Job description:
Yacht (Life Sciences) has a vacancy for a (Freelance) Senior Medical Writer to work at a multinational pharmaceutical company, who is willing to work fully remote.
Responsibilities:
The Senior Medical Writer will independently handle a variety of clinical and regulatory writing tasks, which may include:
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- Writing and editing clinical study reports (CSRs), Investigator’s Brochures, Clinical Trial Results postings, annual reports, and other clinical regulatory documents across multiple therapeutic areas. Coordination with contract writers may be required to meet deadlines.
- Reviewing clinical protocols, Statistical Analysis Plans (SAPs), Statistical Programming Plans, data tables, listings, and other regulatory documents as necessary.
- Leading the development of briefing documents, Investigational New Drug (IND) applications, licensing submissions (e.g., BLAs, MAAs), and other complex regulatory documents.
- Negotiating timelines for the preparation of clinical regulatory documents.
- Analyzing and presenting clinical study data with critical thinking.
- Managing the critical review process for regulatory documents and incorporating feedback into successive drafts.
- Providing quality control (QC) support for clinical documents, including cross-checking data and verifying content against source materials.
- Reviewing case report forms, statistical analysis plans, and data outputs for accuracy and compliance with required formats.
- Assisting with or leading the development and revision of standard operating procedures (SOPs), work process documents (WPDs), and document templates. Supporting cross-functional training initiatives for new/revised procedures and templates.
- Participating in clinical project team meetings.
- Engaging in or leading cross-functional meetings and standards committees.
- Ensuring the quality of regulatory documents by adhering to ICH guidelines, Good Clinical Practice (GCP), and other applicable standards.
This position offers an exciting opportunity to contribute to high-quality medical writing projects in a dynamic, multinational setting.
