Serve as the primary medical writing lead for one or more clinical programs.
Provide day-to-day leadership for medical writing activities across assigned programs.
Shape and maintain writing standards, templates, and best practices to ensure consistency and quality.
Provide expert guidance to cross functional teams on document expectations, structure, and delivery timelines.
Lead and/or author high-quality clinical documents, including Protocols & amendments, Clinical Study Reports (CSRs), Investigator’s Brochures (IBs).
Support Regulatory consultations & submissions (e.g. INDs, FDA/EMA/PMDA briefing documents).
Partner closely with Clinical Development, Biostatistics, Data Management, Regulatory Affairs, and all stakeholders to ensure smooth and timely documentation delivery.

Requirements

Advanced degree in life sciences (PhD, PharmD, MD, or MSc).
7–8+ years of medical writing experience in pharma, biotech, or CRO settings.
Strong experience with clinical and regulatory document development across multiple phases of clinical research.
Experience with global regulatory submissions preparation (NDA/BLA/MAA).
Demonstrated leadership capability, including experience guiding teams or managing complex writing projects.
Exceptional communication, scientific interpretation, and organizational skills.
Experience in oncology, rare disease, or other complex therapeutic areas.
Strong knowledge of ICH guidelines, GCP, and global regulatory frameworks.
Familiarity with document management systems.

Benefits

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

medical writingclinical document developmentregulatory submissionsclinical study reportsprotocolsinvestigator's brochuresICH guidelinesGCPNDABLA

Soft Skills

leadershipcommunicationscientific interpretationorganizational skills

Certifications

PhDPharmDMDMSc