<![CDATA[The Steely Group: jobboards]]> http://JOBS.THESTEELYGROUP.COM/ en-us <![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
]]>
Fri, 23 Feb 2018 00:00:00 EST 0
<![CDATA[Clinical Research Coordinator]]> Incumbent will have diverse responsibilities including clinical research representation on product development, preclinical research development, implementation and management, assimilating medical information to key opinion leaders and other healthcare professionals in the role of clinical science liaison, scientific/medical communications including development of publication strategies, drafting and submitting abstracts, posters, and manuscripts in as well as presenting research study findings.

Job Responsibilities:
  • Incumbent will develop and manage the scientific communications and be responsible for overseeing all abstracts, posters and manuscripts created within the division as well as the physician-initiated study reports.
  • Key accomplishments in role should include:
  • Create and submit publications ranging from the most complex and innovative interventional pain management procedures
  • Strategic alignment of publications within business initiatives
  • Significantly increase the number of published manuscripts created within the practice


Qualifications/ Requirements:
  • Exposure to Pain Management and publications within therapeutic area high priority for practice. 
  • Must submit and write approx. one case report per month- will have access to EMR, patients and doctor. 
  • Team has 3 MD’ s, 1 NP and staff. 
  • Prefers candidate with PhD or post doc work. 
  • Average of 7-10 projects to work on, 4-5 case reports and 2 studies.
]]>
Fri, 23 Feb 2018 00:00:00 EST 0
<![CDATA[Associate Director/Director Regulatory Affairs, CMC]]> Our client is looking for an Associate Director/Director Regulatory Affairs, CMC. They will lead the CMC regulatory strategy and processes for assigned programs to significantly contribute in driving the development of our assets forward.

Job  Responsibilities:
  • Acting as the primary CMC regulatory representative on selected programs to develop CMC regulatory strategies, submissions and compliance activities
  • Managing CMC regulatory activities and timelines
  • Developing the strategy for meetings with regulatory authorities addressing necessary CMC requirements
  • Leading the planning and preparation of the CMC sections of global regulatory submissions
  • Collaborating with the greater CMC teams to provide regulatory guidance
  • Developing and maintaining regulatory knowledge of US, EU and ROW regulations
  • Performing literature searches, preparing special reports and assembling documentation to support project teams
  • Assisting in the development and maintenance of departmental processes, policies, SOPs and associated documents
  • Participating in initiatives aimed at improving internal departmental standards and systems


Qualifications/ Requirements:
  • Minimum of 8 years of experience in a biotech and/or pharmaceutical environment, including 4-5 years of Regulatory CMC experience
  • Minimum requirement of a Bachelor’ s Degree in a scientific discipline or equivalent
  • Experience with biologics program from development through registration
  • Experience in interacting and meeting with regulatory agency personnel on CMC related topics (e.g FDA, EMA etc.)
  • Experience in compiling and reviewing CMC sections of regulatory submissions (INDs, IMPDs, CTAs, BLAs, MAAs, etc.)
  • Knowledge of: drug development; FDA, EMA and ICH CMC guidelines and regulations; current Good Manufacturing Practices (cGMP)
  • You must be a team player that can handle multiple tasks simultaneously in a fast growing company
  • Possess outstanding verbal and written communication skills
]]>
Thu, 22 Feb 2018 00:00:00 EST 0
<![CDATA[Manager/Sr. Manager, GCP Quality Assurance]]> The Manager/Sr. Manager GCP Quality Assurance, is responsible for monitoring and evaluating the compliance of clinical studies and client oversight of studies to FDA and International regulations and guidelines, as well as corporate policies and standard operating procedures.

Job Responsibilities:
  • Plans, conducts and reports on GCP audits of clinical investigators, vendors and systems plus key reports and documents
  • Participates in cross-functional teams providing guidance and risk based options
  • Reviews study documents and checks for consistency and appropriate standards and practices
  • Supports the internal audit process with regards to documents and compliance
  • Provides support during regulatory inspections and internal audits
  • Assists in the creation and maintenance of audit tools
  • When appropriate, prepares and/or revises GCP SOPs and Work Instructions
  • Represents GCP QA on appropriate teams to facilitate audit planning
  • Supports comprehensive internal GCP training programs
  • Works with cross-functional teams to provide GCP advice
  • Receives guidance from GCP QA senior colleagues and management
  • Coordinate audits, including external vendors, trial master file, clinical investigator sites, clinical documents and other internal systems.
  • Maintains and track Clinical CAPAs to ensure timely CAPA activities remediation and completion.
  • Maintain a work environment focused on quality, fostering respect, open communication, collaboration and teamwork.
  • Maintains good working relationships and communication with GCP customers and GxP QA audit staff
  • Partner with the Clinical Department, Drug Safety, Supply Chain and Commercial Operations to ensure all clinical trials are assessed for compliance with SOPs, FDA and other applicable regulations, and ICH/GCP guidelines.
  • Ability to travel up to 30% per month
  • May be required to perform additional duties as needed


Qualifications/ Requirements:
  • BS/BA degree in a scientific or health-rated field.
  • Professional work experience in Quality environment with hands-on experience related to clinical trials.
  • Manager Level;   Minimum  6 years of progressive experience quality assurance in the   pharmaceutical and/or biotechnology industry
  • Sr. Manager Level:  Minimum 8 years of progressive experience quality assurance in the  pharmaceutical and/or biotechnology industry
  • Knowledge of applicable FDA, EU and ICH regulatory requirements for GCP and GLP.
  • Experience working with clinical trial pharmaceutical regulations and guidance
  • Experience with internal and external audits of clinical studies, vendors, data and reports is strongly preferred but not required (training provided)
  • Understanding of regulatory inspection processes is strongly preferred but not required (training provided)
  • Understands Clinical SOPs, department controlled documents, Trial Master File, GCPs and regulations
  • Knowledge of drug development, study design, data and trials management, procedures and documentation practices
  • Flexible and able to work in a fast paced environment while handling multiple demands with shifting priorities
  • Demonstrates effective interpersonal skills and independent problem solving capabilities
  • Coordinates projects to successfully meet timelines
  • Possesses strong analytical skills and attention to detail
  • Excellent communication skills, able to present complex information clearly and logically
  • Proficient in word processing, spreadsheets and database software applications on a PC, specifically MS Office: Word, Excel and PowerPoint
]]>
Thu, 22 Feb 2018 00:00:00 EST 0
<![CDATA[Medical Writer]]> The medical writer will be a key member of the Project Team and will work closely with Research, Clinical Operations and Regulatory Affairs to manage all aspects of document preparation for clinical and regulatory documents according to company guidelines and international governmental regulations. S/he will provide strategic direction to cross-functional teams to ensure that key messages are consistently aligned with reporting requirements and company objectives.

Responsibilities 
  • Plan, prepare, write, edit, format, and finalize non-clinical, clinical and regulatory documents. Documents will include, but are not limited to: IND, CTA, non-clinical summaries, clinical protocols, clinical study reports, Investigator brochures, updates to regulatory submissions, annual reports/development safety update reports (DSURs) etc.
  • Assist in developing strategy for organizing and preparing documents for regulatory health authority submissions.
  • Coordinate the internal review of documents.
  • Develop, maintain, and drive document finalization timelines.
  • Ensure final document adheres to standard operating procedures (SOP), good clinical practice (GCP), and the International Council on Harmonisation (ICH).
  • Perform quality control review of medical writing documents
  • Assist in the development of templates, style guidelines, and SOPs for clinical documentation

Requirements
  • Minimum requirement of a bachelor’ s degree with 3-5 years of medical writing experience in a pharmaceutical/biotechnology or CRO environment
  • Ability to interpret and present clinical and non-clinical data objectively in a clear, concise format.
  • Outstanding written and oral communication skills
  • Proficiency in teamwork, organization, and project management
  • Proficiency in MS Office; experience using electronic document management system

 
]]>
Wed, 21 Feb 2018 00:00:00 EST 0
<![CDATA[Manager/Sr. Manager, Medical Writing]]> As an integral part of the clinical team, the Sr. Manager/Manager of Medical Writing develops Clinical and Regulatory documents, ensuring the documents are of high quality and comply with internal and external standards. The Sr. Manager/Manager of Medical Writing should be able to contribute insight to the analysis of data and advise the team on strategic presentation of results/information to ensure clear communication with external readers. The Manager of Medical Writing will be an integral team member of registration dossiers, contributing to the development of Module 2 summary documents.

If the incumbent will be working in a remote capacity, the requirement is that they work on site in Cambridge, MA for the first week of employment, followed by working onsite 2-3 days every other month.

Job Responsibilities:
  • Plan, prepare, write, edit, format, and finalize clinical and regulatory documents. Documents will include, but are not limited to: clinical protocols, clinical study reports, Investigator brochures, Module 2 summaries of registration dossiers, annual updates to regulatory submissions, briefing books, risk management plans, and regulatory responses.
  • Coordinate the internal review of documents.
  • Effectively collaborate with Clinical Research and Development colleagues, along with other departments including, but not limited to, regulatory, safety, biostatistics, clinical operations, biology, medical affairs, and the commercial group.
  • Represent Medical Writing on project teams and, as such, advise teams on content and format requirements for various documents, as well as coordinate writing activities for document development (e.g., timelines and review/revision responsibilities) with the project teams.
  • To ensure compliance, remain informed on regulations and developments in medical writing, as well as maintain knowledge of product areas, current trends, and current literature.


Qualifications/ Requirements:
  • Ph.D. or similar advanced degree in a relevant scientific field
  • 4+ years of industry experience as Medical Writer
  • Experience in Psychiatry/Neurology/Oncology therapeutic areas
  • NDA experience with active contribution in planning and preparation of summary documents
  • In-depth experience in US and Non-US Regulatory submissions
  • Experience in working with cross-functional teams
  • Excellent interpersonal and communication skills
  • Flexibility/adaptability to work in a fast-paced and dynamic environment
  • Candidates must be authorized to work in the U.S.
]]>
Wed, 21 Feb 2018 00:00:00 EST 0
<![CDATA[Senior Manager/Associate Director, Program Management]]> Our client is seeking a Sr. Manager/Associate Director, Program Management.

This is an opportunity for a versatile individual to become an integral member of the R&D and business teams, contributing to the program management function as a key value driver. This person will play an instrumental role in organizing and advancing critical R&D programs, facilitating timely and impactful decisions, and establishing and contributing to the development of overall program and portfolio strategy. My client is an early-stage company so this position will offer visibility while assisting to build out the function as well as the opportunity to present to senior leaders within the organization.

Job  Responsibilities:
  • In partnership with the project leaders, guide program strategy, set program goals and lead team decision-making for discovery and early development programs
  • Lead program management activities, including program planning and milestones tracking, meeting management/minutes, and internal reporting
  • Ensure coordination of activities and deliverables across all functions
  • Develop and implement program management best practices and associated tools
  • Collaborate cross-functionally to develop and manage the R&D budget, including resource tracking and scenario planning
  • Manage CROs and other vendors, as appropriate


Requirements:
  • 5-8 years of relevant biotech and/or pharmaceutical industry experience is required. Antibody development experience would be a plus
  • MS or PhD in the sciences preferred, with a minimum of a BS/BA required
  • At least 2-3 years in program/project management is required
  • Experience managing projects across discovery and preclinical programs; experience leading cross functional activities through IND submission preferred
  • Operational experience and familiarity with the drug development process, including function-level activities and external regulatory requirements
  • Experience setting and maintaining budgets
  • Ability to influence across multiple functions, effectively work with different personalities and styles, and efficiently prioritize activities
  • Excellent communication skills; comfortable navigating complexity and ambiguity in a fast-paced environment
  • Knowledge of project management tools (Microsoft Project, Excel, PowerPoint)
]]>
Wed, 21 Feb 2018 00:00:00 EST 0
<![CDATA[AD/Director, Regulatory Affairs CMC]]> Director, Regulatory CMC Affairs

Reporting to the Senior Director of Regulatory CMC, this position will provide support for Chemistry Manufacturing and Controls (CMC RA) for development and marketed products. This position will provide product strategy and direction to commercial and clinical teams. Incumbent will be responsible for assuring the regulatory strategy is aligned with Health Authority requirements from a global perspective and assuring that regulatory submissions are on time and high quality. Experience working in a matrix environment and excellent people skills are required.

Responsibilities:
  • As a member of the project teams, provide strategic CMC regulatory guidance for global development and registration programs (eg. INDs, CTAs, NDAs and MAAs)
  • Assess and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines
  • Primary regulatory representative (for assigned projects) at internal meetings as well as at meetings with regulatory agencies for all CMC related issues
  • Compile, review, approve and submit CMC and marketing registration applications, supplements and variations. Writing appropriate section of the Module 3 and 2(relevant sections only) and responding to regulatory questions from various regulatory authorities, working in collaboration with SME’ s in Tech Ops, QC/QA, global supply chain and other business partners .
  • Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
  • Manage contract staff and vendors as needed to support regulatory activities.

 

Requirements:
  • Advanced scientific degree preferred. B.A./B.S. or higher degree (s) in the sciences, or health related field minimum, with 10- 15 years regulatory experience.
  • Experience of successful INDs, NDA and/or BLA filing(s) is essential
  • Established working knowledge of regulatory guidelines and regulations (US and international).
  • Regulatory experience supporting both development projects and marketed products.
  • First-hand knowledge and experience of FDA CMC regulatory submissions is essential
  • Strong knowledge of eCTD elements and structure and regulatory writing skills
  • Possesses strong written and verbal communication and presentation skills.
  • Experience working with all levels of management and consulting with key business stakeholders.
  • Strong team player that has a customer service approach and is solution oriented.

 
]]>
Tue, 20 Feb 2018 00:00:00 EST 0
<![CDATA[Inside Sales Representatives]]> Our client, a leader in metals distribution and fabrication, is currently seeking Inside Sales Representatives to join their customer service center sales team in Minneapolis, MN. Under the supervision of the Inside Sales Manager, the  primary role as an Inside Sales Representative is to provide sales support across company-wide markets in order to achieve sales growth. You will  provide  excellent service while interacting with customers over the phone and through email. Inside Sales Representatives are responsible for direct sales aimed toward growing the  business overall.  

Job Responsibilities:

• Collaborates  with a variety of industries while promoting transactional and fabrication sales business
• Builds professional relationships with customers across multiple geographic markets
• Responds to customer quotation requests, needs, inquiries, and complaints/concerns
• Generates sales through focused, pro-active marketing; primarily out-reaching
• Processes customer orders (i.e. quotations and order entry)
• Sources for items that are not stocked
• Identifies strategies to improve/grow sales
• Understands and incorporates the goals and concepts of our business to grow sales and profitability
• Works closely with territory managers, credit, inventory, warehouse operations, and other departments within the company
• Performs other duties as assigned

  Requirements:

• Associates Degree and 1-3 years of sales or industry experience
• Previous sales or customer service experience preferred
• Proficiency with Microsoft applications (i.e., Word, Excel)
• Attention to detail
• Ability to skillfully multi-task
• Results-focused, competitive, and self-motivated attitude
• Problem solving/conflict resolution and negotiation skills
• High level of numerical and mechanical aptitude
• Takes ownership of work; understands the importance of creating value/recognizes opportunities
• Ability to work well and excel while working with a team or individually
• Strong interpersonal, written and verbal communication skills

 
]]>
Mon, 19 Feb 2018 00:00:00 EST 0
<![CDATA[Sr. Medical Director, Pharmacovigilance]]> Senior Medical Director, Pharmacovigilance

My client is looking for an experienced Sr. Medical Director/Medical Director of Drug Safety and Pharmacovigilance (DS&PV) that is a creative, resourceful and integrative thinker. The Sr. Medical Director/Medical Director serves as the global lead for the pharmacovigilance and risk management of assigned investigational and/or marketed products.   This is a highly visible role that will interface across all levels of management and functional areas and is responsible for identification of safety signals, signal investigation and the proactive management of the benefit-risk profile for assigned products. Effective communication skills will be key as this role provides an excellent opportunity for close collaboration with colleagues from other functions such as Clinical Development, Clinical Operations, Regulatory Affairs and Medical Affairs.

 

Responsibilities:
  • Lead product safety surveillance activities for assigned product(s)during all phases of the product life-cycle
  • Maintain knowledge of therapeutic area diseases and assigned product(s) safety and efficacy profile
  • Ensure that routine signaling activities assessment and investigation are completed and documented per SOPs
  • Respond to safety-related queries from regulatory authorities, IRBs/ECs
  • Lead product benefit-risk assessment discussions at Safety Governance Committee
  • Includes needed actions to update Reference Safety Information or risk minimization actions
  • Lead DS&PV representation for clinical development of the assigned product(s) including:
  • Clinical development plans, protocol development (inclusion/exclusion criteria, collection and monitoring of safety data), statistical analysis and reporting of study data
  • Safety content of IB, Reference Safety Information, ICF
  • Regulatory filings (ISS, Benefit-Risk, RMP/REMS as required)
  • Responsible for medical-safety sections of aggregate safety reports (DSUR, PSUR)
  • Conduct medical review of individual case safety reports (ICSRs)
  • Includes appropriate follow-up requests and accuracy and timeliness of expedited reports
  • Assisting in the successful implementation, execution and maintenance of safety processes and systems that conform to the company’ s business strategy, industry standards and compliance with global regulations

Requirements:
  • MD, MD PhD or MD MPH required
  • Minimum of 3-7 years’ experience in drug safety and/or clinical research/clinical safety experience in the pharmaceutical industry
  • Sound clinical acumen and decision making
  • Ability to review, synthesize and analyze and communicate (verbally and in writing) complex safety data and clinical/pharmaceutical information
  • Expertise in international regulations governing drug safety (US and EU) for pre and post-marketing
  • Level will be commensurate upon experience and qualifications.
  • Prior experience contributing to the development (process improvement, training, etc.) of a drug safety department would be desirable

 
]]>
Mon, 19 Feb 2018 00:00:00 EST 0
<![CDATA[Principal Medical Writer - Remote]]> The Principal Medical Writer is responsible for providing scientific publications or 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 (e.g. PK, Toxicology, eSubmissions, Regulatory, Statistical Support, Data Management, Clinical, Publishing) to ensure accurate and timely completion/delivery of information and review of scientific publications or clinical regulatory submissions. Serves as the scientific writing content expert for the department.

Job Responsibilities:
  • Serves as medical writing lead on more complex scientific publications or clinical regulatory documents such as those associated with filings and dossiers. Works closely with the Publications or Regulatory team(s) on document strategies. Implements all activities related to the preparation of scientific publications (e.g. abstracts, posters/oral presentations, manuscripts) or to the preparation and compilation of data and information into a single comprehensive package for new and updated clinical.
  • Serves as a subject matter expert within department for assigned therapeutic/product areas. As assigned, provides direction and guidance to medical writers regarding assigned projects, including review of work product. Provides input and feedback to management regarding internal medical writers' work product/quality. Recognizes potential scheduling and resource conflicts for projects across therapeutic area/product assignments and provides recommendations to resolve.
  • Converts relevant data and information into a form that meets clinical regulatory document requirements. Explains data in manner consistent with the target audience(s), journal/congress requirements, and/or clinical regulatory requirements. Coordinates the review, approval, and other appropriate functions involved in the production of scientific publishing or clinical regulatory projects. Arranges and conducts review meetings with the team. Ensures required documentation is obtained.
  • Responsible for effective communication among team members. Communicates deliverables needed, writing process, and timelines to team members. Holds team members accountable to agreed-upon project dates. Negotiates with functional areas on project outcomes and deliverables to meet conflicting demands (time, deliverables, etc.). Must identify and resolve conflicts (including document content issues), remove barriers, generate innovative ways to ensure teams achieve project goals. Ensures all.
  • Understands, assimilates, and interprets sources of info with appropriate guidance/direction from product teams and/or authors. Interprets and explains data generated from a variety of sources, including internal/external studies, research documentation, charts, graphs, and tables. Verifies that results are consistent with protocols. Confirms completeness of info to be presented. Challenges conclusions when necessary. Independently resolves document content issues and questions.
  • Understands/complies with appropriate conventions, proper grammar usage, and correct format requirements per journal/congress, ICH and other governing bodies following applicable divisional guidelines, templates, and SOPs.
  • Performs literature searches as needed for drafting document content. Interprets literature information and makes recommendations for application to scientific publications or clinical regulatory documents.
  • Works with Regulatory Quality Assurance throughout clinical regulatory document audit process, answers questions during the audit process (as appropriate), and works with team to draft responses as necessary.
  • Maintains expert knowledge of US and international regulations, requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions. Advises teams regarding compliance with scientific publications or clinical regulatory document content as defined in journal/congress guidelines or regulations, respectively. Learns and applies knowledge of therapeutic area and product to scientific publishing projects. Must continually train/be compliant with.
  • Serves as a department representative on project teams. Acts as Subject Matter Expert for assigned clinical teams regarding computer-based technologies utilized by the respective departments (e.g. eDocs, eCTD, journal/congress databases).Coaches, mentors, and assists medical writers. Provides guidance to non-Abbott medical writers and external vendors/agencies. Recommends, leads, and implements tactical process improvements, both within the department and division-wide.


Qualifications/ Requirements:
  • Bachelor of Science required, with significant relevant writing experience, or Bachelor' s degree in English or communications, with significant relevant science experience. 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.
  • 4 years 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.
  • 2 years relevant industry experience preferred.
  • 4 years experience in experimental design and clinical/preclinical data interpretation preferred.
  • High-level content writing experience and experience with all types of clinical publications or clinical regulatory documents required. Expert in assimilation and interpretation of scientific content with adeptness in ability to translate for appropriate audience. Working knowledge of statistical concepts and techniques.
  • 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. Superior attention to detail. 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.
]]>
Mon, 19 Feb 2018 00:00:00 EST 0
<![CDATA[Manager, Medical Publications and Communications]]> Our client is seeking a Manager, Medical Publications and Communications. The successful candidate will be responsible for interacting with various investigators, HCPs, vendors, and internal departments to lead publications planning and management for assigned therapeutic area(s) while ensuring compliance with good publication practices and scientific merit of medical publications.

Job Responsibilities:
  • Work with internal and external authors in actively facilitating the development of abstracts, posters, presentations, original manuscripts, and review papers.
  • Lead cross functional strategic publications efforts in alignment with product development teams to ensure prioritized submission and publication of data to address unmet educational needs.
  • Coordinate medical writing and external vendor activity to ensure timely delivery and submission of publications.
  • Ensure consistent adherence to established publication process in accordance with good publication practices.
  • Manage assigned publications spend to ensure accurate accounting and reconciliation to available budget.
  • Collaborate with functions inside and outside of Medical Affairs to translate available data and publications into medical communications and educational resources.
  • Partner with Congress Strategy lead and conference planning team to map out oral and poster presentations.
  • Cover poster and scientific sessions at select medical conferences and write debriefs.


Qualifications/ Requirements:
  • This position requires a clinical and scientific background and significant biotechnology/pharmaceutical industry experience in leading publications efforts in a highly matrixed organization.
  • 5+ years in a biotechnology/pharmaceutical environment required.
  • Has attention to detail, excellent communication and project management skills, and proven ability to effectively collaborate and influence decision-making across multiple levels of an organization, including senior leadership.
  • Willing and able to travel for medical conferences as necessary.
]]>
Fri, 16 Feb 2018 00:00:00 EST 0
<![CDATA[Associate Director, Clinical Operations]]> The Associate Director, Clinical Operations is responsible for the planning, implementation and conduct of clinical trials in Phase I/II.    The Associate Director, Clinical Operations is accountable for the day-to-day operations of clinical trials including, but not limited to, feasibility, study start up, enrollment and close out activities.  The Associate Director, Clinical Operations will manage the clinical project team members to ensure adherence to overall project timelines and budget. 

Job Responsibilities:

Clinical Trial Management
  • Serve as the clinical point person managing protocol execution, including the oversight of  CROs, vendors and consultants that are involved with the clinical trial
  • Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines.
  • Ensure study team adherence to ICH/GCP/Federal and local regulations and company specific SOPs.
  • Responsible for ongoing study communication and escalation of study-related issues as required.
  • Participate in program strategy meetings, ad hoc clinical operations’ initiatives and programs.
  • Assist in preparation and review of clinical documentation such as informed consent, clinical protocols, Investigator Brochure, Clinical Monitoring Plan, Project Plan.
  • Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic reviews. 
  • Assist with the development of the clinical components of regulatory submissions including, but not limited to: safety, interim and final study reports.
  • Participate and respond to Quality Assurance and/or regulatory authority inspection audits.

Fiscal and Contracts Management
  • Participate in request and review of scope of work, budgets, vendor performance and issue resolution.
  • In conjunction with legal group, facilitate the development of clinical trial agreements and other relevant documents.
  • Manage clinical trial budgets, providing ongoing financial reporting and projections to finance group.

Cross-Functional Mentoring and Leadership
  • Work cross-functionally to ensure clinical program timelines and goals are met.
  • Provide study-specific mentoring and line management for junior team members, as appropriate.
  • Participate in operational improvement initiatives (e.g. SOP development, training, etc.).


Qualifications/ Requirements: 
  • Bachelor’ s degree in health sciences or related field.
  • Minimum of 10+ years of experience in clinical research with at least 5 years of experience in early phase (I/II/III) clinical study management.
  • Experience in management of CROs, vendors and consultants.
  • Documented training, knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials.
  • Experience developing trial plans including site monitoring, risk mitigation strategies, trial budgets, site selection and clinical supply management.
  • Experience mentoring team members
  • Proficient written and verbal communication skills.
  • Ability to collaborate effectively with the study team, cross-functional team members and external partners (including investigator and site staff) using collaborative negotiation skills.
  • Strong computer skills including knowledge of Excel, Word, PowerPoint, Outlook and MS Project.
]]>
Fri, 16 Feb 2018 00:00:00 EST 0
<![CDATA[Associate Director, CMC Regulatory Affairs]]> Out client is seeking an Associate Director, Regulatory Affairs who will be responsible for CMC regulatory activities, strategies and submissions supporting the development and commercialization of current portfolio.

Job Responsibilities:
  • As a member of the program teams, provide strategic guidance on FDA and global regulatory requirements for clinical development and registration of small molecule pharmaceuticals.
  • Compile, review and approve CMC modules of development and marketing registration applications, amendments, and supplements for submission.
  • Development and implementation of CMC RA strategies for the earliest possible product approval and assistance with preparation for agency meetings.
  • Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
  • Serve as CMC regulatory lead at internal meetings as well as at meetings with business partners and regulatory agencies for all CMC related issues.
  • Assess and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines.
  • Collaborate with contract staff and vendors as needed to support regulatory activities.
  • Provide create and innovative solutions while being an advocate for compliance.


Qualifications/ Requirements:
  • 5+ years of experience in Regulatory Affairs related to development of pharmaceuticals with a minimum of 4 years in Chemistry, Manufacturing and Control (CMC) regulatory environment, CNS experience preferred
  • Bachelor of Science in a scientific discipline (Chemistry, Biochemistry, or related pharmaceutical science), advanced degree preferred.
  • Established working knowledge of regulatory guidelines and regulations (US and international).
  • Regulatory experience supporting both development projects and marketed products.
  • Strong knowledge of eCTD elements and structure and regulatory writing skills.
]]>
Thu, 15 Feb 2018 00:00:00 EST 0
<![CDATA[Associate Director, Quality Assurance (GCP/ GLP)]]> Our client is seeking an Associate Director, Quality Assurance (GCP/GLP). This person will be a creative, resourceful, integrative thinker for an important role that is responsible for GLP and GCP compliance and audit activities.

Job  Responsibilities:
  • Plan and lead GCP and GLP audits (international and domestic), including clinical investigator sites, contract clinical laboratories, and CROs to determine compliance status and identify compliance risks.
  • Assess GCP and GLP compliance risk areas and develop and implement risk mitigation measures.
  • Ensure compliance with company' s procedures and regulatory requirements.
  • Conduct QA reviews of project-related Clinical Development essential documents (e.g. protocols, amendments, case report forms, tables and listings, informed consents, investigator brochures, and Clinical Study Reports).
  • Review and provide input into non-clinical documentation (e.g. protocols, study reports).
  • Facilitate GCP/GLP training of functional areas and develop appropriate training for personnel involved in the execution of clinical trials and nonclinical studies.
  • Participate in the evaluation and selection of CROs and other clinical and nonclinical service providers.
  • Provide guidance, interpretation and information on GCP and GLP regulations, standards and quality systems.
  • Develop and implement standards, policies and procedures for GCP/GLP regulatory compliance.
  • Develop and measure quality metrics to drive consistent quality standards relating to GCP and GLP activities.


Qualifications/  Requirements:
  • Bachelor’ s degree with minimal 10 years’ experience in Biotech or Pharma and 5+ years’ experience in Quality Systems related to GCP and GLP.
  • Strong analytic skills with practical knowledge of how to identify key performance quality metrics to set targets for maintaining a state of compliance while identifying areas for improvement.
  • Extensive experience auditing clinical CRO’ s, clinical sites and investigator sites.
  • Understanding of domestic and international regulatory requirements.
]]>
Thu, 15 Feb 2018 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.
]]>
Wed, 14 Feb 2018 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
]]>
Wed, 14 Feb 2018 00:00:00 EST 0
<![CDATA[Clinical Research Outsourcing Manager]]> We are seeking a highly skilled Clinical Research Outsourcing Associate/Manager to assist with all aspects of the contract process from vendor selection through execution and close out of the contract.  As a member of the Clinical Operations team, you will be able to work alongside passionate and innovative team members who will support you in your role. 

Job Responsibilities:
  • Initiating and managing the Request for Proposal (RFP) process for clinical research and development vendors, including full-service CROs, central laboratories, specialty laboratories, ePRO, EDC and other Data Management providers, biostatistics and central imaging
  • Developing and negotiating SOWs and contracts with input from the clinical teams based on needs of protocol
  • Supporting any contract amendment required throughout the study
  • Reporting contract and budget status to management, responsible for oversight of Agreement Tracker
  • Working with the clinical teams to manage out of scope activities and change orders
  • Liaising with legal department to drive contract negotiations in timely fashion
  • Liaising with finance department to ensure they have information needed to provide accurate forecasts and accruals
  • Establishing relationships with vendors and serving as a key liaison with internal and/or external team members, regarding all contract related issues


Qualifications/ Requirements:
  • Bachelor’ s degree required
  • Minimum of 3 years in clinical research outsourcing and RFP management in a pharmaceutical, biotechnology and/or CRO organization
  • Demonstrated proficiency in management of multiple contracts for multiple clinical programs, budget tracking and ability to work with multiple departments
  • Extensive knowledge of clinical trials in all phases and clinical vendors, including CROs is essential
  • Experience with mid-study changes
  • Experience reviewing contract language
  • Extensive experience negotiating budgets with clinical vendors
  • Must have the ability to read and understand a protocol and determine outsourcing needs of a particular protocol
  • Knowledge of clinical outsourcing and familiarity with major vendors
  • Understanding of fair market value and how budgets are developed
  • Proficiency in MS Word and Excel is required
]]>
Wed, 14 Feb 2018 00:00:00 EST 0
<![CDATA[Director, Regulatory Affairs (Advertising & Promotion)]]> My client is seeking a creative, resourceful, strategic thinker for an important role that is responsible for overseeing the regulatory assessment of external communications regarding products; develop and review regulatory strategies for promotional materials for marketed and pipeline products; provide regulatory input to various functional units on promotional labeling for marketed and to-be marketed drugs, and serve as a the lead regulatory affairs representative on the oversight committees for our lead compound.

Job  Responsibilities:
  • Provide regulatory oversight of advertising and promotional activities for the Company’ s lead compound
  • Develop and implement strategies for achieving effective and compliant communications for commercially available products and investigational products.
  • Work collaboratively with cross-functional teams (stakeholders include Marketing, Medical Affairs, Legal, Compliance, R&D) from concept through approval, use and sunset to develop and review materials which are compliant with applicable regulations, guidelines, corporate policies and product development objectives.
  • Work collaboratively with cross-functional teams (Medical Science, Medical Affairs, Clinical Operations, Legal, etc) to ensure scientific and medical external communications are non-promotional and compliant with applicable regulations, guidelines corporate polices and product development objectives.
  • Oversee the compilation and submission of materials to Regulatory Authorities (e.g. OPDP) as applicable.
  • Correspond with Regulatory Agencies related to external communications for the Company’ s products.
  • Interact effectively with functional business units in order to coordinate and facilitate documentation required for submissions, ensuring that timelines are met.
  • Work collaboratively with Compliance to ensure that approved materials are used within the intended guidelines and duration of use.
  • Ensure that changes in US Package Insert are appropriately implemented and reflected in current promotions and advertising
  • Participate in training of sales and marketing personnel on promotion, marketing, labeling and advertising regulations.


Qualifications/  Requirements:
  • Bachelor’ s Degree (B.S.) and a minimum of five to seven years related experience in Regulatory Affairs-Advertising and Promotion; minimum of ten years of biotech/pharmaceutical experience in various applicable roles.
  • At least five (5) years of experience involving the direct implementation of promotional labeling and advertising regulations in the biotech/pharmaceutical/medical device industry; this must include extensive experience providing regulatory input and evaluation as part of a promotional review committee.
  • At least three (3) years in a team leadership role with highly effective people management skills
  • Current knowledge of FDA guidelines and regulations with an emphasis on product promotional activities.
]]>
Wed, 14 Feb 2018 00:00:00 EST 0
<![CDATA[Sr. Manager/Associate Director, Trial Master File]]> This position will provide the leadership, subject matter expertise and clinical study team support required to ensure that the electronic Trial Master File (eTMF) is managed in accordance with relevant ICH guidelines, GCP regulatory requirements and other regulations, as appropriate.   This role will also collaborate cross-functionally and work with our vendors to set eTMF practice and standards, including developing SOPs, work instructions, and operating templates.

The Trial Master File Specialist (TMF), monitors and manages overall performance of TMF build and certification process to drive quality and compliance across the organization. Reporting to the Exec. Director of Clinical Operations, he/she will be responsible for TMF quality, compliance, and inspection readiness at the R&D-wide level and contributes to decision-making authority for the overall TMF build and certification processes.

Job  Responsibilities:
  • Establish the strategy for development and management of an electronic TMF system.  This will involve project management and hands-on participation in the configuration and maintenance of the eTMF.
  • Serve as a business owner of the eTMF.
  • Facilitate the creation of the enterprise and study specific TMF management tools in compliance with regulations
  • Maintain TMF Management Plans and TMF Content Lists; work with the Study Teams to check and verify the plans and communicate the importance of each document to the Study Team based on risk level
  • Provide guidance on best practices for record handling, retrieval and archival procedures
  • Prepare and maintain manuals, training materials, policies and procedures and other quality documents as they apply to the management of records
  • Coordinate creation of the TMF filing locations within company based on the study specific TMF Content List
  • Participate in the Quality Control of documents (paper and electronic) submitted to the TMF or eTMF
  • Support the coordination of the transfer of study-specific trial master files from the CRO
  • Participate in Study Team meetings and provide/present regular TMF metrics updates
  • Maintain awareness of study events and the associated documentation requirements through collaboration with Study Team
  • Support Study Teams and designated Study Team Content owners in understanding their TMF-related responsibilities, requirements and expectations; act as an ad-hoc member of the Study Team
  • Act as point person for Study Team TMF questions and manage close-out of TMF related issues in adherence to processes
  • Support the Study Team in TMF document retrieval during Audits and Inspections (paper and electronic)
  • Manage the TMF content list and TMF Comprehensive Review tracker
  • Provide TMF metrics: completeness and quality of TMF documentation and content, including the percent completeness and the risk level of outstanding items on a periodic basis or as requested
  • Identify any corrective actions which must be addressed and assigned
  • Support the management of TMF documentation issues throughout the lifecycle of an assigned study
  • Provide archived records to users (e.g. internal staff and/or Auditors) for review. Oversee the provision of the required documents at the time of Regulatory Authority Inspection or internal Audits
  • Respond to TMF and non-TMF internal and/or external information inquiries related to Clinical Trial records
  • Identify opportunities for continuous process improvement. 


Qualifications/ Requirements:
  • Must enjoy working in working in a fast-paced, innovative environment. Must be flexible, proactive, and efficient.  Extensive knowledge of ICH-GCP guidelines and major Health Authority regulations as they pertain to the operational aspects of clinical studies and the management of TMF content. Excellent planning, organizational and time management skills.
  • BA/BS in life sciences
  • 8+ years of relevant pharmaceutical industry experience in developing and managing electronic TMFs within the pharmaceutical industry
  • Familiarity with the Trial Master File Reference model and a demonstrated understanding of records management best practices.
  • Extensive knowledge of clinical documents that are maintained in the eTMF.
  • Relevant certification, such as Registered Quality Assurance Professional, Certified Quality Auditor, CCRA or CCRC, Certified Clinical Research Professional, or Regulatory Affairs Certification a plus
  • Can demonstrate foundational technical skills in Regulations and Good Practices, as well as Quality Management.
  • Prior NDA inspection readiness experience is highly desired.
  • Full understanding of GCP principles, their importance, and how they apply to operational activities currently being performed
  • Strong team player that has a customer service approach and is solution oriented.
  • This is a highly visible, critical position which will require a self-starter with strong leadership, analytical and interpersonal skills.
]]>
Tue, 13 Feb 2018 00:00:00 EST 0
<![CDATA[Manager, Regulatory Operations]]> The successful candidate will be responsible for the maintenance and support of Regulatory systems used to facilitate the creation of compliant submissions and for the maintenance of Regulatory information. They will also support the compilation, archiving, and tracking of regulatory submissions and correspondence interfacing with Regulatory technology and publishing partners.

Job  Responsibilities:
  • Maintain and support Regulatory systems such as electronic document management (EDMS), Regulatory Information Management (RIM), and eCTD publishing
  • Manage and oversee the development of training materials specific to Regulatory systems
  • Liaise with internal and external stakeholders to ensure the compliance of deliverables being transmitted to a health authority
  • Represent Regulatory Operations on internal teams to support filing activities
  • Prepare and transmit electronic submissions (paper submissions, when applicable)
  • Interface with external publishing partners on submission compilation


Qualifications/ Requirements: 
  • 5-7 years’ experience working in a Regulatory Operations environment
  • Detailed knowledge of eCTD publishing systems, EDMS technology, and publishing software
  • Experience managing EDMS, regulatory publishing systems, and tracking databases
  • Detailed knowledge of clinical and nonclinical data standards (ADaM, SDTM, SEND)
  • Expert knowledge of Microsoft Office and Adobe Suite (MS Project is a plus)
  • Demonstrated experience and a clear understanding of submission content and format requirements
  • The ability to multitask, prioritize, and work under pressure in adhering to deadlines
  • Solid experience administering and maintaining Regulatory document authoring templates
  • Strong oral and written communication and interpersonal skills
  • Strong project management and organizational skills
]]>
Tue, 13 Feb 2018 00:00:00 EST 0
<![CDATA[Senior Medical Writer - Remote ]]> Our client is building the capacity of its internal medical writing team by combining the remote flexibility of freelance with the security of company benefits. The Medical Writing function is centralized providing a steady flow of documents to the group.  Our writers are able to focus energy on writing verses finding their next project. This sponsor also provides unmatched healthcare benefits coupled with an industry leading pension program.  Our client is consistently rated as a top employer and is projected for steady growth spanning three therapeutic areas.

Job Responsibilities:
  • Serve  as medical writing lead for clinical regulatory documents. Contribute  to the preparation and compilation of data and information for new and updated clinical regulatory documents (domestic and international.)
  • Effectively manage  timelines for clinical regulatory document deliverables.
  • Hold  team members accountable to agreed-upon project dates and with an appropriate quality level.
  • Negotiate  with functional areas on project outcomes and deliverables to meet conflicting demands.
  • Work  with Regulatory Quality Assurance throughout clinical regulatory document audit process
  • Knowledgeable of US and international regulations. Must be compliant with all current industry requirements as they relate to clinical regulatory submissions.


Qualifications/ Requirements:
  • Bachelor of Science required, with relevant writing experience, or Bachelor' s degree in English or communications, with relevant science experience.
  • AMWA certification is preferred
  • Three years’ industry experience in medical writing for regulatory, clinical research, or product support and R&D.
  • Knowledgeable of US and international regulations
  • Working knowledge of current electronic document management systems
  • Ability to assimilate and interpret scientific content and translate information for appropriate audience.
  • Excellent attention to detail. 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
]]>
Tue, 13 Feb 2018 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.
]]>
Mon, 12 Feb 2018 00:00:00 EST 0
<![CDATA[Associate Director, Medical Publications and Communications]]> Our client is seeking an Associate Director, Medical Publications and Communications. The successful candidate will be responsible for interacting with various investigators, HCPs, vendors, and internal departments to lead publications planning and management for assigned therapeutic area(s) while ensuring compliance with good publication practices and scientific merit of medical publications.

Job  Responsibilities:
  • Work with internal and external authors in actively facilitating the development of abstracts, posters, presentations, original manuscripts, and review papers.
  • Lead cross functional strategic publications efforts in alignment with product development teams to ensure prioritized submission and publication of data to address unmet educational needs.
  • Coordinate medical writing and external vendor activity to ensure timely delivery and submission of publications.
  • Ensure consistent adherence to established  publication process in accordance with good publication practices.
  • Manage assigned publications spend to ensure accurate accounting and reconciliation to available budget.
  • Collaborate with functions inside and outside of Medical Affairs to translate available data and publications into medical communications and educational resources.
  • Partner with Congress Strategy lead and conference planning team to map out oral and poster presentations.
  • Cover poster and scientific sessions at select medical conferences and write debriefs.


Qualifications/ Requirements:
  • This position requires a clinical and scientific background and significant biotechnology/pharmaceutical industry experience in leading publications efforts in a highly matrixed organization.
  • 8+ years in a biotechnology/pharmaceutical environment required. Has attention to detail, excellent communication and project management skills, and proven ability to effectively collaborate and influence decision-making across multiple levels of an organization, including senior leadership.
  • Willing and able to travel for medical conferences as necessary.
]]>
Fri, 09 Feb 2018 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.
]]>
Tue, 06 Feb 2018 00:00:00 EST 0
<![CDATA[Project Manager, Regulatory Science]]> My client is seeking a Project Manager, Regulatory Science. The purpose of this position is to provide project management for Regulatory Science for major marketing applications.  This position would serve as the lead project manager for these applications as well as additional submissions as assigned.   

Responsibilities:
  • Accountability for timeline development and management using MS Project and Project Server including execution of communication strategies to keep stakeholders aware and up to date on timelines and deliverables as well as cross-functional impacts of changes and decisions. 
  • Organizing and maintaining clear and timely team communications including: meeting agendas, minutes, decision logs, tasks lists, and risk analyses / mitigation strategies
  • Maintaining communications, timelines, and other project deliverables using preferred technologies such as Share Point, OneNote, and OneDrive
  • Identifying risks to project objectives, facilitation of mitigation and, if needed, escalating to Project Leadership in a timely manner
  • Organizing practice or “ mock” agency meeting sessions in preparation for Scientific Advice and pre-marketing application meetings. These responsibilities include working with Regulatory Science to prepare agendas, manage logistics, and organize location requirements

 

Requirements:
  • Accountability for Project Management of at least 1 major marketing application. Candidates who have participated on a major marketing application team in a leadership position will also be cosnidered.
  • A minimum of 7 – 10 years working for a company focused on the development of biotech and / or pharmaceutical products
  • A minimum of 5 years of project management experience.
  • Working knowledge of strategies and tools for ensuring clear and concise communication on cross-functional submission teams to ensure successful and timely project completion. 
  • Strong interpersonal and team skills
  • Strong verbal and written communication skills
  • Highly organized, proactive
  • Ability to analyze issues and develop solutions
  • Demonstrated ability to effectively manage multiple priorities and meet deadlines

 
]]>
Tue, 06 Feb 2018 00:00:00 EST 0
<![CDATA[Vice President, Pharmacovigilance]]> The Vice President of Pharmacovigilance will lead the strategic management, planning, and execution of Clinical Pharmacovigilance and risk management for early and late stage clinical development programs in compliance with the appropriate regulatory guidelines. Reporting to the Chief Medical Officer, this hire will interface with various functional areas and external resources, collaborating with clinical, regulatory, contract research organizations (CROs), and drug development collaborators/partners to ensure that all clinical safety pharmacovigilance is performed adequately across all ongoing clinical trials.

Job  Responsibilities:
  • Organizing and overseeing product safety surveillance and evolving safety profiles for clinical development of our products
  • Reviewing and approving drug safety information from clinical sources in accordance with WHO-ICH guidelines and the appropriate regulatory agencies, including FDA
  • Developing and implementing SOPs and other controlled documents to support investigational and marketed product safety surveillance
  • Identifying and analyzing safety signals
  • Performing aggregate analyses of specific events across studies, as indicated
  • Monitoring CRO performance to ensure optimal safety assessment and reporting of ongoing clinical trials
  • Overseeing new drug application safety updates, investigational new drug safety reports, investigator communications, Development Safety Update Reports (DSURs) and other reports as necessary
  • Participating on cross-functional product/project teams including review of safety sections of protocols, investigator brochures, informed consent forms, marketing documents, and other documents providing safety content
  • Developing and implementing Pharmacovigilance training programs for both internal and external use
  • Liaising with Medical Research, Clinical Operations, Regulatory Affairs and Quality to ensure appropriate and timely communication/dissemination of safety information to internal members and external stakeholders
  • Implementing, executing, and maintaining safety processes and systems
  • Monitoring industry best practices and global safety regulations to ensure continuous compliance
  • Preparing for regulatory inspections and audits and developing corrective action plans when needed


Qualifications/  Requirements:
  • MD degree in a health science, with relevant clinical experience
  • Previous management or project management experience
  • Preferred minimum of 8-10 years total experience in US and/or international pharmacovigilance/drug safety, or equivalent relevant clinical development experience in Pharmaceutical and/or Biotechnology industry
  • Expert knowledge of domestic and international regulatory safety reporting requirements, including FDA/ICH guidance’ s related to pharmacovigilance (e.g.E2B) and Good Clinical Practices, as well as working knowledge of Code of Federal Regulations regarding drug safety
  • Ability to achieve compliant solutions to complex problems in which analysis of situations or data requires an in-depth, strategic evaluation of various factors
  • Must have excellent, concise writing skills, excellent communication and interpersonal skills, and experience in working in multidisciplinary teams
  • Demonstrated leadership skills and ability to influence across external functions and within internal team
]]>
Mon, 05 Feb 2018 00:00:00 EST 0
<![CDATA[Vice President Pharmacovigilance]]> The Vice President of Pharmacovigilance will lead the strategic management, planning, and execution of Clinical Pharmacovigilance and risk management for early and late stage clinical development programs in compliance with the appropriate regulatory guidelines. Reporting to the Chief Medical Officer, this hire will interface with various functional areas and external resources, collaborating with clinical, regulatory, contract research organizations (CROs), and drug development collaborators/partners to ensure that all clinical safety pharmacovigilance is performed adequately across all ongoing clinical trials. 

Job Responsibilities:
  • Organizing and overseeing product safety surveillance and evolving safety profiles for clinical development of our products
  • Reviewing and approving drug safety information from clinical sources in accordance with WHO-ICH guidelines and the appropriate regulatory agencies, including FDA
  • Developing and implementing SOPs and other controlled documents to support investigational and marketed product safety surveillance
  • Identifying and analyzing safety signals
  • Performing aggregate analyses of specific events across studies, as indicated
  • Monitoring CRO performance to ensure optimal safety assessment and reporting of ongoing clinical trials
  • Overseeing new drug application safety updates, investigational new drug safety reports, investigator communications, Development Safety Update Reports (DSURs) and other reports as necessary
  • Participating on cross-functional product/project teams including review of safety sections of protocols, investigator brochures, informed consent forms, marketing documents, and other documents providing safety content
  • Developing and implementing Pharmacovigilance training programs for both internal and external use
  • Liaising with Medical Research, Clinical Operations, Regulatory Affairs and Quality to ensure appropriate and timely communication/dissemination of safety information to internal members and external stakeholders
  • Implementing, executing, and maintaining safety processes and systems
  • Monitoring industry best practices and global safety regulations to ensure continuous compliance
  • Preparing for regulatory inspections and audits and developing corrective action plans when needed


Qualifications/ Requirements:
  • MD degree in a health science, with relevant clinical experience
  • Previous management or project management experience
  • Preferred minimum of 8-10 years total experience in US and/or international pharmacovigilance/drug safety, or equivalent relevant clinical development experience in Pharmaceutical and/or Biotechnology industry
  • Expert knowledge of domestic and international regulatory safety reporting requirements, including FDA/ICH guidance’ s related to pharmacovigilance (e.g.E2B) and Good Clinical Practices, as well as working knowledge of Code of Federal Regulations regarding drug safety
  • Ability to achieve compliant solutions to complex problems in which analysis of situations or data requires an in-depth, strategic evaluation of various factors
  • Must have excellent, concise writing skills, excellent communication and interpersonal skills, and experience in working in multidisciplinary teams
  • Demonstrated leadership skills and ability to influence across external functions and within internal team

 
]]>
Mon, 05 Feb 2018 00:00:00 EST 0
<![CDATA[Contracts Manager]]> This position will provide legal support in connection with business contracts and arrangements involving various internal business partners across the company, including research and development, information technology, commercial, medical affairs, compliance, clinical operations, finance and/or human resources. 

This position will work directly with representatives from these groups and other members of the contracts team, as well as coordinate closely with members of the compliance, intellectual property and corporate teams within the legal department. 

Job Responsibilities:
  • Prepare, review and negotiate various agreements for internal business partners across the company (e.g., service agreements, consulting agreements, clinical trial agreements, material transfer agreements, sponsored research agreements, license agreements);
  • Identify and help resolve business issues in negotiations and collaborate with internal business partners to minimize company risk while supporting business objectives;
  • Identify and address legal and compliance issues in negotiating and drafting agreements;
  • Provide support on post-execution contract matters (e.g., amendments, terminations, payment and performance issues);
  • Develop, support and implement initiatives to improve the company’ s contracting processes and related procurement processes to improve efficiency and responsiveness;
  • Work closely with other members of the contracts team in a highly collaborative manner providing support and leadership;
  • Create, maintain and update contract templates as needed;
  • Identify and implement contracting best-practices;
  • Train internal business partners on contract-related matters, including contracting processes, contractual terms and use of contracts management tools and systems; and
  • Identify and address legal and contracting related needs of internal business partners as they develop.


Qualifications/ Requirements:
  • Minimum of 5-8 years contracts experience;
  • Strong experience in drafting and negotiating a high volume of consulting, services, advisory board, confidentiality, clinical trial, sponsored research, material transfer and license agreements;
  • Ability to handle complex, contested negotiations with limited supervision;
  • Strong drafting and analytical skills;
  • Ability to think creatively about problems and devise innovative solutions;
  • Understanding of complex legal and business concepts;
  • BA/BS degree.

Preferences:
  • Preference in contracts experience in the life sciences industry, with at least 2-4 years in research and development, information technology, and commercial functions;
  • Knowledge of fraud and abuse, anti-kickback, aggregate spend and anti-bribery laws and regulations strongly preferred; and
  • Experience implementing and refining contracting-related process and policy improvements preferred.
]]>
Mon, 05 Feb 2018 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;
]]>
Fri, 02 Feb 2018 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

 
]]>
Fri, 02 Feb 2018 00:00:00 EST 0
<![CDATA[Manager, Medical Information]]> Our client is seeking a Manager, Medical Information who will report to the Associate Director, Medical Information.

Job  Responsibilities:
  • Supports day to day operations of Medical Information Services function
  • Responsible for the Creation and maintenance of MI documents and ensures that information is scientifically accurate, timely, balanced, and meet customers’ needs
  • Manages medical information responses and materials through the internal medical, legal and regulatory review process  
  • Responsible for tracking responses to medical information requests from internal and external customers through the MI Response Center vendor 
  • Responsible for ensuring that the documentation of the MI inquiries and responses accurately and completely comply with relevant Standard Operating Procedure (SOP)/ Work Instruction and regulatory guidelines
  • Monitors adverse events and product quality complaints and processes in accordance with company SOPs
  • Assists in the creation of metric reports on key business processes to monitor Medical Information services
  • Liaise with publications and clinical development groups to develop and maintain timely and relevant product expertise
  • Perform critical analysis and synthesis of internal/external literature related to products and therapeutic areas of focus
  • Exhibits broad knowledge of assigned therapeutic areas, product labelling and regulatory guidance
  • Serves as Medical Affairs liaison to cross-functional groups for the incorporation of current medical/scientific information into departmental documents and processes. 


Qualifications/ Requirements:
  • Advanced clinical and scientific training/experience required equivalent to PharmD, PhD, MD or other advanced degree
  • Minimum of 2 years Medical Information experience with 5+ years in the pharmaceutical/ biotechnology industry
  • Understanding of and adherence to regulatory policies governing scientific interactions with physicians
  • Experience working with vendors on a day-to-day basis
  • Experience with data management and informatics;
  • Excellent written and oral communication skills;
  • Prior industry experience in a post-marketing setting
  • U.S. Launch experience; Orphan, CNS, and / or acute care preferred
  • Ability to quickly understand and communicate all clinical data / publications to support business objectives
  • An outstanding track record of strong communication, presentation, analytic and strategic capabilities
  • This position requires US and international travel, approximately 10 – 25%
]]>
Tue, 30 Jan 2018 00:00:00 EST 0
<![CDATA[Executive Assistant/Office Manager]]> Our client is hiring an  Office Manager/Executive Assistant to oversee  the general administration and office services for  office and support  CEO with some administrative tasks. The role reports to  VP of Talent.  This key role helps make the company a great place to work, provides our first   impression to many partners, prospective and new employees, and guests.

The ideal Office Manager will be experienced in managing a wide range of administrative and executive support-related tasks and will be able to work  independently with little or no supervision. This person must be exceedingly well
organized, flexible, and enjoy managing organizational effectiveness. The right
candidate will enjoy interfacing with executives, employees, and guests.

Job Responsibilities
  • Provide effective leadership to support a positive environment; develop operations and  procedures for administrative tasks, including catering, office supplies, travel, expense reporting
  • Plan and coordinate all administrative aspects of our Board of Director meetings
  • Assist CEO with administrative tasks including scheduling and event management
  • Supervise and coordinate the effective and timely preparation of various budgets and other  databases
  • Negotiate the purchase of all office supplies, furniture and office equipment for the company in  accordance with company purchasing policies and budgetary requirements
  • Manage files in SharePoint pertaining to contracts, legal records, leases and confidential files
  • Partner and support HR to maintain office policies as necessary
  • Assist with on-boarding functions of all new hires
  • Manage our weekly team lunch programs and agendas
  • Provide general support to visitors.


Qualifications/ Requirements:
  • College degree preferred
  • 3-5 years of experience
  • A self-starter; one who makes sound decisions, anticipates problems and pays close attention  to detail to maintain a well-functioning office environment
  • Solid knowledge of office management systems and procedures
  • Effective time management and organizational skills with a high level of attention to detail
  • Confident, confidential, self-motivated with a professional demeanor at all times
  • Proven office and project management experience in a fast-paced environment
  • Ability to work well under pressure and exercise sound judgment and discretion - feels no task is  too small
  • Excellent time management skills and ability to multi-task and prioritize work
  • Attention to detail
  • Solid problem-solving skills
  • Excellent written, verbal and interpersonal communications
  • Strong organizational and planning
  • Proficiency in G-suite. 
  • Ability to work overtime when needed
]]>
Thu, 25 Jan 2018 00:00:00 EST 0
<![CDATA[HR Manager]]> Support the strategic direction of the company by developing a positive and high performance team culture. This role encompasses the entire range of HR administration and employee relations, implementing and administering policies and programs in recruitment, organizational planning, training and development, employee relations and communications. 

Job Responsibilities
  • Ensure staffing of qualified employees by developing and managing recruitment, interview, selection and on-boarding process, including intern programs.
  • Serve as a link between management and employees by handling questions and helping to resolve work-related issues.
  • Organize and lead HR team at assigned locations by communicating expectations; planning, monitoring work, assessing results; enforcing policies and ensuring quality and productivity standards are achieved.
  • Take lead role in designing and facilitating on boarding programs, including management training and leadership development.  
  • Evaluate and recommend training resources to support employee development. 
  • Administer performance management program.


Qualifications/Requirements
  • Ability to work effectively with all levels of employees and management.
  • Ability to handle multiple projects simultaneously while maintaining quality standards.
  • Excellent organizational, leadership, interpersonal and communications skills.
  • Positive and professional demeanor, cooperative personality with ability to participate effectively in a collaborative team environment.
  • Optimize work of assigned department(s) and balance the work load appropriately; develop and implement efficiencies to improve the work flow; develop and oversee the training, development and evaluation of assigned staff and ensure smooth teamwork with other functions; and, ensure high quality standards are established and maintain
     
]]>
Thu, 11 Jan 2018 00:00:00 EST 0
<![CDATA[Manager/Sr. 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

 

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.

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.

 
]]>
Wed, 10 Jan 2018 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.
]]>
Mon, 08 Jan 2018 00:00:00 EST 0
<![CDATA[Manager of Medicaid Review]]> The Medicaid Revenue Manager is  responsible for oversight of the revenue process for communities participating in the program. The position requires a strong focus on training, development of policies and procedures, billing, internal audits, and compliance with company, state, and federal requirements.

Job Responsibilities:
  • Oversee entire Medicaid revenue process from referral/admission and billing to payment.
  • Provide leadership through effective goal setting, delegation and communication
  • Build professional relationships with local and state offices
  • Monitor daily Medicaid admits and discharges for entry into state system
  • Monitor completion of tasks and establish job responsibilities for staff
  • Train staff in Medicaid billing to complete duties within the scope of their position
  • Provide and implement policies and procedures for facility staff based on state requirements
  • Review and monitor aging report for Medicaid payer types
  • Direct staff to efficiently bill and collect accounts
  • Complete rebilling and collection projects
  • Oversee payment collection status from state agencies
  • Prepare analysis and projection reports to monitor collections and cash flow
  • Provide adequate billing programs and training to ensure high success rate of billing submissions allowing for expedited cash flow
  • Conduct collection meetings with Corporate and Business Office Staff
  • Monitor progress
  • Includes traveling to facilities


Qualifications
  • Bachelors degree preferred or High School diploma with 5-7 years of experience within healthcare industry, senior housing, or other related field
  • 1-2 years management experience (direct or indirect)
  • Strong knowledge of state and federal Medicaid requirements, submission process, contracts, and billing

 
]]>
Wed, 20 Dec 2017 00:00:00 EST 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[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