<![CDATA[The Steely Group: jobboards]]> http://JOBS.THESTEELYGROUP.COM/ en-us <![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
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Mon, 11 Dec 2017 00:00:00 EST 0
<![CDATA[Sr. Medical Director, Surveillance and Risk Management]]> Our client is seeking a Sr. Medical Director, SRM and they will serve as the global lead for surveillance and risk management of all products marketed and in development.   This key position will lead a team of medical doctors and PV scientists, and interact across functions and at various management levels. The head of SRM and his/her team are responsible for the detection and investigation of safety signals, assessment of the need for risk mitigation activities, and the continuous benefit risk evaluation of all products. This role will interact with senior management and closely collaborate with colleagues from other functions such as Clinical Research, Regulatory Affairs, Data Science, Medical Affairs, Clinical Operations.

Job Responsibilities:

Key responsibility is to build and lead a high performing team of medical safety experts to:
  • Medically assess ICSRs from development and post-approval sources
  • Have an in depth understanding of product’ s safety profile as well as the patient profile in approved or studied indications
  • Monitor patient safety in clinical trials, in close collaboration with Clinical Research and Data Sciences
  • Lead Safety Management Teams
  • Evaluate safety data from various sources, including literature, clinical trials, internal and external safety databases. Propose proactive PV Strategies.
  • Apply, or introduce best industry practices to safety surveillance, including signal detection and assessment as well as benefit-risk evaluations.
  • Apply sound judgment in matters of recommended actions including label updates, risk mitigating activities and communications to health authorities, prescribers or consumers.
  • Produce excellent aggregate benefit-risk reports, and scientifically sound discussions and summaries, in support of decision making
  • Develop and propose post-market risk management plans, risk mitigation strategies as needed and monitor effectiveness

At the individual level, the head of SRM will:
  • Play a key role in the Company Safety Oversight Committee.
  • Interact with health authorities related to safety matters
  • Present to investigators, or other medical or professional audiences
  • Approve regulatory and clinical documents for submission.
  • Present or represent the DS PV position where needed
  • Report to the VP Drug Safety and Pharmacovigilance


Qualifications/ Requirements:
  • MD, DO, or equivalent
  • Minimum of (2) years Clinical experience after medical education
  • Minimum of (10) years industry experience in Pharmacovigilance and Risk Management
  • Track record of successfully leading teams.
  • Track record of successful safety issue management
  • Training or experience in quantitative research, epidemiology, public health
  • Extensive experience in both investigational and post-approval context
  • Board certification is a plus
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Thu, 07 Dec 2017 00:00:00 EST 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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Wed, 06 Dec 2017 00:00:00 EST 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.
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Wed, 06 Dec 2017 00:00:00 EST 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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Wed, 06 Dec 2017 00:00:00 EST 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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Wed, 06 Dec 2017 00:00:00 EST 0
<![CDATA[Manager - Drug Safety and Pharmacovigilance Quality & Compliance]]> The Drug Safety & Pharmacovigilance Department (DSPV) Q&C Manager is responsible for supporting the DSPV Quality & Compliance activities based on relevant regulations, procedures, and contractual requirements.   Through implementation of quality and compliance tracking tools, oversight strategy and relationship management, this role will support the management of all DSPV SOPs, CAPAs and inspection related activities, as well as leading a QC system for all DSPV documents.   The DSPV Q&C Manager will manage a global DSPV training program, including the implementation, tracking, maintenance, and effectiveness checking of all DSPV training activities. The incumbent will support the organization and maintenance of a DSPV compliance system with metrics.

Job  Responsibilities: 
  • Support DSPV process improvements including authoring controlled procedures, maintaining the DSPV procedures Index, leading meetings of subject matter experts to revise procedures and merge procedures, to reduce the total number of procedures for improved efficiency, where possible
  • Maintain the DSPV project tracking tool for quality and compliance oversight
  • Participate in Pharmacovigilance Agreement creation and revision
  • Support DSPV quality system, which includes supporting the management of all DSPV SOPs, CAPAs, and inspection related activities, as well as a QC system for all DSPV documents
  • Support the development and management of a quality system for DSPV documents including ICSRs, PSUR, DSURs, ad hoc reports, compliance and performance metrics, alliance management and signal detection activities
  • Help to ensure the development, effectiveness evaluations, and compliance with DSPV SOPs.  Where there is cross-reference and/or cross functionality with other functional controlled procedures, ensure DSPV SOP alignment
  • Support Research Quality Assurance (RQA) by engaging and providing support of the RQA pharmacovigilance/clinical safety audit plan, compliance, audit and inspection activities, inspection readiness and other cross functionality
  • Serve as the primary point of contact for DSPV controlled documents (i.e. SOPs, WIs, etc.) and DSPV training and as the subject matter expert for these topics during audits and inspections
  • Monitor global pharmacovigilance regulatory intelligence to determine impact on pharmacovigilance quality system
  • Assist in monitoring DSPV commitments from internal audits, regulatory inspection findings, and CAPAs
  • Make contributions to the PV System Master File (PSMF) to ensure it is maintained on a regular basis
  • Contribute to the collection, organization, and presentation of all required global DSPV compliance metrics including vendor and partner oversight metrics
  • Lead and support the development and implementation of the global DSPV training strategy (training matrix development, process, content, delivery, system, tracking, metrics)
  • Lead and support the development, delivery, implementation, maintenance, and tracking of all DSPV training materials including tests for verification of training completion and effectiveness
  • Develop methods to determine the effectiveness of DSPV training and initiate improvements as required
  • Represent DSPV training on cross-functional learning initiatives and partner with related departments (Learning & Development, IT, Commercial Training, etc.) accordingly
  • Support the development, design & maintenance of compliance metrics, CAPA management for DSPV business process, and monitoring of trends with proposed remediation actions
  • Lead and Support DSPV compliance and alliance activities
  • Assist in DSPV preparation and inspection activities during Regulatory Agency inspections and internal audits
  • Remain current with global pharmacovigilance regulations and requirements, evaluate legislative changes affecting DSPV, and develop strategies to support the patient safety at the local level
  • Lead projects related to DSPV quality, training, and compliance activities, provide DSPV compliance and alliance advice and visibility to the company


Qualifications/ Requirements: 
  • Bachelor’ s Degree or equivalent work experience in a scientific or technical discipline
  • Must have a minimum of 5+ years of experience in the areas of GXP regulations with
  • 3-5+ years of experience in a quality and compliance role within pharmacovigilance highly preferred
  • Demonstrated analytical and process skills and the ability to apply these skills to PV organization
  • Analyze and interpret regulations and laws and apply to current and future policies and procedures (may include collaboration with other cross functional areas)
  • Global mindset required
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Wed, 06 Dec 2017 00:00:00 EST 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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Fri, 01 Dec 2017 00:00:00 EST 0
<![CDATA[Claims Admin/Coordinator]]> Our client is in urgent need of someone to help coordinate and process property claims. This individual will be responsible for quickly getting up to speed on our client' s policies, discussing property damage with the property managers and entering the information in to our client' s system so that the claims process can begin.  The claims themselves will be managed by a 3rd party vendor.

Job Responsibilities
  • Use advanced Excel skills to enter and maintain  a complex google sheet- must have experience CREATING v-lookups and pivot tables.
  • Must be able to calmly, quickly and efficiently work with the operations and accounting executives to process claims
  • Will work under  pressure  in a highly matrixed environment and must possess the ability to manage communications both up and down the chain of command is a must. 
  • Collect  data for tracking hurricane loss, potentially managing the process.
  • Use advanced Excel skills to enter and maintain  a complex google sheet- must have experience with v-lookups and pivot tables.
  • Work  with properties to collect data to  support  claims for loss 
  • Communicate  with range of people,  supporting the properties and  understanding issues
  • Work  with accounting on recording and reporting
  • Work with financial planning on loss cost
  • Work  with broker claim specialist and potentially consolidator and adjuster on claim
  • Coordinate   meetings and site visits


Qualifications/  Requirements:
  • Property claims experience a very big plus.
  • Exceptionally strong Excel skills -must have experience working with v-look-ups and pivot tables
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Thu, 30 Nov 2017 00:00:00 EST 0
<![CDATA[Sr. Clinical Project Manager]]> Responsible for the planning, implementation, execution and management of multiple clinical studies by overseeing day-to-day operations and directly managing outside Clinical Research Organizations.

Job  Responsibilities:
  • Represents and leads the study team to design, develop and deliver the clinical study to agree upon timelines.
  • Leads planning and communication with cross-functional teams to ensure proper execution and conduct of the clinical trial; generates quality clinical data.
  • Serves as primary contact and resource for CRO and vendor personnel in overarching functions as well as team members in parent company.
  • Provides oversight and management of CROs, consultants and vendors.
  • Oversees and monitors the management of clinical studies ensuring they are conducted in compliance with the agreed study plans through regular CRO and/or investigator site contact.
  • Monitors progress of clinical activity and reports on the progress of assigned clinical trials including budget and timelines.
  • Monitors the status of clinical data collection of assigned clinical trials.
  • Prepares potential investigator site lists and assists with their evaluation for inclusion in the study.
  • Prepares and reviews study-related documents when required.
  • Reviews and approves study-related plans generated by CROs and vendors, and ensures the documentations are in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies.
  • Participates in the review and finalization of clinical study-related documents such as protocols, protocol amendments, clinical study reports (CSRs), regulatory submissions and other publications as required.
  • Participates in meetings – i.e. Study Team Meetings, Investigator Meetings, Monitors’ workshops and CRO Training.
  • Reviews correspondences and monitoring reports relating to the studies.
  • Prepare and deliver program/study updates.
  • Coordinates the delivery of clinical trial supplies in collaboration with CRO and other team members.
  • Monitors budget for clinical study, and review budgets and contracts with CROs, vendors and investigator sites (as applicable) in collaboration with Finance and Legal team.
  • Requests and critically evaluates proposals and change orders from CROs, vendors and investigator sites (as applicable).
  • Provides input into contracts, work orders and/or change orders.
  • Manages escalation of study related issues and communicates as appropriate with management and other R&D functions.
  • Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight.
  • Ensures assigned studies adhere to all applicable regulations and requirements.
  • Provides input as the subject matter expert for the assigned studies during regulatory inspections.
  • Establish collaborative and productive relationships with parent company, internal/external partners and relevant affiliates.
  • Evaluates issues found in clinical studies, communication and oversight of CROs and vendors, and suggests and implements solutions and mitigations as required.
  • Evaluate CRO and vendor performance and support the improvement initiatives.
  • Participate in the preparation, review, updating and training of SOPs.
  • Maintain knowledge of oncology therapeutic area, current medical practice and pharmaceutical regulations in order to ensure best practice across all activities.


Qualifications/ Requirements:
  • B.S./M.S./Ph.D. in a related life science discipline is preferred.
  • Thorough understanding of the oncology arena.
  • Minimum of five years of industry experience in clinical drug or program development or equivalent academic experience in clinical trials.
  • Strong experience facilitating project team meetings, cross-functional communication and decision making, and ensuring alignment with internal and external stakeholders
  • Strong attention to detail and the ability to establish priorities, schedule and meet deadlines.
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Thu, 30 Nov 2017 00:00:00 EST 0
<![CDATA[Regulatory Affairs Project Manager]]> My client is seeking a Regulatory Affairs Project Manager. The ideal candidate will provide project leadership and overall coordination for regulatory filings.  This role will collaborate cross-functionally to create and manage regulatory operational project plans.   This position reports to the Sr. Vice President of Regulatory Affairs and Quality.

Job Responsibilities:
  • Develop detailed project plans for regulatory submissions
  • Work with team(s) to draft plans, define content, assign project responsibilities, determine project timelines and ensure senior management review and approval
  • Manage regulatory affairs project meetings, obtain updates from various team members in order to track progress being made against timelines, notify management of critical issues and update timelines/database as appropriate
  • Participate in cross-functional development team meetings
  • Manage the completion of action items and drive the resolution of issues


Qualifications/Requirements: 
  • Bachelor’ s degree required, Master’ s degree in scientific discipline preferred
  • 8+ years of regulatory affairs experience in the pharmaceutical industry
  • Extensive hands-on experience and successful track record with regulatory submissions (IND’ s, CTA’ s NDAs, CTDs/eCTDs) required
  • Knowledge of regulatory processes, guidelines, regulations, submission/registration types and requirements and GxPs (GCPs, GLPs, GMPs)
  • Strong collaboration and verbal/written communication skills
  • Proven ability to manage projects and timelines and organize/track complex information
  • Highest ethical standards and focus on quality and details
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Thu, 30 Nov 2017 00:00:00 EST 0
<![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, 29 Nov 2017 00:00:00 EST 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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Mon, 20 Nov 2017 00:00:00 EST 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;
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Fri, 17 Nov 2017 00:00:00 EST 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.
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Thu, 16 Nov 2017 00:00:00 EST 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, 09 Nov 2017 00:00:00 EST 0
<![CDATA[Accounting assistant/ Collections]]> Job Responsibilities:
  • Compile the Unbilled Report and contact carriers to research, resolve, and retrieve missing documentation for invoicing.
  • Research, track, and restore accounting or documentation problems and discrepancies.
  • Research and analyze prior to initiating debtor contact, examines historical data, evaluates past collections efforts.
  • Provide customer service regarding collection issues, review account adjustments, and resolve customer discrepancies and short payments.
  • Contact customer(s) and establish reason for past due account situation; make arrangements for payments to bring account current and follow up to ensure obligation is satisfied.
  • Accountable for reducing delinquency for assigned accounts.
  • Enlist the efforts of sales and senior management when necessary to accelerate the collection process.
  • Establish and maintain effective and cooperative working relationships with customers.
  • Recommends accounts to be turned over to collection agencies.
  • Comply with all federal and state laws dealing with debt collection and the Fair Debt Collections Practices Act.


Qualifications/  Requirements:
  • Previous experience with soft collections
  • Professional communication and phone skills
  • Developed customer service skills
  • Ability to prioritize and multitask
  • Good verbal and written communication skills
  • Able to work in team environment
  • 3-5  years of general accounting and collections experience
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Mon, 06 Nov 2017 00:00:00 EST 0
<![CDATA[Receptionist/Executive Assistant]]> Individuals and businesses that partner with this organization are diverse and often have complex needs. As an Executive Assistant/Receptionist, you will play an integral role with the entire organization, particularly the Sales and Management Team. You will work under the direction of the President & CEO primarily but also substantively with the Chief Operating Officer. The ideal candidate will have a strong background as an Executive Assistant so as to enhance the executives' effectiveness by providing critical support and representing the executives to others.

You need to be proactive, able to multi-task in a fast-paced environment, and Client Service focused to help maintain good Client relationships both externally and internally.

Job Responsibilities
  • Support President & CEO on a daily basis; producing information by procuring, formatting, inputting, editing, copying, scanning, and transmitting information of all types
  • Optimizing executives' time by reading, researching, and routing correspondence; drafting letters and documents, collecting and analyzing information as well as initiating telecommunications
  • Maintaining President & CEO' s appointment schedule by planning and scheduling meetings, conferences, teleconferences and travel
  • Reviewing and commenting on Salespersons' monthly expense reports
  • Attending Sales Strategy Team Meeting (SST) every month, taking notes and transcribe notes into a report, attending other meetings as scheduled
  • Following-up with Producers on Sales Track Program
  • Maintaining and completing insurance carrier appointment requirements
  • Maintain and keep track of licensing for President & CEO
  • Welcoming guests and customers by greeting them, in person or on the telephone, answering or directing inquiries

Receptionist Duties:
  • Greet and direct visitors to appropriate staff (after calling to advise of, and identify visitor)
  • Answer incoming calls
  • Take and promptly deliver clear, concise messages when required
  • Page when necessary & Greet Clients, Vendors, etc.
  • Enter Client, Vendor and Carrier Business Cards in Microsoft Outlook
  • Send for Messenger Services, sign for delivery of packages
  • Update directories:  Telephone listing, Team Divisions, Anniversaries, Birthdays
  • Route faxes
  • Sort and distribute all incoming mail for Alper Team Members, and date stamp incoming and outgoing mail


Qualifications/ Requirements:
  • Education:  College Degree preferred or equivalent work experience.
  • Experience:  3-5 years’ administrative support in business environment or other related services industries required.

Preferred Qualifications: 
  • Discretion and confidentiality
  • Exemplary planning and time management skills
  • Ability to prioritize and multi-task efficiently
  • Ability to work effectively under pressure to meet deadlines
  • Extensive written and verbal communication skills
  • Ability to work in Team setting
  • High energy level
  • Good interpersonal skills
  • Must be flexible and work independently
  • Working knowledge of Microsoft Word, Excel, Outlook and Power Point
  • Experience with AMS360 or similar agency management system
]]>
Fri, 03 Nov 2017 00:00:00 EDT 0
<![CDATA[Senior Regulatory Specialist]]> We currently have an opportunity for a Sr. Regulatory Specialist who will be responsible for the on-time filing of high-quality regulatory submissions and for post-approval maintenance of regulatory dossiers.  Interacts with project teams and regulatory agencies in relation to submissions and other relevant topics.  Trains new regulatory specialists.  You will report to a Manager of Regulatory Affairs.  This position has no direct reports.

Job Responsibilities:
  • Representing RA on project teams and providing regulatory guidance
    • Serves as a role model for effectively communicating with individuals in different functions and at different levels
    • Shares expert knowledge of complex issues
  • Reviewing technical documents for cGMP and regulatory compliance
    • Shares expert knowledge of complex technical concepts
    • Trains and coaches others in regulatory requirements
  • Preparing and filing high-quality submissions to regulatory authorities (A/NDA’ s, Supplements, Amendments, Annual Reports and DMF Updates)
  • Communicates importance of quality assurance
  • Develops quality standards for RA
  • Provide regulatory decisions with regard to acceptability of submission documents and decisions
  • Develops and brainstorms regulatory strategy and options for resolving complex and difficult issues that could result in project termination if not addressed
  • Filing all applications in accordance with predetermined timelines
    • Shares with others best practices for planning, organization and time management
  • Representing the company with regulatory agencies and industry groups as applicable
    • Uses persuasive communication to influence regulatory agencies
  • Train new regulatory scientists on RA and company systems
  • Mentor regulatory scientists regarding the regulations
    • Provides comments and perspective on proposed regulations
  • Working effectively in a team environment to ensure not only individual tasks are accomplished, but that team and department objectives are achieved.
    • Draws out underlying team conflicts and facilitates agreement among team members
    • Actively seeks ways to improve team processes and areas for improvement
    • Dedicates time and energy to remove obstacles to facilitate achievement of team goals
  • Ensuring that supervisor is aware of activities and progress
  • Projecting professionalism and a courteous, cheerful and cooperative demeanor
    • Maintain ongoing relationships with multiple customers as a trusted advisor
  • Other duties as assigned


Qualifications/ Requirements:
  • At minimum, a Bachelor Degree in a scientific discipline and a minimum of 4 years’ experience in pharmaceutical Regulatory Affairs.
  • Experience in preparing and filing complete A/NDA' s, Supplements, Amendments and Annual Reports to FDA.
  • Thorough understanding of the CFR, FDA/ICH guidelines and cGMP' s as they pertain to pharmaceuticals.
  • Well-developed communication skills.  
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Mon, 30 Oct 2017 00:00:00 EDT 0
<![CDATA[Senior Regulatory Affairs Specialist]]> Responsible for establishing regulatory strategies for assigned product lines with appropriate supervisory approvals. Prepare submissions for assigned Automated Blood Technology projects world-wide. Responsible for on-time filing of high-quality regulatory submissions for new products, changes and compliance activities. Participate on multi-functional project teams and act as global regulatory advisor. Represent Regulatory on complex core teams. Able to operate independently with limited supervision.

Job Responsibilities:
  • Represent regulatory on assigned product and project teams and establish regulatory strategies that align with world-wide objectives.
  • Execute regulatory plans for complex projects. Develop and execute project plans for change control, new registrations and maintenance of existing licenses world-wide.
  • Keep apprised of global regulatory requirements and inform product teams of upcoming changes in the regulations.
  • Provide assistance with responses to regulatory agency questions.
  • Review and approve product labeling and advertising for compliance to applicable regulatory requirements.
  • Review technical documentation for suitability to support regulatory filings with regard to content, quality and clarity.
  • Act as regulatory project manager on assigned projects. Interact with subject matter experts to help ensure on-time, quality documentation for regulatory filing. Drive to expected regulatory timelines.
  • Provide regulatory expertise and technical knowledge to fulfill complex post-market requirements.
  • Act as liaison for Business Unit RA to Country RA interactions


Qualifications/ Requirements:
  • Experience in preparing and filing complete 510(k) applications to FDA
  • Thorough understanding of the CFR, FDA/ICH guidelines and cGMP’ s, as they pertain to medical devices.
  • Excellent communication and writing skills in the English language.
  • Proficiency in using Microsoft Office software tools including Word, Excel, and Powerpoint.
  • Ability to manage multiple projects and deadlines and communicate conflicts of priorities.
  • 5 years regulatory affairs or equivalent experience within a medical device/pharmaceutical company, CRO, or similar organization.
  • Bachelor’ s degree in a scientific discipline or engineering preferred.

 
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Mon, 30 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[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
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Mon, 02 Oct 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.
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Thu, 21 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
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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
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Thu, 07 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
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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
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Fri, 25 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
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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
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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
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Tue, 25 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.
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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
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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
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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%
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Thu, 06 Jul 2017 00:00:00 EDT 0