Nonclinical Writing Manager — Regulatory Submissions

Alnylam Pharmaceuticals; Cambridge (MA); Hybrid; USD 124,000 - 167,000; Full time

Job summary

Alnylam Pharmaceuticals in Cambridge, MA is seeking a Manager, Nonclinical Writing to provide submission support for scientific staff and lead the preparation of nonclinical content for regulatory filings.

You will represent Nonclinical Writing on project teams, collaborate across Early Development, Research, Clinical, Medical Writing, and Regulatory Affairs, and manage internal and outsourced writing resources to ensure high-quality documents.

Qualifications

• Bachelor's degree in Life Sciences with 4+ years' experience in relevant field.
• Knowledge of Good Laboratory Practices, FDA regulations, ICH guidelines, and drug development.
• Able to manage multiple projects in a fast-paced, deadline-driven environment.
• Impeccable attention to detail with strong written and oral communication skills.
• Proficiency in Microsoft Office; experience with electronic document management systems is a plus.

Responsibilities

• Lead nonclinical writing assignments with scientists for regulatory submissions.
• Lead document writing and review processes within the department.
• Develop and maintain timelines for document generation, revision, and completion.
• Coordinate and manage review cycles with SMEs and lead discussions as needed.
• Edit/write nonclinical study report drafts from templates and interpret data as needed.
• Review and/or edit internal and external publications (manuscripts, abstracts, posters, white papers).
• Independently manage outsourced writing staff and projects.
• Contribute to SOPs, templates, and style manuals.
• Provide training on writing requirements, templates, style guides, and SOPs.

Skills

Scientific writing

Project management

Written communication

Oral communication

Education

Bachelor's degree in Life Sciences

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Visio

Job description

Alnylam Pharmaceuticals in Cambridge, MA is seeking a Manager, Nonclinical Writing to provide submission support for scientific staff and lead the preparation of nonclinical content for regulatory filings.

You will represent Nonclinical Writing on project teams, collaborate across Early Development, Research, Clinical, Medical Writing, and Regulatory Affairs, and manage internal and outsourced writing resources to ensure high-quality documents.