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Director, Medical Governance, Medical Affairs

Your role:

  • You will be responsible for ensuring EMD Serono North America Medical Affairs compliance with pharmaceutical regulations and laws as well as providing expertise on and medical topics in alignment with global R&D
  • Execute and continuously improve processes to ensure that North America Medical Affairs develops and delivers excellent interventional and observational studies (EMD Serono sponsored and Investigator Sponsored Studies) by applying methodology and compliance standards
  • Partner with global medical governance to review and contribute to conceptual design of study proposals. Provide direction and expert input to GCP; Insurance; Compliance; Regulatory and Legal related aspects of NA Medical Affairs studies
  • Act as deputy of the Senior Vice President of NA Medical Affairs and NA CMO in special cases like leading delegated meetings, taking over project roles and responsibilities for the NA CMO in relation to Governance & Compliance
  • Direct and manage the NA Medical Governance Office in accordance with the key accountabilities, including internal and external resources and being part of the North America Medical Affairs Leadership Team
  • Supervise, manage and direct the day-to-day business of the NA Medical Governance Office across all Therapeutic Areas in North America
  • Ensure appropriate medical representation as appropriate for Patient Support Programs in the US and Canada
  • Ensure NA Medical Affairs compliance and GCP related business activities are carried out following the appropriate guidelines and regulations governing NA Medical Affairs
  • Act as a member of the Development Excellence Council and ensure NA alignment to all global R&D policies and processes, implementing appropriate local addenda where necessary and aligning local EMD Serono policies to RDQ documentation
  • Represent NA Medical Affairs on the NA Compliance Committee
  • Lead and manage inspection and audit readiness across NA Medical Affairs, this includes risk management and implementation of mitigation plans and/or corrective action as needed
  • Deliver strategic input to CMO and NAMA Leadership Team and actively participate in strategic projects as needed
  • Develop, coordinate and provide trainings to NA and internal stakeholders on SOPs, related guidelines, best practices and NA processes for NAMA

 

Who you are:  

  • Advanced scientific degree (e.g. MD., PhD,) strongly preferred
  • Fluent in spoken and written English
  • Professional Skills, Qualifications and Experience
    • Minimum of 8 years professional experience in a Pharma / Biotech setting in various aspects of drug development process, specifically clinical, biostatistics, regulatory, safety, medical
    • 5+ years of US experience and demonstrated success in managerial position(s) involving influence and interaction with other departments and interaction with externals
    • Complex project management experiences
    • Thorough knowledge of ICH-GCP and applicable/valid US regulations, laws and guidelines
    • 20% travel required.
  • Physical Requirements (PPE, lifting)
  • Normal and routine office duties
Job Requisition ID:  186531
Location:  Rockland
Career Level:  E - Professional (10+ years)
Working time model:  full-time


Nearest Major Market: Boston

Job Segment: Medical, Biotech, Manager, Pharmaceutical, Biology, Healthcare, Science, Management

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