Director, Medical Writing — NDA Submissions Lead

Fosun Pharma USA Inc.; New York (NY); On-site; USD 170,000 - 260,000; Full time

Benefits offered by this job

Health Insurance

401(k) with employer match

Life and Disability Insurance

Commuting/Travel Reimbursement

Paid Year-End Holidays

Job summary

Fosun Pharma USA Inc. is seeking an experienced Director of Medical Writing to lead the preparation of high-quality clinical and regulatory documents supporting global drug development programs.

The role requires extensive experience with NDA submissions and FDA expectations, with CNS programs highly preferred. You will collaborate across Clinical Development, Regulatory Affairs, Biostatistics, Operations, and external vendors to ensure timely, accurate, and submission-ready documentation,

Qualifications

• Advanced degree in Life Sciences, Pharmacy, Medicine, Nursing, or related scientific discipline (PhD, PharmD, MD, MS, or equivalent).
• Minimum 10 years of medical writing experience within biotech, pharma, or CRO.
• Experience leading at least one NDA submission to US FDA.
• Experience authoring CSRs, protocols, briefing documents, clinical summaries, and regulatory submissions.
• Strong knowledge of FDA regulatory requirements and eCTD submission standards.

Responsibilities

• Lead planning, authoring, review, and finalization of clinical and regulatory documents across drug development stages.
• Act as the medical writing lead for development programs, ensuring quality and regulatory compliance.
• Prepare CSRs, protocols, summaries, briefing books, and NDA submissions.
• Collaborate with cross-functional teams and manage external vendors.
• Mentor junior writers and contribute to process improvement.

Skills

Medical writing leadership

FDA regulatory knowledge

eCTD expertise

Cross-functional collaboration

Vendor management

Education

Advanced degree in Life Sciences, Pharmacy, Medicine, Nursing, or related discipline

Tools

Veeva Vault

SharePoint

Job description

Fosun Pharma USA Inc. is seeking an experienced Director of Medical Writing to lead the preparation of high-quality clinical and regulatory documents supporting global drug development programs.

The role requires extensive experience with NDA submissions and FDA expectations, with CNS programs highly preferred. You will collaborate across Clinical Development, Regulatory Affairs, Biostatistics, Operations, and external vendors to ensure timely, accurate, and submission-ready documentation,