Strategic Director of Clinical Content

3 days ago

London, Greater London, United Kingdom Clinical Professionals Limited Full time

Job Title: Associate Director of Medical Writing

Job Overview:



Clinical Professionals Limited is seeking an experienced Associate Director of Medical Writing to lead our medical writing activities and serve as an expert Medical Writer. The successful candidate will be responsible for planning, developing, and writing clinical and regulatory documents to support medical and regulatory activities across our portfolio.



About the Role:





  • Medical Writing Leadership: Oversee all medical writing activities and serve as an expert Medical Writer responsible for planning, developing, and writing clinical and regulatory documents.

  • Document Authorship: Lead the planning and authoring of complex, strategic clinical and regulatory documents and submission packages, including 7 CTD modules, investigators brochures, PIPs, DSURs, CSRs, Health Authority briefing books, clinical submission documents, and other clinical documentation.

  • Regulatory Compliance: Ensure that all documents are compliant with regulatory requirements and guidelines associated with regulatory documents.

  • Team Management: Manage the oversight of medical writing vendors/CROs, ensuring high performance standards are met.

  • Strategic Initiatives: Initiate and drive strategic medical writing initiatives and processes with high technical acumen to ensure execution on company priorities.



Requirements:





  • Education: A degree in life sciences, with a broad background that has given you a solid knowledge on clinical drug development and regulatory requirements.

  • Experience: At least 10 years' medical or regulatory/clinical writing experience, in the pharmaceutical industry.

  • Expertise: 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).

  • Skills: Expert understanding and knowledge of regulatory requirements and drug development processes, regulatory requirements and guidelines associated with regulatory documents, CTA/IND/HA regulatory submissions, plans required for the conduct of clinical studies, and clinical study data collection and results reporting.



About Us:



Clinical Professionals Limited is a growing biotechnology company that is at the forefront of Oncology innovation within Radiopharmaceuticals. We offer an attractive salary and package, and the opportunity to work on innovative projects that can make a real difference in people's lives.

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