Principal Medical Writer

Alnylam; Cambridge (MA); On-site; USD 100,000 - 140,000; Full time

Job summary

A leading biotech company based in Cambridge, Massachusetts, is looking for a Principal Medical Writer to represent medical writing on multi-disciplinary teams. This role involves producing high-quality clinical documents, independently coordinating the development and revision of key documents, and providing subject matter expertise. The ideal candidate will lead supplemental filings and collaborate with project teams to ensure timely completion. This position operates without direct report responsibilities, equivalent to the Associate Director level.

Responsibilities

• Produce high-quality and on-time clinical documents.
• Independently plan, coordinate, develop, update, and revise key documents.
• Independently lead supplemental filings and clinical responses.

Job description

The Principal Medical Writer represents medical writing on multi-disciplinary teams, collaborates on the development of clinical documents in accordance with all applicable regulations, Good Clinical Practices, and Standard Operating Procedures (SOPs), and oversees the work of internal and contract writers. This is an individual contributor position, equivalent to the Associate Director, without direct report responsibilities.

Responsibilities

• Produce high-quality and on-time clinical documents
• Independently plan, coordinate, develop, update, and revise key documents, including clinical protocols, investigator brochures, clinical study reports, integrated efficacy and safety summaries, and related documents.
• Independently lead supplemental filings, Type 2 Variations, rest-of-world filings, and clinical responses to questions
• Provide medical writing subject matter expertise and leadership to project teams and collaborate with the Medical Writing line management to ensure proper planning and resourcing for upcoming project team