About this opportunity
Alnylam lists this Principal Medical Writer opportunity in cambridge, Massachusetts. Review the employer’s description below for duties, qualifications and application requirements.
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
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Worksite address
cambridge, MA, 02140, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.