Medical Writing Director
3 weeks ago
Job Type: Permanent, full-time
Location: Oxford, UK – Hybrid/Remote
Attractive salary and package
An exciting opportunity for an experienced Medical Writer to join a growing biotechnology company at the forefront of Oncology innovation within Radiopharmaceuticals.
Key Responsibilities:
- Oversee all medical writing activities and serve as an expert Medical Writer responsible for planning, developing, and writing clinical and regulatory documents.
- 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, including planning and authoring stages across all document types and regulatory submissions.
- 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.
Requirements:
- At minimum a degree in life sciences and at least 10 years of 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).
- Expert understanding and knowledge of regulatory requirements and drug development processes, regulatory requirements and guidelines associated with regulatory documents.
- Expert knowledge of document content preparation, including the use of style guides, medical dictionaries, and regulatory guidance documents and templates.
About Us:
Cpl Life Sciences is a leading provider of recruitment services to the life sciences industry.
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