and maintain the team SharePoint site;
  • Effectively lead and manage team meetings by developing agendas, defining and communicating meeting objectives, capturing and disseminating meeting outcomes/information/minutes/action items, and following up on action item; 
  • Facilitate and contribute to the financial planning process, integrating inputs from functions and project/program teams into financial plans in collaboration with the Financial Planning & Analysis partners.
  • Help to create and improve program management tools and best practices.
  • Organize events to recognize team accomplishments.


Qualifications/Requirements:
  • A 4-year degree and a minimum of 3-5 years of relevant work experience including some project or program management.
  • Late stage/commercialization experience
  • Able to effectively lead team meetings and facilitate discussions within the team.
  • Demonstrate active listening and constructive feedback within team.
  • Ability to facilitate problem solving, decision making, and issue resolution.
  • Demonstrated analytical and technology skills, including proficiency in project planning tools, content management tools, and the Microsoft Office Suite.
  • Strong program management and organizing skills: 
  • Communicating across the organization to align on shared goals and responsibilities;
  • Working with teams to clarify vision and direction;
  • Developing work plans to meet goals;
  • Managing multiple projects at the same time;
  • Managing teams to meet goals and deliverables, tracking progress toward plan;
  • Highlighting areas of risk and developing mitigation plans;
  • Identifying options and facilitating decisions to enable projects to move forward;
  • Working with teams to develop budgets, and tracking progress towards plans;
]]>
Tue, 10 Oct 2017 00:00:00 EDT 0
<![CDATA[Associate Manager, Clinical Operations]]> Leads all aspects of a particular clinical study and demonstrates a high level of knowledge of clinical operations’ methodologies, organizational, project management and leadership capabilities

Works to ensure adherence to a standardized approach to project management

Manages clinical trials projects through leadership of and delegation to a cross-functional study execution team (CST), working under the guidance and direction of an Associate Director, Program Lead.  May rely upon Senior Clinical Project Managers for guidance but acts as a mentor/coach to junior staff.

Ensures successful clinical trial planning, execution and delivery – within specified quality, time and cost parameters

Job  Responsibilities:
  • Develops a quality control plan for trial master files and then ensures those TMFs are created, maintained, monitored, and closed out on a timely basis
  • Ensures site monitoring reports are accurate and thorough and that metrics are being adhered to
  • Actively participates in the development of department initiatives, including acting as lead on the development /definition of certain SOPs and processes
  • Ensures that an overarching trial cross-functional quality plan is in place
  • Responsible for managing creation, maintenance and close out of TMF activities – e.g. manages Central Lab and ancillary vendors such as IVRS selection, set-up, conduct, and close-out for studies.
  • Oversees and manages vendors (CRO) to ensure that clinical trials are getting the necessary resources and attention the vendor has committed to ensure trial deliverables and performance goals are met.
  • Oversees the development of and adherence to clinical trial project timelines and ensures senior Clin Ops staff, PDT, and FAHs are informed of and understand risks / challenges, which includes putting risk mitigation plans in place, monitoring risk metrics, and communicating those risks
  • Ensures accurate and comprehensive completion of documents needed by Regulatory Affairs; works with RA to establish timeframes and ensure clarity of documentation required; makes sure that completed documents are handed over to RA within the requested timeframes and ahead of submission deadlines
  • Coordinates the relevant and timely exchange of information / materials (e.g., patient enrollment, site selection, and data collection) with other functions (primarily those represented on CST) to support clinical trials delivery within the drug development process
  • Provides regular timely communications to Supply Operations regarding patient enrollment information at sites to support the supply of drug products to patients
  • Ensures that external partnerships (e.g. CRO) are effectively supporting clinical trials, within contracted terms including budget; is the primary point of contact for CRO partners
  • Adheres to clinical trial budgeting process and provides input on process optimization landscape
  • Leads matrix, multi-disciplinary, cross-functional study execution teams (CST) from start-up through close to ensure both internal and external deliverables are on time and on budget
  • Has both an internal and external perspective on clinical trial management; ensures that clinical trials are operationally feasible while understanding the external landscape, including a focus on KOL activity and the competitive Leads cross functional team to ensure timely activation of clinical trials; including risk management and problem-solving
  • Proactively identifies, negotiates and brokers solutions to individual clinical study issues
  • Delegates and oversees the management of certain aspects of project management to CTA and Senior CTA staff to ensure clinical studies at a project level are executed within specified time, quality and cost parameters.


Qualifications/ Requirements:
  • BA/BS with 5-7 years progressive experience in clinical operations preferably within the biotech, pharmaceutical, CRO, industry
  • Demonstrates ability to provide input into clinical protocol development.
  • Demonstrates ability to manage and execute clinical studies.
  • Demonstrates thorough knowledge and understanding of key regulatory authorities, ICH Guidelines, and GCPs governing the conduct of routine clinical trials.
  • Experience of managing/overseeing CROs/vendors.
  • As a result of being member and project manager of CST, develops detailed understanding of different departments and functions and interdependencies of the functions.
  • Very strong verbal, written and presentation skills are required.
  • Experience of leading of a matrixed cross-functional team.
]]>
Tue, 10 Oct 2017 00:00:00 EDT 0
<![CDATA[Benefits manager]]> Job Responsibilities: 
  • Develop multi-year benefit strategy, which considers competitive market trends, industry comparators and cost effective approaches
  • Provide Management with  recommendations for changes to benefit offerings
  • Provide support & recommendations to support business strategies such as acquisitions and integrations
  • Manage relationships with internal business partners and external vendors
  • Ensure compliance of all programs including timely filings and annual notices, reporting and properly updating any internal communications such as Plan Documents and Summary Plan Descriptions
  • Manage all aspects of the benefits function and make recommendations to drive efficient practices.
  • Responsible for all systems related benefit changes collaboration with the HRIS group
  • Manage the annual open enrollment process


Requirements:
  • Strong organizational skills & follow up protocols
  • Demonstrated “ executive presence” and ability to effectively present to and interact with senior leadership
  • Develop strong knowledge of comparators, market positioning and benefit trends
  • Familiarity with Benefits administration systems
  • Experience in developing and managing relationships with third party vendors
]]>
Fri, 06 Oct 2017 00:00:00 EDT 0
<![CDATA[Physician]]> Seeking a Physician, this part-time, home-based, telehealth role is a great opportunity for a licensed physician who wants to help patients better manage their health through better access and understanding of health information. 

The hired physician will provide telehealth consultative care, including interpreting and explaining laboratory test results to patients. For some clinical situations, the physician will prescribe treatment; in other cases the physician will recommend that the patient seek additional care from a specialist.   The medical conditions diagnosed and treated are limited to non-life threatening conditions or preventive medicine. In addition, this role provides support to the practice in the form of creation of condition specific clinical dossiers, review of medical records, assistance with educating Care Advisors, and other projects as may be determined necessary.

Job Responsibilities:
  • Provides telehealth consultations for patients, including reviewing intake histories and laboratory  test data, and providing interpretations and interventions as required (drug treatment, life style counseling, follow-up testing or referral to specialty care)
  • Participates in peer review  of medical records and practices quality assurance protocols
  • Establishes a trusting rapport with patients 
  • Provides excellent clinical judgement


Qualifications/ Requirements:
  • Current and valid multi-state medical licenses are preferred but not required. A willingness to become licensed in multiple states is required. If the candidate is only licensed in one state, administrative support for additional state licensure will be provided.
  • Previous experience and certification in Internal Medicine or Internal Medicine with Subspecialty Certification in Allergy/Immunology, Infectious Diseases, Preventive Medicine or Rheumatology preferred
  • Board certification preferred
  • Experience treating lifestyle-related disorders preferred
  • No State Licensure Board sanctions or actions on record
  • This is a part-time, home-based position. Minimal travel is required (mainly for initial training at the practice’ s expense)
  • Must be able to work remotely in a quiet, secure, professional environment
  • Favorable references are required
]]>
Mon, 02 Oct 2017 00:00:00 EDT 0
<![CDATA[Associate to the President]]> The Associate to the  President’ s Office  provides high-level, high-quality administrative support to the President and works closely with the Senior Associate to the President to ensure that the President’ s Office runs effectively and efficiently.   In this role, you  must be able to anticipate, take initiative,  adapt to changing priorities, and must demonstrate the ability to be diplomatic, flexible, and discrete with confidential information.

Job Responsibilities:
  • Drafts correspondence for the President.
  • Develops and manages the President’ s Office file management plan and protocols for archiving and data management and improves upon the plan and protocols as needed.
  • Organizes and coordinates complex meetings (e.g., Partnership for Safe and Peaceful Communities and Neighborhood Economic Development Strategy Group).
  • Serves as back-up to the Senior Associate in scheduling calls and appointments with external stakeholders and contacts.
  • Serves as secondary point of contact for incoming calls to the President’ s Office.
  • In coordination with the Senior Associate, creates the administrative budget for the President’ s Office.
  • Manages consultant and vendor contracts.
  • Oversees the Speakers Series, including development of a pipeline of possible speakers.
  • Serves as the primary content creator for President’ s Office events and announcements on the Foundation’ s intranet and back-up content creator for the President’ s posts.
  • Manages grant approval activities for the President’ s Office, including creating quarterly dashboards for the President, entering Letters of Inquiry addressed to the President, and creating PDFs of grant briefs for President-approved administrative grants in the grants management system.
  • Plans for, manages, and creates the quarterly Board book for the Board of Directors.
  • Distributes Board Book and Committee Books, including posting to the Directors’ website.
  • Maintains an updated contact list for the Board of Directors and former Directors.
  • Responsible for procurement of gifts for the Board on special occasions.


Qualifications/Requirements:
  • Bachelor’ s degree or equivalent with at least six to eight years of experience in supporting high-level executives is required.
  • Must be able to execute complex projects with strong attention to detail and to manage multiple projects and tasks and meet deadlines.
  • Exceptional writing and editing skills are essential.
  • Strong organizational skills are essential.
  • Exceptionally strong proficiency in working in Microsoft Office (Word, Excel, PowerPoint, and Outlook), and a strong aptitude for learning new technology and programs is required.
  • Must be able to maintain knowledge on all organizational policies and procedures and stay informed and up-to-date on the activities and achievements of the Foundation.
]]>
Tue, 26 Sep 2017 00:00:00 EDT 0
<![CDATA[Clinical Scientist/Physician Extender]]> The Clinical Research Department is searching for a contract clinical scientist experienced in clinical research.

Job Responsibilities:
  • Assist physicians and working closely with other functions to operationalize trial protocols.
  • Provide scientific support by interpreting safety and efficacy results in clinical trials, including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations.
  • Contribute to the organization, preparation, and execution of investigator and advisory board meetings.
  • Contribute to the authoring and revision of regulatory submissions.
  • Assist physicians to draft manuscripts, review and summarize relevant literature.


Qualifications/ Requirements:
  • An RN, MS, PhD or PA with a minimum of 2 years in clinical research; experience in planning, executing, reporting and publishing clinical studies.
  • Thorough understanding of ICH, GCP, and relevant regulatory requirements, and strong analytical and strategic thinking skills.
  • Effective oral and written communication skills and the ability to influence, negotiate, and communicate with project team.
  • Ability to work collaboratively in a fast-paced, team-based matrix environment.

Preferred qualifications:
  • Prior clinical research experience in these therapeutic areas: GI, endocrinology, metabolic diseases, and CNS.
  • Ability to identify and cultivate relationships with external partners such as clinical investigators, clinicians, scientists, and vendors.
]]>
Mon, 25 Sep 2017 00:00:00 EDT 0
<![CDATA[Clinical Biomarker Scientist]]> The Clinical Pharmacology Department is searching for a scientist experienced in the development and execution of biomarker strategies supporting clinical trials.

Job Responsibilities:
  • Provide biomarker expertise and guidance to program teams to design and implement scientifically driven clinical biomarker plan
  • Serve as single point of contact accountable for executing biomarker strategy, including planning, coordinating, and overseeing all operational activities required to manage the lifecycle of biomarker samples (collection, processing, analysis, data delivery/reporting and final sample disposition)
  • Participate in the authoring of biomarker sections of clinical documents including Clinical Study Protocols, Informed Consent Forms and Laboratory Reference Manuals 
  • Ensure the timely and efficient delivery of all biomarker deliverables, in accordance with the appropriate quality standards and applicable regulations
  • Collaborate with clinical pharmacology and other functions to integrate clinical biomarker data with other data to support dose selection and future trial design
  • Collaborate with internal and external networks in the field of clinical biomarkers and keep up to date with emerging literature and science


Qualifications/Requirements:
  • Individual with a BS, MS, or Ph.D. degree in Biological Sciences or related fields
  • Minimum of 2 years of pharmaceutical industry experience in clinical biomarker plan design and implementation 
  • Understanding of drug discovery and development
  • Effective communication skills and the ability to influence, negotiate, and communicate with the project team

Preferred qualifications:
  • Prior biomarker-related experiences in the following therapeutic areas: GI, inflammatory diseases, metabolic disease, cardiovascular diseases, hematological diseases, or CNS
  • Publication record associated with clinical biomarker investigations
]]>
Mon, 25 Sep 2017 00:00:00 EDT 0
<![CDATA[HR Manager]]> Our client,  a continuing care retirement community, is looking for an HR Manger in their La Jolla Village   facility.  If you’ re someone who has a desire to enhance the lives of others, grow your skills, and develop your career, we encourage you to explore this exceptional  career opportunity.  

Job Responsibilities:  
This selected candidate will be responsible for multiple aspects of the human resources function including but not limited to:
  • Recruitment
  • Compensation and Benefits
  • HRIS
  • Workers’ compensation and employee relations.
  • Implementation of  various programs by partnering with employees at all levels to ensure an educated and effective workforce.


Qualifications/Requirements:
  • Minimum of 5 years of generalist experience in Human Resources; Hospitality or senior living background preferred;  
  • Self-starter with ability to work as part of a team. 
  • Ability to organize and prioritize effectively to ensure timely completion of all responsibilities.  
  • Excellent analytical and deductive reasoning skills, good judgment, problem-solving skills and attention to detail. 
  • Strong oral and written communication and platform speaking skills. 
  • Ability to analyze and manage HR expenses. 
  • Knowledge of federal and state laws, compliance requirements. 
  • Strong interpersonal skills including the ability to manage external resources, (contractors, vendors, agencies, etc).
  • College degree; master’ s degree preferred.
]]>
Thu, 21 Sep 2017 00:00:00 EDT 0
<![CDATA[Health & Wellness Director]]> Directs the Health and Wellness Program. Ensures that company standards and state requirements for resident care are met. Directs staff, ensures regulatory compliance and is responsible for management of clinical budget. This position reports to the Executive Director with DDHW oversight.

Job Responsibilities:
  • Directly oversees the delivery of care to Assisted Living residents to ensure that emotional, physical, psychological and safety needs are met through all program services and activities.
  • Coordinates, along with the Executive Director, and family/resident care conferences and serves as a direct liaison between residents, families, and staff. Works with residents, families and other staff to ensure that residents are at appropriate levels of care.
  • Manages labor costs, supplies and other line items in clinical budget.
  • Monitors documentation systems to ensure that all regulatory timeframes for review of assessments and service plans are met and that resident needs are met. Writes and reviews residents’ assessments/evaluations and care-plans with appropriate staff.
  • Assesses/evaluates potential residents for Assisted Living level of care. This may involve assessing/evaluating potential residents in their home or another healthcare setting; must be able to drive to location and perform assessment/evaluation professionally and timely. Schedules and conducts new resident orientation for all Assisted Living Residents.
  • Plans and schedules staff training programs and in-services for the Assisted Living staff. Attends all required training, in-service, and staff meetings.
  • Manages and coordinates the work of all nursing and other assisted living staff, communicating pertinent resident health and safety information. This includes overseeing and/or completing staff schedules monthly and daily assignments.
  • Strives to maintain a safe working environment through the prevention of accidents, the preservation of equipment, and the achievement of safe working practices.
  • Ensures compliance with all state regulatory requirements including mandatory reporting to State. Ensures that all concern and incident reports are completed, filed and that follow-up is conducted appropriately.
  • Maintains a positive and professional demeanor toward residents, visitors, families, and co-workers while adhering to all policies and procedures.
  • Requires 24/7 on-call clinical support.
  • Performs other duties as assigned.


Qualifications/ Requirements:
  • An Associate' s Degree from a four-year college or university; or one to two years related experience and/or training; or equivalent combination of education and experience.
  • LPN/LVN or RN license.
  • CPR Certification required.
]]>
Thu, 21 Sep 2017 00:00:00 EDT 0
<![CDATA[Payroll Administrator]]> Job Responsibilities:
  • Running weekly Payroll for 1700 employees
  • Both Union and Non union
  • Issuing Paychecks
  • Manage Direct Deposit
  • Experience with running payroll in Canada


Qualifications/Requirements:
  • 3-5 years of payroll experience
  • Experience with Ceridian a plus
  • Fast paced environment
]]>
Tue, 19 Sep 2017 00:00:00 EDT 0
<![CDATA[Director, Quality Assurance]]> With an in-depth knowledge of the Quality System Regulations and FDA requirements, provides leadership for the Quality Assurance department and the company. Develops the quality strategy and ensures that the strategy integrates with other types of risks. Leadership role that requires sound judgment and the ability to assess the likelihood and impact of Quality risks for the company. Establishes relationships with key external vendors and Quality leaders and serves as the Subject Matter Expert for the company in the area of Quality and Validation.

Job Responsibilities:
  • Develop and implement the Quality Compliance Strategy with both senior leadership and business functions within the company. Translate the strategy and vision into goals, objectives and measures for the organization.
  • Assure adherence of QA requirements of the company Quality System Manual. Maintain procedures and policies; ensure that QA maintains compliance with changes to the company Quality System Manual.
  • Partner with company Leadership to conduct Quality Management Reviews and institute enterprise management controls to assess and manage risk.
  • Create a culture of enterprise risk management, education and skill development to operationalize effective risk management processes and practices.
  • Provide overall direction and leadership for the QA organization with robust talent and organization development plans. Provide the coaching, mentoring and leadership to transform the staff from subject matter experts to a cohesive, integrated team of consulting experts.
  • Provide strong leadership in establishing, maintaining, and meeting budgetary requirements.
  • Develop and manage the relationships with key company internal and external Quality leaders. Serve as the Quality Champion in the organization, building awareness and understanding of quality and compliance requirements. Drive a positive cultural change and clear employee accountability for quality and compliance.
  • Remain current with regulatory changes, best practices and new trends in the industry and their impact upon the company bringing appropriate thought leadership to QA in alternative methods to meet the regulations.
  • Form and lead sub-teams comprised of individuals from the company’ s various functions and strategic vendors to address a specific business goal, risk, or solution.

Managerial Responsibilities:
  • Responsible for the strategic development of the department.
  • Define departmental platform policies and guidelines.
  • Ensure development of departmental team.
  • Oversee departmental staff and hold responsibility for performance management, for recruitment/ retention of personnel, and for expense approval and budgeting.
  • Supervise staff and consultants, as needed. Direct resource planning, budgeting, and restructuring to meet project and organizational/corporate needs.
  • Serve on pertinent internal committees.
  • Provide an atmosphere which is conducive to teamwork.
  • Identify need for, creates, and reviews department Standard Operating Procedures (SOPs).
  • Collaborate with Operations and Business Development personnel to finalize project budgets and scope of work; assists with RFP / RFI completion.


Qualifications/ Requirements:
  • Bachelor' s degree in a Science discipline or a related field preferred or relevant systems experience. A Master’ s degree is highly desirable but not required.
  • Must have 10+years of relevant experience including interfacing with outside regulatory agencies. Experience must include leadership and a mix of significant quality knowledge and regulatory compliance responsibility. Past experience in Healthcare sector is expected.
  • Ability to develop a deep understanding of the company’ s business strategy, quality, and compliance requirements and existing quality systems environment.
  • Track record of execution on large scale programs that meet quality, time, and budget requirements.
  • Proven experience in managing staff who administer quality systems, including document control, training, supplier qualification, internal audit, nonconformance, CAPA, reporting metrics, leading Management Reviews, and validation services.
  • Understanding of Quality Management System standards and best practices such as 21 CFR (GCP, GLP, GMP), ICH, ISO, Six Sigma, Kaizen, ANSI.
  • Proven track record of sound judgment including abstract thinking and a good balance between an academic and pragmatic approach.
  • Excellent communication skills with being able to formulate vision and translate vision into execution with measurable results.
  • Strong people skills, ability to work with stakeholders inside and outside of the company, able to mentor team members, build and lead teams with diverse backgrounds.
  • Must be convincing champion for change to build quality and compliance culture across the organization. 
  • Effective negotiation and interpersonal communication skills to interact with a variety of peers and constituents.
]]>
Fri, 08 Sep 2017 00:00:00 EDT 0
<![CDATA[Executive Assistant]]> The Executive Assistant provides a wide range of high level administrative support to the Executive Vice President, Technical Operations, Vice President, Quality Operations, and their staff with general direction and instruction.  This role requires independent judgment, strong initiative, and the ability to effectively prioritize and handle a diversified workload and complex projects in a confidential and sensitive manner.

Job Responsibilities:
  • Performs a wide variety of administrative duties for department leadership including, but not limited to, maintaining calendars, managing telephone calls, completing expense reports, booking domestic and international travel, as well as preparing routine correspondence, interoffice memoranda, etc.
  • Prepares and creates presentations accurately for multiple managers to effectively communicate information/data.
  • Sets up and maintains department administrative files.
  • Effectively creates and compiles reports/information on department deliverables.
  • Makes timely arrangements for department meetings, video and conference calls to include booking rooms, arranging for meals, assuring AV and meeting supply needs are met, taking meeting minutes, and coordinating all meeting planning with appropriate internal and external parties.
  • Performs photocopying, scanning and faxing as required.
  • Assists in managing and monitoring the department office supply budget including ordering and processing purchase orders, invoices and check requests in coordination with appropriate internal departments.
  • Assists with special projects as required.
  • May provide coverage for other administrative assistants in the company as needed.


Qualifications/ Requirements:
  • High School Diploma or GED required
  • 7+ years of administrative experience supporting one or more individuals in a corporate environment required
  • 5+ years prior executive assistant level experience required
  • Advanced proficiency in Microsoft Office suite
  • Strong organizational and interpersonal skills
  • Professional, proactive demeanor
  • Excellent written and verbal communication skills

Essential Core Competencies:
  • Action Oriented
  • Problem Solving
  • Organization
  • Functional/Technical Skills
  • Priority Setting
  • Drive for Results
  • Strategic Agility
  • Intellectual Horsepower
  • Dealing with Ambiguity

Essential Behaviors:
  • Integrity and Trust
  • Composure
  • Standing Alone
]]>
Fri, 08 Sep 2017 00:00:00 EDT 0
<![CDATA[Workers Compensation Specialist]]> The Workers' Compensation Claim Specialist position is to assist the Director of Workers’ Compensation to monitor, and manage workers' compensation claims. This position requires expertise in evaluating of each claim in accordance with the Illinois Workers Compensation Act. This includes, but is not limited to, the claims management process, adherence to all HR policies and work related issues of associate safety and injury prevention.

Job Responsibilities: 
  • Accurate and timely preparation of workers' compensation claims for third party administrator (TPA) which includes, but is not limited to, gathering investigative, medical, employment information for any employee injury or occupational disease.
  • Accurate and timely documentation of all relevant activities and medical information in database.
  • Management and approval of appropriate diagnostic testing and treatment, including surgery as indicated.
  • Coordination of medical case management with external nurse case managers and third party administrator adjusters.
  • Coordinates this information with human resource staff and standardization of the process throughout organization.
  • Provides direction to site management and leaders regarding workers compensation claim issues.


Qualifications/ Requirements:
  • Bachelor’ s Degree or equivalent
  • 5+ experience with Illinois workers compensation claims management
  • 5+ years of related experience in human resources, risk management or related field. (10 years total)
  • Computer literate: Must be able to use Word and Excel
  • Excellent communication skills, both oral and written
  • Excellent organizational skills and time management skills
]]>
Thu, 07 Sep 2017 00:00:00 EDT 0
<![CDATA[Administrative Assistant]]> The Administrative Assistant provides a wide range of high level administrative support to the department.  This role requires independent judgment, strong initiative, and the ability to effectively prioritize and handle a diversified workload and complex projects in a confidential and sensitive manner.

Job Responsibilities:
  • Performs a wide variety of administrative duties for department leadership including, but not limited to, maintaining calendars, completing expense reports, booking travel, as well as assisting with routine correspondence
  • Owns coordination of Sales training including planning new hire flights, hotels, meeting space, and meals
  • Ensures that key documents are current and accurate including state license files
  • Performs photocopying, scanning and faxing as required.
  • Assists in managing and monitoring the department office supply budget including ordering and processing purchase orders, invoices and check requests in coordination with appropriate internal departments
  • Assists with special projects as required
  • May provide coverage for other administrative assistants as needed


Qualifications/ Requirements:
  • High School Diploma or GED.
  • Advanced proficiency in Microsoft Office suite
  • Strong organizational and interpersonal skills
  • Professional, proactive demeanor
  • Excellent written and verbal communication skills

Essential Core Competencies:
  • Action Oriented
  • Problem Solving
  • Organization
  • Functional/Technical Skills
  • Priority Setting
  • Drive for Results
  • Strategic Agility
  • Intellectual Horsepower
  • Dealing with Ambiguity

Essential Behaviors:
  • Integrity and Trust
  • Composure
  • Standing Alone
]]>
Wed, 06 Sep 2017 00:00:00 EDT 0
<![CDATA[Principal Medical Writer]]> The Principal Medical Writer is responsible for providing clinical regulatory document support and advanced scientific writing expertise to the clinical teams, ensuring successful preparation of high quality submission-ready documents and effective implementation of the writing process. Provides medical writing expertise for multiple compounds and/or projects within a therapeutic area. Interfaces with external groups (eg. PK, Toxicology, eSubmissions, Regulatory, Statistical Support, Data Management, Clinical, Publishing) to ensure accurate and timely completion/delivery of information and review of clinical regulatory submissions. Serves as the scientific writing content expert for the department.

Job Responsibilities:
  • Implements all activities related to the preparation and compilation of data and information into a single comprehensive package for new and updated clinical regulatory documents (US and ex-US).
  • Coordinates the review, approval, and other appropriate functions involved in the production of clinical regulatory projects.
  • Serves as a department representative on project teams.
  • Communicates deliverables needed, writing process, and timelines to team members.
  • Converts relevant data and information into a form that meets clinical regulatory document requirements.
  • Ensures all clinical regulatory electronic document deliverables are processed and compiled in alignment with timelines.
  • Assesses resource needs as timelines progress, and communicates those needs to department management.
  • Understands, assimilates, and productively interprets sources of information, with appropriate guidance/direction from product teams and/or authors.  Ensures required documentation is obtained.
  • Interprets and explains data generated from a variety of sources, including internal and external studies, research documentation, charts, graphs, and tables.
  • Explains data in manner consistent with clinical regulatory requirements.
  • Confirms completeness of information to be presented. Challenges conclusions when necessary.
  • Understands/complies with appropriate conventions, proper grammar usage, and correct format requirements per ICH and other governing bodies by following applicable divisional guidelines, templates, and SOPs.
  • Arranges and conducts review meetings with the team.
  • Independently resolves document content issues and questions arising during the writing process.
  • Performs literature searches as needed for drafting document content. Interprets literature information and makes recommendations for application to clinical regulatory documents.
  • Acts as Subject Matter Expert for assigned clinical teams regarding computer-based technologies utilized by the respective departments.
  • Maintains expert knowledge of US and international regulations, requirements and guidance associated with clinical regulatory document preparation and submissions.
  • Recommends, leads, and implements tactical process improvements.
  • Serves as medical writing lead on more complex clinical regulatory documents such as those associated with filings and dossiers. Works closely with Regulatory on document strategies.


Qualifications/ Requirements:
  • Bachelor of Science required, with significant relevant writing experience, or Bachelor' s degree in English or communications, with significant relevant science experience.
  • 4 yrs relevant industry experience in medical writing in the healthcare industry or academia required or in a related area such as quality, regulatory, clinical research, or product support/R&D.
  • High-level content writing experience and experience with all types of clinical publications or clinical regulatory documents required.

Preferred:
  • Masters or PhD in science discipline preferred with relevant writing experience.
  • American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Editing/Writing or Pharmaceutical.
  • 2 years relevant industry experience preferred.
  • 4 years experience in experimental design and clinical/preclinical data interpretation preferred.
  • Expert knowledge of US and international regulations, requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions and ability to advise teams regarding compliance with regulations.
  • Knowledge and expertise with Common Technical Document content templates.
  • Expert knowledge of current electronic document management systems and information technology.
  • Excellent written and oral communication skills. Expert in assimilation and interpretation of scientific content with adeptness in ability to translate for appropriate audience.
  • Working knowledge of statistical concepts and techniques.
  • Superior attention to detail and ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy.
  • Expert in word processing, flow diagrams, and spreadsheets.
  • Excellent working knowledge of software programs in Windows environment.
  • Extensive experience in working with collaborative, cross-functional teams, including project management experience.

Key  Competencies:
  • Builds strong relationships with peers and cross functionally with partners outside of the team to enable higher performance.
  • Learns fast, grasps the “ essence” and can change the course quickly where indicated.
  • Raises the bar and is never satisfied with the status quo. Creates a learning environment, open to suggestions and experimentation for improvement.
  • Embraces the ideas of others, nurtures innovation and manages innovation to reality.
]]>
Tue, 05 Sep 2017 00:00:00 EDT 0
<![CDATA[Receptionist/Admin]]> Job Responsibilities
  • Answer phones, greet visitors
  • Act as Office Coordinator and Administrative Assistant providing support to the Accounting and Finance team and HR
  • Responsible for mail, order supplies, replenishing conference rooms with necessary items, etc.
  • Data entry work into Excel or into the accounting software, SAGE,  basic Excel skills required.
  • Scan invoices and mail out checks to vendors
  • Looking for someone with  strong degree of professionalism.


Qualifications/Requirements:
  • Previous experience working in an office as a Receptionist/Administrative Assistant
  • Must be onsite 5 days a week. Hours 8-5
]]>
Wed, 30 Aug 2017 00:00:00 EDT 0
<![CDATA[Assistant VP - Financial Reporting]]> This position will report to the Vice President of Financial Reporting.  The role includes leading external and internal reporting processes, maintaining accounting policies, and addressing accounting inquires for an industrial real estate platform spanning multiple investment portfolios and geographic markets.  This role requires coordinating and liaising with multiple levels of management and the external auditors, coordinating the flow of information, and the compilation and writing of GAAP/IFRS compliant financial statements.  This position also includes technical accounting and research in order to provide management with timely information for decision-making and analysis.  It will manage significant projects such as new policies, new types of transactions, impairment testing and training initiatives. 

This position will entail a significant amount of coordination between various corporate departments including Finance, Property Accounting, Accounts Receivable, Accounts Payable, Treasury, Legal, Lease Administration, and Tax, as well as a geographically dispersed team of field personnel.  Candidate is expected to possess strong communication skills along with the ability to work under tight deadlines and in a fast paced environment.  Analytical skills are a must along with a proficiency in synthesizing large quantities of data using Excel or similar tools. 

Job Responsibilities:
  • Coordinates and prepares monthly and quarterly internal and external financial information and reporting in accordance with US GAAP and IFRS.
  • Lead the annual impairment testing for Investments in Real Estate.
  • Monitor US GAAP and IFRS developments and evaluating the impacts of new accounting and reporting rules.
  • Evaluate the proper accounting treatment for complex or non-standard transactions and stay abreast of technical accounting issues pertaining to the real estate industry.
  • Develop and update accounting policies, as well as necessary internal communications on accounting policies and US GAAP updates.
  • Assist with accounting research efforts, including the development of position papers on accounting matters.
  • Provide guidance and support to corporate and operating company personnel on technical financial matters (e.g. purchase price accounting, accounting for leases, stock compensation, income taxes, impairment, environmental liabilities, acquisitions and dispositions)
  • Assist in special projects related to reporting issues, budgets, acquisition and disposition activity, accounting and reporting, as they become necessary.
  • Liaise with external auditors and coordinate annual audit.
  • Ad-hoc projects and analysis as assigned.
  • Communicates with various departments within organization as needed in regards to analysis and reporting.


Qualifications/Requirements:
  • Minimum of 8 years of total experience, with “ Big Four” or national accounting firm audit experience preferred, with strong US GAAP and IFRS accounting experience
  • Commercial real estate experience preferred
  • Fund/portfolio consolidating or REIT financial reporting experience in public accounting and/or industry
  • Strong project management experience
  • Very strong communication skills, both written and verbal (including public speaking skills)
  • Excellent interpersonal and conflict management skills
  • Ability to work efficiently and achieve results, while maintaining high quality
  • Excellent analytical, teamwork, customer service and leadership skills
  • Proficient in Microsoft Excel
  • Familiarity working with General Ledger accounting software (e.g. JD Edwards)
  • Entrepreneurial attitude
  • Ability to multi-task and work under tight deadlines and with competing priorities, as well as adapt quickly to changing circumstances
  • Exceptional work ethic
  • Bachelors and/or Master’ s Degree in accounting or equivalent
  • CPA required
]]>
Fri, 25 Aug 2017 00:00:00 EDT 0
<![CDATA[HR Manager]]> Our client is a leader in transforming logistics and supply chain management into a critical business strategy based on collaborative partnerships, innovative thinking and high-performance operations. They achieve the business goals of Fortune 500 and other dynamic companies by designing, integrating, managing and adapting customized supply chain solutions. As a Lead Logistics Partner   and third-party logistics provider, they deliver value by reducing total system costs, optimizing business processes, facilitating growth and change, and maximizing the potential of the supply chain. In today’ s environment, filled with rapid and unpredictable change, they help customers achieve their goals

Our client is looking for a dependable and skilled  Human Resources Manager  at their Des Plaines facility. 

Job Responsibilities:
  • Operations Management  Lead the human resource effort to ensure all polices, processes and regulations are adhered to in a consistent and timely manner. Responsible for staffing, on-boarding and retaining top talent to execute and achieve business goals.
  • People Leadership:  Partners with senior HR leader and operational team to develop a culture of positive employee relations and engagement. Responsible for providing training, coaching, and counseling to develop a strong team and improve retention. Partners with senior HR on employee issues and/or complaints to ensure all concerns are investigated thoroughly, documented properly and resolved in a timely manner.
  • Information & System Management:  Maintain a thorough knowledge of the HR systems and operational systems as it relates to human resources. Responsible for utilizing the systems to accomplish the goals of the business ensuring accurate data is submitted in a timely manner. Maintain a high level of integrity and confidentiality when utilizing the data. Provide information to the appropriate stakeholders to support the success of the operation.


Qualifications/ Requirements:
  • 4 to 6 years in human resource management role
  • Bachelor’ s degree required
  • SHRM or HRCI certification preferred
  • Demonstrated leadership skills
  • Strong written and verbal communication skills

Internal/External Contacts:
  • Reports to Senior HR Manager
  • Vice President, Group General Manager and/or General Manager
  • Logistics Managers
  • Corporate HR Team
  • Payroll Team
  • Hourly Employees

 
]]>
Fri, 11 Aug 2017 00:00:00 EDT 0
<![CDATA[HR Generalist]]> The HR Generalist will be responsible for all day-to-day employee relations issues, contribute to the efforts in recruitment and retention, workforce development and training and compensation and benefits; which involves planning, developing, recommending, and implementing HR activities, policies, procedures, and programs.   This position works a 4 day on / 3 day off schedule and will require relocation to Juneau, AK.

Job Responsibilities:
  • Ensures proper and timely recruitment activities for company personnel including creation of job descriptions, requisitions and recruitment advertisements; partners with state employment agencies and professional recruiters as needed.
  • Communicates with site leaders and managers on HR initiatives as they relate to business priorities.
  • Works with Corporate HR Team to ensure consistency and best practice sharing to leverage with the Alaska site.
  • Assist with employee relations issues including performance evaluations, promotions, and administration of discipline and performance improvement plans; conducts exit interviews.
  • Attends meetings, conferences, job fairs, seminars, and similar events as required or directed.
  • Contributes to the creation and facilitation of training program(s).
  • Serves as company liaison and employee advocate with third-party benefits administrations.
  • Contribute new approaches, policies, and procedures to effect continual improvements in efficiency of department and services performed.
  • Ensures departmental compliance with all local, state, federal and company rules.
  • Demonstrates required behavioral skills including productive communication, cooperation, productivity, initiative, creativity, dependability


Qualifications/ Requirements:
  • Ability to work safe and promote safe behavior in others.
  • Bachelor’ s degree in HR Management or other related discipline.
  • Minimum  3-5 years exempt level of human resources generalist experience.
  • Knowledge of current employment law, and applicable state and federal laws and requirements, as well as human resources policies and procedures.
  • Sets high standards for self and others, builds trust and takes accountability.
  • Other duties as assigned.
  • Preference given to Alaskan applicants.
]]>
Thu, 10 Aug 2017 00:00:00 EDT 0
<![CDATA[HR Manager]]> The Human Resources Manager supports the Human Resources Department with the overall administration, coordination, and evaluation of the Human Resources functions and processes.  This includes management of the data in the Human Resources Information System (HRIS), records management, and collaborating closely with the Leadership Team, divisions, and employees in regards to all aspects of Human Resources.

The Human Resources Manager reports to the Chief Financial Officer.

Job Responsibilities:
  • Manage and administer all payroll activities including ensuring timely processing of payroll and all financial obligations related to the payroll process.  Develop yearly payroll schedules and maintain updated payroll documentation including processes.  Manage requests from employees, agencies, worker’ s compensation, benefits vendors, etc. 
  • Manage administrative tasks, including on-going maintenance of personnel records and employment verifications. 
  • Manage the HRIS including employment transactions, applicant tracking system, reports and processes, the employee portal, and self-service tools. 
  • Develops and administers various Human Resources plans and procedures for all company personnel.  This includes acting as a strategic business partner to the leaders, effectively communicating plans, processes, and administration to company. 
  • Manages and resolves complex employee relations issues. Conducts effective, thorough and objective investigations.  Interprets and communicates policies and best practices.
  • Administer employee benefits programs, including retirement plans, medical plans, life insurance plans, temporary disability programs, accidental death policies, employee assistance programs, worker’ s compensation, and unemployment claims.
  • Conducts training on various Human Resources requirements. 
  • Files EEO-1 annually as well as OSHA logs; maintains other records, reports and logs to conform to EEO regulations.  
  • Ensures compliance with all federal, state and local employment laws in multiple states.    
  • Evaluates reports, decisions, and results of department initiatives in relation to established goals. Recommends new approaches, policies and procedures to effect continual improvements in efficiency of department and services performed. 
  • Conducts recruitment effort for all exempt and nonexempt workers; writes and places advertisements; works with supervisors to screen and interview candidates; extends job offers; complete background check; conducts new-employee orientations; monitors career-path program and employee relations counseling; conducts exit interviews. 
  • Review and rewrite job descriptions as necessary.
  • Manages multiple HR project initiatives to support departmental and corporate goals.  
  • Develop and execute employee recognition programs. 
  • Develops, recommends and implements personnel policies and procedures; maintains handbook on policies and procedures; 
  • Maintain employee compliance with the federal and state regulations concerning employment.


Qualifications/ Requirements:
  • Bachelor’ s Degree in Human Resources or Business Administration, or equivalent work experience preferred
  • Five (5) or more years of Human Resources experience 
  • Five (5) years of experience with ADP Workforce Now and Time and Attendance Platforms including setting up validation tables and coding within system 
  • Strong understanding of Human Resources best practices and the ability to effectively collaborate and work in team environment.
  • Excellent presentation, communication, and interpersonal skills
  • Excellent problem solving skills
  • Ability to multi-task in a high volume environment and exercise effective judgment while working at a fast pace
  • Sensitivity and creativity to changing needs, situations, and people
  • Able to establish and maintain healthy working relationships with people 
  • Excellent Excel skills
]]>
Thu, 10 Aug 2017 00:00:00 EDT 0
<![CDATA[Assistant Director of Nursing]]> There’ s a reason you chose healthcare as your life’ s work. Our client, a Senior Living Community, would like to help you rediscover it. If there’ s a part of you that is looking for deeper levels of engagement with both residents and colleagues, we encourage you to consider joining   our client, as an ADON – in a place like no other with people like no other... a luxury work environment where opportunities for career development are delivered in ways few companies can match. 

Job Responsibilities:
  • The candidate selected for this dynamic role will oversee all aspects of care and services provided in the Care Center, which includes assisted living, memory support, and skilled nursing. 
  • As a natural leader, the professional serving as Assistant Director of Nursing will supervise the nursing staff and support the Director of Nursing with clinical, financial, human resource, and quality assurance/performance improvement activities.
     

Qualifications/Requirements:
  • 3+ years of experience with geriatric populations, to include knowledge of regulatory compliance and Continuing Care Retirement Community or Assisted Living/Memory Support operations
  • Prior supervisory experience strongly preferred
  • Graduation from an accredited school of nursing, current state licensure, and CPR/AED certification 
  • Excellent communication and interpersonal skills with a courteous and customer-centric approach to problem-solving and goal-setting
  • PC skills (MS Office) are a must
]]>
Mon, 31 Jul 2017 00:00:00 EDT 0
<![CDATA[Director of Compensation and Benefits]]> Our Client currently has an opportunity for a Director of Compensation and Benefits responsible for designing, developing and implementing efficient and effective compensation and benefit programs to meet current and future business needs and maintain a competitive advantage for the business as a whole. 

Job Responsibilities:
  • Analyze the effectiveness of existing compensation policies, guidelines, and procedures, recommending plan revisions, as well as new plans which are cost effective and consistent with compensation trends and corporate objectives; drives implementation and provides guidance to Sr. Executives, Management and HR staff.
  • Partner closely with company business leaders on a variety of compensation and benefit matters, including those related to the Company' s expansion initiatives.
  • Be on the forefront of evolving practices related to all aspects of Total Rewards; provide expert counsel and guidance to senior management on programs that are competitive in the industry and frequently benchmark best practices.
  • Ensure that all aspects of plan design and administration remains in compliance with applicable Federal, State and Local rules and regulations.
  • Provide recommendations to Sr. Executives, Management and HR staff on pay decisions, policy and guidelines interpretation and job evaluation, including the design of creative solutions to specific compensation-related programs.
  • Manage the administration of direct compensation (executive, exempt and nonexempt, cash compensation programs) including the processing, recording and reporting of compensation-related actions taken on salaried employees.
  • Direct the participation in market relevant exempt and nonexempt salary surveys to ensure corporate compensation objectives are achieved.
  • Manage the merit and bonus processes and makes program design recommendations based on relevant market data as defined by company compensation philosophy.
  • Research, analyze and recommend modifications to existing benefits plans to improve services to employees in a cost effective manner.
  • Oversee benefit plan contract negotiation meetings with vendors.
  • Recommend and help implement enhancements to benefits and compensation modules in the HRIS.
  • Partner with our corporate communications team as it relates to employee benefit communications.
  • Partner with our FK Global HR colleagues to implement global strategies and requirements. 


Qualifications/ Requirements:
  • Bachelor’ s degree; Masters preferred; Professional Certification desired
  • 7-10 years of management experience in compensation and benefits
  • Knowledge of HRIS and payroll systems
  • Advanced skills in Microsoft Excel and Word
  • Excellent verbal and written communication skills
  • Ability to communicate effectively with all levels of the organization
]]>
Tue, 25 Jul 2017 00:00:00 EDT 0
<![CDATA[Clinical Operations Nurse]]> Our client in the Western Suburbs is looking for a Clinical Operations Nurse.

Job Responsibilities:
  • Participate in survey education and quality spot review process in assigned facilities as scheduled.
  • Implement follow-up in facilities in response to mock survey results.
  • Review incidents/occurrences and monitor for appropriate follow-up documentation and interventions; analyze incidents for trending and determination of further clinical needs.
  • Obtain significant occurrence documentation and submit to the VP of Risk Management.
  • Provide clinical information on legal claims as needed.
  • Collaborate with the other Clinical Operations Nurses, VP of Clinical Operations, VP of Risk Management and Quality Assurance, to review company trends related to resident incidents and develop proactive interventions and programs to reduce company risk.
  • Identify necessary educational opportunities which would benefit the facility staff opportunities to the Director of Training and Development and determine appropriate action plans.
  • Provide education and staff competencies in support of action plans.
  • Utilize Quality Improvement tools to evaluate resident outcomes, and staff performance and behaviors.
  • Manage most of the IDPH process; a) reviewing the Plan of Correction(POC) b) setting an appropriate date of completion for the POC c)reviewing the evidence of compliance d) monitoring for IDPH feedback and working with Royal Clerical Support on calendar time frames for compliance e) obtain necessary documentation for the Informal Dispute Resolution (IDR) process.
  • Conduct chart reviews as necessary and review areas of risk with the appropriate personnel.
  • Partner with the facility Director of Nursing and provide guidance as necessary in meeting resident needs.
  • Assisting other team members when necessary

Job Requirements:
  • Bachelor' s Degree preferred.
  • A team-focused, experienced Registered Nurse, RN, with 3+ years Director of Nursing experience in a long term care facility.
  • Strong communications skills.
  • Knowledge of state and federal regulations.
  • Ability to multi-task and prioritize.
  • Demonstrated ability to critically analyze data and provide guidance to the facility on an appropriate plan.
  • Must be able to read, speak and understand the English language.
  • Must have the ability to sit, stand, walk, stoop and reach, and to use hands to manipulate the computer, writing, calculation or other instruments to carry out responsibilities of the position.
  • Must be able to lift objects up to 20 pounds.
  • Must have adequate vision to perform essential job functions.
]]>
Mon, 17 Jul 2017 00:00:00 EDT 0
<![CDATA[Administrator]]> Our client in the South Suburbs is looking for an Administrator for their Long Term Care Facility.

Job Description:
  • The Administrator is responsible for organizing, staffing, directing, coordinating, reporting, budgeting, inventory control, and management of the facility, people, supplies and equipment in partnership with their direct reports in such a way that meaningful services are established to render the optimum level of resident care.
  • This individual is expected to develop and encourage a teamwork approach within the facility and corporate structure as it pertains to facility issues.
  • Promotion of the facility’ s Culture Contract in all aspects of their role, both for residents, families and staff.
  • Oversee the recruitment, retention, and orientation practices of new employees within the Social Service Division, Activity Division, Dietary and Environmental Service personnel
  • Complete personnel records for all areas of supervision including: Hiring, counseling and terminating employees
  • Evaluation/performance review of all personnel
  • Management of the overall social services and activity programs
  • Oversees the activity budget
  • Management of the facility Information Management systems
  • Supervision of the Dietary department by working in a collaborative manner with the Food Service Supervisor to provide nutritious meals following dietary standards
  • Oversees the Environmental Services department and working in a collaborative manner with the Environmental Services Director to provide a sanitary living environment for the residents
  • The Administrator  is considered the Site Information Systems (IS) Coordinator within the facility. As the Site IS Coordinator, the Administrator  should be familiar with computers and the Windows environment, and willing to learn and share information with other computer users in the facility regarding the utilization of the facility software and network. Responsibilities include:
  • Oversees the facilities network backup
  • Communication between the facility and the corporate MIS department regarding electronic policies and procedures, computerized management reports and other important computer files
  • Communication between the facility and the corporate MIS department regarding software, hardware and network maintenance
  • Communication between the facility and the corporate MIS department regarding all computer related training needs
  • Assist other team members when necessary

Job Qualifications:
  • Active Licensed Nursing Home Administrators License in good standing.
  • Bachelor' s degree from a four-year college or university.
  • Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
  • Ability to write reports, business correspondence, and procedure manuals.
  • Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
  • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
  • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
  • To perform this job successfully, being able to manipulate through programs on the computer. Knowledge of Excel Spreadsheet software and Microsoft Word software.
  • Must be able to read, speak and understand the English language.
]]>
Mon, 17 Jul 2017 00:00:00 EDT 0
<![CDATA[Medical Reviewer/Safety Reviewer - C]]> Our client is in search of a Medical Reviewer/Safety Reviewer to join their team in the northern Chicago area.

Job Responsibilities:
  • Reviews safety-related data from clinical trials for content, quality, adherence to regulatory guidance and protocols.
  • Triages SAE information in order to fulfill timely reporting according to the authority/regulatory requirements. Participates in applicable safety surveillance activities for assigned products. Collects, analyzes, and triages AEs including reporting SAEs to IND safety. Assessment of AE coding for consistency and accuracy of coding.
  • Medical review of safety-related CRFs and labs, including communication with Study Physicians. Interface with study manager, CROs, CRAs, Data Management, PV to assure query resolution.
  • Creation of narratives of SAEs and other identified AEs of interest in accordance with accepted standards and with minimal revision required upon review.

Job Qualifications:
  • MUST BE AN RN.
  • 3-5 years of clinical experience is required.
  • Computer proficient (Windows, Word, Excel).
  • Able to present adverse event data, orally and in writing.
  • Pharma experience recommended.
  • Broader knowledge of ICH/FDA regulations and guidelines affecting drug safety issues preferred.
]]>
Fri, 14 Jul 2017 00:00:00 EDT 0
<![CDATA[Clinical Data Coordinator - B]]> Our client is in search of  Clinical Data Coordinator to join their team in the northern Chicago area. 

Job Responsibilities: 
  • Central “ Point of Contact” for all Clinical Supply Management System related matters. Receives all support calls related to the system or any of the connected systems / reports / interfaces.
  • Determine issue criticality and identifies next steps.
  • Responsible for Master Data management
  • Resolve error messages received through the system interfaces
  • Assist in SOP development and maintain business practices
  • Perform or Assist in System Training Activities
  • Perform report development and implementation of non- validated reports

Job Qualifications/Requirements: 
  • Bachelor’ s Degree or equivalent experience
]]>
Fri, 14 Jul 2017 00:00:00 EDT 0
<![CDATA[Clinical Research Associate (CRA) - C]]> Job Responsibilities:
  • Assist the Study Project Manager on study related activities for one or more studies. Coordination of study activities for a cross-functional team during the initiation, conduct and close-out of one or more clinical studies. Activities to include: study design, protocol preparation, investigator selection, investigator meeting planning, contract preparation, vendor selection, CRF design, development of monitoring plan and other activities to ensure on time completion of studies.
  • Identify site issues that potentially impact study data, study conduct and ICH compliance. Escalate issues and make recommendation for corrective action.
  • Assist with vendor management of CROs, Central Labs, Central Imaging and other suppliers. Perform review and approval of site and vendor invoices.
  • Assist Medical Writing with statistical table review and QC
  • Plan and track study progress for adherence to timelines
  • Experience with EDC is required and should include the review of data listings and query resolution
  • Responsible for compliance with applicable Corporate and Divisional Policies and procedures

Qualifications/Requirements: 
  • 3 - 5 yrs experience
  • Experience with EDC is required
  • Safety review experience preferred
]]>
Fri, 14 Jul 2017 00:00:00 EDT 0
<![CDATA[Senior HR Business Parnter]]> Our client in the Northern Suburbs is looking for a Senior  HR Strategic  Business Partner

The Senior HR Strategic Business Partner is focused on driving business success by providing HR leadership, partnership and support to certain business units.  This is done by partnering to ensure HR strategy is aligned with business to achieve goals while maximizing human capital. 

Job Responsibilities:
  • Engaging with the Business - Understands needs of the business unit(s) and processes and the link between HR strategy and business strategy for those areas supported
  • Catalyst for Change - Applies change management and organizational development strategies, influences and assists organizational change initiatives in support of business strategies for specific business unit(s).
  • Culture Catalyst - Aligns actions to proactively support culture. Champions efforts in serving our people, clients, business and communities. As a trusted advisor and authentically humble, stays true to values regardless of internal/external pressures. 
  • HR Delivery Excellence - Ensures that HR services are provided as appropriate to internal client needs, identifies new opportunities where HR can add value, and maintains leading-edge knowledge of HR issues.  Knows the goals and also the big picture view.  Thinks divergently, as well as, critically and align.
  • Championing Employee Needs - Understands employee opinions, monitors the effect of business decisions on people, and advises management on addressing employees’ concerns
  • Performance - Effectively applies performance management to create a high-performance culture
  • Reward - Understands, communicates, and applies reward strategy
  • HR Analytics - Ability to develop and use metrics to make the business case for HR programs, to align HR strategy with goals, and to assess and justify the performance of HR/business programs.  Also, use data to predict talent gaps in advance and provide insights into how talent relates to business goals.
  • Employee Relations - Applies employee relations and employment practices in order to create a positive, ethical, effective work environment.  Grows relationships while maintaining confidentiality.
  • Relationship Building - Build effective relationships within HR and external to HR with business leaders and employees.
  • Transactional Knowledge - Ability to use knowledge about legal and HR processes to solve problems


Qualifications/ Requirements:
  • BA/BS in Human Resources, Business, or related concentration
  • PHR/SPHR certification preferred
  • 8+ years of experience in a human resources and talent management environment, with proven ability to produce positive results.
  • Preferred Healthcare, Medical or Corporate experience, but we will consider other industries as well.
  • Strategically partners with senior leadership to manage complex business initiatives and effectively meet the needs of businesses.
  • Solid knowledge of all MS Office Products
  • Travel:  10%
]]>
Thu, 06 Jul 2017 00:00:00 EDT 0
<![CDATA[Technical Writer]]> The primary responsibility of the person hired will be to support R&D Innovation through  tech-edit all components of the company' s training and certification product suite. Other responsibilities include fulfilling other tech-editing needs as capacity allows for the company' s product suite.This is a 6 month contract role with potential for extension. 

Job Responsibilities:
  • Training and Certification Technical Editing of various types of files
  • Tech editing for as needed
  • Incorporation existing and creation of additional design images for  training and marketing purposes


Qualifications/Requirements:
  • BS degree in English, Business Writing, or relevant from an accredited institution
  • 5 years of relevant experience in technical writing
  • Previous history and work experience in content management editing
  • Previous experience and work history with image and infographics creation
  • Graphic design exposure/background
  • Global work history
  • Professional Association/volunteer engagement
  • Non-profit
  • Multi lingual
  • Cultural sensitivity
  • Multilingual
  • Ability to work independently
  • Excellent oral, and written communication and presentation skills (ability to present new ideas, approaches, and information clearly)
  • Results Oriented, focused, highly motivated, self-starter
  • Attention to detail
  • Ability to effectively multi-task, manage multiple projects simultaneously, and meet deadlines
  • Diligent work ethic and insatiable desire to learn and develop skills
  • Ability acquire new knowledge quickly
  • Strong interpersonal skills
  • Time management, organizational skills
  • Cultural sensitivity/awareness
  • Team player, ability to build strong relations internally across functional areas and externally with vendors, suppliers, members, constituents, and volunteers
  • Commitment to company purpose and values
  • Proficiency in Microsoft Office products (Word, PowerPoint, and Excel)
  • Collaborative
  • Strong business acumen
  • Creativity and entrepreneurial skills
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Fri, 09 Jun 2017 00:00:00 EDT 0
<![CDATA[Director of Nursing]]> Our client in the Northwest Suburbs is looking for a Director of Nursing:

Job Responsibilities:
  • Develop and maintain nursing service objectives, standards of nursing practice, and the implementation of nursing policies and procedures
  • Oversee the recruitment, retention and the orientation practices of nursing and restorative/rehab staff
  • Provide sufficient staff to ensure uninterrupted service to the residents at all times
  • Maintain a procedure to ensure that all licensed personnel have a current and valid license as required by the State, and that the State of Illinois appropriately registers all certified personnel
  • Maintain personnel records for all nursing staff (hiring, counseling, and terminating employees)
  • Evaluation/performance review oversight of all personnel under the direction of the Director of Nursing
  • Develops rapport with residents and families and develops systems to encourage communication between residents/families/staff
  • Develops/implements communication patterns between food service, and nursing departments
  • Develops/implements communication pattern between restorative/rehab department and nursing departments
  • Responsible for the fiscal management of the nursing department
  • Responsible for the oversight of the nursing management team and the development of their teamwork approach in providing the best clinical outcomes for the residents
  • Responsible for nursing department annual mandatory inservices
  • Provide clinical support, as needed, to other facilities within the corporation
  • Oversees the process of evaluation and assessment of employee injuries to determine the need for treatment in an outside facility. Works in conjunction with the facility Human Resources Manager to exchange information and to coordinate a complete filing with the workers’ compensation carrier. Follows up with documentation of work status orders of employees receiving treatment.
  • Acts as a member of the Quality Assurance Committee and utilizes available reports and information to develop and prioritize plans for improvement if necessary
  • Responsible for identifying, investigating trigger events in accordance with state, federal and organization guidelines
  • The DON has a leading role in promoting through role modeling, education and program development the facility’ s Culture Contract components
  • Promotes and partners with all facility staff to provide quality customer services.
  • Assist other team members when necessary
  • All other duties as assigned


Qualifications/ Requirements:
  • Full-time RN who has knowledge and training in nursing administration and restorative/rehabilitative nursing.
  • Knowledge and training of geriatric residents.
  • Graduate of an accredited nursing program with an Illinois RN license.
  • CPR certified
  • Possess excellent communication skills
  • Nursing Home Administrator’ s license is a plus
  • Must be able to read, speak and understand the English language.
  • Must be able to propel a patient / resident in a wheelchair.
  • Must be able to move items at least 15 pounds.
  • Must be able to assist patients /residents in evacuating the building in an emergency
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Mon, 22 May 2017 00:00:00 EDT 0