Yacht Life Sciences has a vacancy for an experienced Medical Writer. For the Medical Writing team of our client, we are looking for a (freelance/ ZZP) Medical Writer who will focus on writing clinical protocols and protocol amendments. This is a fully home-based position.

The responsibilities of the Protocol Writer may include, but are not limited to the following:

• Works independently to write and edit clinical protocols and protocol amendments.
• Negotiates timeline development for preparation of clinical protocols and if needed other clinical regulatory documents.
• Leads the process of critical review of clinical protocols and incorporates multiple reviews into successive drafts.
• Provides QC support for clinical protocols as needed.
• Reviews Statistical Analysis Plans, Statistical Programming Plans, data tables and listings, and other clinical regulatory documents as needed.
• Leads the preparation of briefing documents, INDs, licensing submissions (BLAs, MAAs), and other complex clinical regulatory documents as needed.
• Demonstrates critical thinking in the analysis and presentation of clinical study data.
• Reviews case report forms, statistical analysis plans, and data tables and listings for content and format.
• Assists with or leads the preparation or revision of SOPs, WPDs, and document templates. Assists with training across functional areas for the implementation of new/revised procedures and templates.
• Participates in clinical project team meetings.
• Participates in or leads other cross-functional team meetings and standards committees.
• Ensures the quality of clinical regulatory documents by maintaining and promoting familiarity with ICH, GCP, and other standards.
• Writing and editing clinical study reports, Investigator’s Brochures, Clinical Trial Results postings, annual reports, and other clinical regulatory documents across multiple therapeutic areas could be assigned as well.