Principal Medical Writer
Core
Lead the development of clinical documents and regulatory submissions for drug development programs, ensuring compliance with regulations and GCPs.
Role type
Senior IC medical writer (clinical/regulatory)
Builds
Clinical protocols, investigator brochures, clinical study reports, integrated efficacy and safety summaries, informed consent forms, health authority briefing books, and scientific publications.
Domain
Life Sciences / Clinical Research / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical document development, regulatory submission management (NDA/BLA/MAA), GCP compliance, FDA/ICH guidelines knowledge, project management, contract writer oversight, process standardization, training and mentoring, eCTD formatting, EDMS systems, Microsoft Office proficiency.
Preferred skills
Advanced degree, professional certification, CTA/IND experience, experience with rest-of-world filings, experience developing MW processes and standards.
Technologies
eCTD, EDMS, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Windows
Responsibilities
Produce high-quality and on-time clinical documents; Independently plan, coordinate, develop, update, and revise key 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; Facilitate/manage efficient review and finalization process for documents produced internally and/or externally; Collaborate effectively with Biometrics, Clinical Operations, Clinical Development, Pre-Clinical Development, Program Management, Research, Quality, and Corporate Communications; Contribute to the development and standardization of templates and related processes; Assist in the training and development of junior staff.
Seniority
Senior, hands-on IC with mentorship responsibilities
