Director Medical Writing

Position Summary: We are seeking an experienced Director, Medical Writing to lead the preparation of high-quality clinical and regulatory documents supporting global drug development programs. The successful candidate will have extensive experience authoring and leading documents for New Drug Application (NDA) submissions, with a strong understanding of FDA regulatory expectations. Experience supporting programs in Central Nervous System (CNS) therapeutics is highly preferred. This individual will work cross-functionally with Clinical Development, Regulatory Affairs, Biostatistics, Clinical Operations, Pharmacovigilance, and external vendors to ensure timely, accurate, and submission-ready documentation.

Key Responsibilities: Lead the planning, authoring, review, and finalization of clinical and regulatory documents across all stages of drug development. Serve as the medical writing lead for one or more development programs, ensuring document quality, consistency, and compliance with regulatory requirements. Author and oversee preparation of: Clinical Study Protocols and Protocol Amendments Clinical Study Reports (CSRs) Patients narratives Clinical Summaries and Overviews (Modules 2.5 and 2.7) Briefing Books Integrated Summaries of Safety (ISS) and Efficacy (ISE) Periodic safety update reports Responses to Health Authority questions NDA and other regulatory submission documents Lead medical writing activities supporting NDA submissions, ensuring documents meet FDA and ICH guidelines and submission timelines. Collaborate with multidisciplinary project teams to develop document strategies and manage writing timelines. Review source documents, statistical outputs, and clinical data to ensure scientific accuracy and consistency. Manage external medical writing vendors and consultants when appropriate. Develop and maintain medical writing processes, templates, style guides, and best practices. Mentor junior medical writers and contribute to departmental development and quality initiatives. Participate in regulatory strategy discussions and document planning meetings. QualificationsRequired 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 the biotechnology, pharmaceutical, or CRO industry. Demonstrated experience leading at least one successful NDA submission to the U.S. FDA. Extensive experience authoring CSRs, protocols, briefing documents, clinical summaries, and regulatory submission documents. Strong knowledge of: FDA regulatory requirements eCTD submission standards Excellent scientific writing, editing, and communication skills. Proven ability to manage multiple projects in a fast-paced environment. Experience leading cross-functional teams and managing external vendors. PreferredExperience supporting CNS (Central Nervous System) drug development programs, including neurology and/or psychiatry indications. Experience with global regulatory submissions (EMA, PMDA, NMPA, etc.). Experience with electronic document management systems (e.g., Veeva Vault, SharePoint). Previous people management or functional leadership experience. Experience in small-to-mid-sized biotech companies is preferred. We offer a competitive Benefits Package, including: Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage. Retirement Savings: 401(k) with employer match. Company Paid Life and Disability Insurance Communication Reimbursement Company shutdown for the yearend holidays Additional benefits include but are not limited to and may depend on eligibility: Wellness and Employee Assistance Programs, Flexible Spending Accounts, Health Savings Account, Commuter Spending Accounts, Paid Parental Leave (if eligible), Accident and Critical Illness Insurances, Legal Plans, Identity Theft Protection, Voluntary Life Insurance, Long Term Disability, Pet Insurance, and more. Fosun Pharma USA Inc. is an Equal Opportunity/Affirmative Action Employer and is committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Fosun’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law. Fosun Pharma USA Inc. maintains a drug-free workplace.