Manager, Nonclinical Writing
Core
Lead nonclinical writing assignments and document review processes for early development and late-stage programs to support global regulatory filings.
Role type
Manager, Nonclinical Writing
Builds
Nonclinical summary documents, protocols, reports, Investigator's Brochures, Briefing Documents, INDs, IMPDs, annual reports/DSURs, and NDA/MAAs for regulatory submissions.
Domain
Life Sciences / Pharmaceutical Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Nonclinical writing, Regulatory submission management, Project management, SOP development, Quality control review, Outsourced staff management, Data interpretation, Template creation, Cross-functional collaboration
Preferred skills
Professional certification in regulatory writing, Experience with regulatory submissions
Technologies
Microsoft Suite
Responsibilities
Lead nonclinical writing assignments for regulatory submissions; Manage document writing and review processes; Develop and maintain timelines for document generation; Coordinate review cycles with subject matter experts; Edit and write nonclinical study report drafts; Review and edit internal and external publications; Independently manage outsourced writing staff and projects; Contribute to the development of SOPs, templates, and style manuals; Provide communication and training on writing requirements; Perform quality control reviews of regulatory and nonclinical documents.
Seniority
Manager, hands-on IC with team leadership
