Medical Writer

Yacht Life Sciences is seeking a highly skilled Principal Medical Writer to join our team. As a Principal Medical Writer, you will be responsible for writing and editing clinical study reports, Investigator's Brochures, Clinical Trial Results postings, annual reports, and other clinical regulatory documents across multiple therapeutic areas.

The ideal candidate will have 6+ years of experience writing high-quality clinical and regulatory documents, including clinical study reports, and will be proficient in Microsoft Office applications. They will also have familiarity with CTD, ICH, GCP, and other standards, as well as pharmaceutical or biotechnological industry experience.

The Principal Medical Writer will work independently to write and edit clinical regulatory documents, and will also lead the preparation of briefing documents, INDs, licensing submissions, and other complex clinical regulatory documents. They will demonstrate critical thinking in the analysis and presentation of clinical study data, and will lead the process of critical review of clinical regulatory documents.

The successful candidate will have a strong background in biologics, and will be fluent in English (both oral and written). They will also have experience with documentation like clinical protocols, INDs, BLAs, MAA's, SOP's, clinical study reports, Investigator's Brochures, Clinical Trial Results postings, and annual reports.

This is a full-time, remote position for 20-40 hours per week, with a contract for 1 year with the possibility of extension. The role can be performed as a freelancer within the EU, and the work schedule is flexible with a minimum of 20 hours per week.

Key Responsibilities:

• Write and edit clinical study reports, Investigator's Brochures, Clinical Trial Results postings, annual reports, and other clinical regulatory documents.
• Lead the preparation of briefing documents, INDs, licensing submissions, and other complex clinical regulatory documents.
• Demonstrate critical thinking in the analysis and presentation of clinical study data.
• Lead the process of critical review of clinical regulatory documents.
• Provide QC support for clinical regulatory documents as required.

Requirements:

• 6+ years of experience writing high-quality clinical and regulatory documents.
• Proficiency in Microsoft Office applications.
• Familiarity with CTD, ICH, GCP, and other standards.
• Pharmaceutical or biotechnological industry experience.
• Fluency in English (both oral and written).