Associate Director of Medical Writing

2 weeks ago

London, Greater London, United Kingdom Clinical Professionals Limited Full time
Associate Director, Medical Writing

Job Type: Permanent

Location: Oxford, UK – Hybrid/Remote

Remuneration: Attractive salary and package

An exciting opportunity has arisen for an experienced Medical Writer to join a growing biotechnology company at the forefront of Oncology innovation within Radiopharmaceuticals.

As an Associate Director, Medical Writing, you will oversee all medical writing activities and serve as an expert Medical Writer responsible for planning, developing, and writing clinical and regulatory documents to support medical and regulatory activities across the portfolio.

You will have an academic degree in life sciences with a broad background that has given you a solid knowledge on clinical drug development and regulatory requirements.

Key Responsibilities:

  • Apply expert medical writing proficiency to lead the planning and authoring of complex, strategic clinical and regulatory documents and submission packages.
  • Support medical writing activities across all stages of drug development.
  • Plan and author stages across all document types and regulatory submissions, including facilitating document contributor/review meetings, developing and managing timelines, coordinating document review, and driving decision-making.
  • Initiate and drive strategic medical writing initiatives and processes with high technical acumen to ensure execution on company priorities.
  • May be responsible for managing the oversight of medical writing vendors/CROs, ensuring high performance standards are met.
  • Actively provide input to the overall strategy, unified objectives, and areas for development of the Medical Writing department.

Requirements:

  • At minimum a degree in life sciences and at least 10 years' medical or regulatory/clinical writing experience, in the pharmaceutical industry.
  • Extensive experience writing protocols, investigator's brochures, clinical study reports, Health Authority briefing packages, Health Authority responses, and Paediatric Investigational Plans (PIPs).
  • Experience authoring clinical components in regulatory filings (NDA, BLA, MAA).
  • Expert understanding and knowledge of regulatory requirements and drug development processes, regulatory requirements and guidelines associated with regulatory documents (eg, protocols, investigator brochures, and clinical study reports), CTA/IND/HA regulatory submissions, plans required for the conduct of clinical studies, and clinical study data collection and results reporting.
  • Expert knowledge of document content preparation, including the use of style guides, medical dictionaries, and regulatory guidance documents and templates.

This is a perfect opportunity for a Principal Medical Writer to step into an Associate Director position and take the lead on all medical writing activities for innovative Radiopharmaceuticals.

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