Senior Nonclinical Writer - Regulatory Submissions

Alnylam Pharmaceuticals; United States; Hybrid; USD 124,000 - 167,000; Full time

Job summary

Alnylam Pharmaceuticals in Cambridge, MA is seeking a Manager, Nonclinical Writing to lead nonclinical submission content for regulatory filings. This hybrid role requires close collaboration with scientists in eDEV and Research, and coordination with Clinical, Medical Writing, Pharmacovigilance, Regulatory Affairs and Operations to ensure high-quality documents.

You will develop timelines, manage review cycles, and oversee outsourced writing staff while contributing to SOPs and templates to

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.
• Proven track record of managing multiple projects in a fast-paced and deadline-driven environment.
• Impeccable attention to detail and excellent written and oral communication skills.
• Proficiency in Microsoft Office; experience with electronic document management systems a plus.

Responsibilities

• Lead nonclinical writing assignments in conjunction with scientists and project team members for early development/late-stage programs in the preparation of nonclinical content for regulatory submissions.
• Leads document writing and review processes within department for individual projects.
• Develops and maintains timelines for document generation, revision, and completion, in collaboration with other project team members and Regulatory Affairs/Operations.
• Coordinate and manage review cycles for nonclinical documents in collaboration with subject matter experts, and lead discussions when needed.
• Edit/write nonclinical study report drafts from templates and interpret data as needed.
• Review and/or edit internal and external publications (e.g., manuscripts, abstracts, poster presentations, white papers).
• Independently manage outsourced writing staff and projects.
• Contribute to the development and maintenance of SOPs, templates, and style manuals.
• Provides communication and training on writing requirements and processes, templates, style guides, and SOPs within the department and cross-functionally.
• Provides quality control (QC) review of various regulatory and nonclinical documents as needed.
• Independently solve problems, exercising sound judgment, appropriate interfacing, and flexibility within a dynamic environment.

Skills

Attention to detail

Written communication

Project management

Regulatory submissions

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences

Tools

Microsoft Office

Visio

EDMS

Job description

Alnylam Pharmaceuticals in Cambridge, MA is seeking a Manager, Nonclinical Writing to lead nonclinical submission content for regulatory filings. This hybrid role requires close collaboration with scientists in eDEV and Research, and coordination with Clinical, Medical Writing, Pharmacovigilance, Regulatory Affairs and Operations to ensure high-quality documents.

You will develop timelines, manage review cycles, and oversee outsourced writing staff while contributing to SOPs and templates to