Nonclinical Writing Manager

Overview

The Manager, Nonclinical Writing provides nonclinical submission support for scientific staff. This individual will represent Nonclinical Writing on project teams, working directly with scientists within the Early Development (eDEV) and Research departments and collaboratively with Clinical, Medical Writing, Pharmacovigilance, and Regulatory Affairs and Operations functions to lead the preparation of high-quality submission content for nonclinical summary document sections in support of global regulatory filings.

Hybrid role based in Cambridge, MA, with onsite presence aligned to team and business needs.

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 in support of regulatory submissions (eg, nonclinical protocols and reports, Investigator’s Brochures, Briefing Documents, INDs, IMPDs, annual reports/DSURs, NDA/MAAs).
• 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 (eg, 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, as required.
• 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.

Qualifications

• Bachelor's degree in Life Sciences with 4+ years’ experience in relevant field.  Professional certification/credentials, experience with regulatory submissions is a plus.
• In-depth knowledge of Good Laboratory Practices, FDA regulations, ICH guidelines, and the drug development process.
• Successful 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.