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Principal Medical Writer

Sobi

Apply before: May 9, 2024
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  • Date posted
    March 10, 2024
  • Location
    Remote (US)
  • Apply before
    May 9, 2024
  • Career Level
    Senior

Job Description

We are looking for an experienced Medical Writer. The role is a permanent position reporting to the Head of Medical Writing. The Principal Medical Writer will provide expert leadership, strategic thinking and communication skills and expertise in the preparation of clinical regulatory documents throughout drug development, post-marketing and life-cycle management. Lead a strategy-driven approach to authoring of the clinical components of regulatory submissions, ensuring a clear, concise and complete scientific content aligned with the objective of the regulatory document. Assume primary responsibility for preparation of key clinical regulatory documents and documents supporting major regulatory submissions as well as responses to regulatory agencies/ health authorities. Provide leadership and project coordination to cross-functional authoring teams, ensuring efficient delivery, high quality, and regulatory compliance of clinical regulatory documents. Liaise with senior project staff, prospectively develop a storyboard for the submission, and plan document development to provide optimal support for the proposed prescribing information. Assume a Product Medical Writer responsibility, providing strategic medical writing expertise and support to multiple projects in a clinical development program. Ensure high technical quality of the documents in compliance with in-house technical requirements. Coach and develop less experienced Medical Writers. Oversee and coordinate all Medical Writers assisting on documents under your responsibility, including in-house consultants and Medical Writers at CRO.