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Job

Senior Director Medical Writing, Oncology

  • Location

    REMOTE

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Fahd Joudi

  • Contact email:

    f.joudi@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    30 days ago

  • Expiry date:

    2023-06-26

  • Startdate:

    ASAP

Senior Director Medical Writing (Team Lead)

Key Responsibilities

  • Acts as an advisor to development functional groups on the content and optimal presentation of clinical/regulatory documents in accordance with regulatory document requirements/guidance.
  • For complex regulatory submissions, oversees strategic planning and manages cross-functional authoring teams to identify key document messages and substantiate data for delivery of target labels and to minimize regulatory questions.
  • Oversees and manages/supervises medical writers and contractors to ensure the highest quality of medical writing and adherence to our document standards.
  • Represents Medical Writing on cross-functional initiatives/teams backing key company goals.
  • Leads cross-functional process improvement initiatives on clinical document standards, template development, and document processes.
  • Assists with budgetary and resource projections for oncology programs and the department.
  • Author clinical/regulatory documents and perform other medical writing activities, working autonomously without direction, while ensuring effective teamwork with key contributors.
     

You Will Need

  • Extensive clinical research and development, regulatory affairs, or related industry or academic experience in a medical writing environment, managing staff and directing and preparing documents for regulatory submissions.
  • The ability to understand the needs of cross-functional teams and to lead strategy for resourcing and content of any medical writing deliverable.
  • The ability to balance integrity and efficiency when managing document and submission strategy.
  • Extensive knowledge of global regulatory affairs and particularly the requirements and mechanisms for regulatory approval in the United States and Europe.
  • Excellent medical writing, verbal communication, and project management skills.
  • Bachelor’s degree, or local equivalent.

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