Medical Writing Consultant, Regulatory Submissions

Job Description

Medical Writing Consultant (Contract)

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Location: Remote

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About Fosun Pharma USA Inc.

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Company Introduction

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Fosun Pharma is a global innovation-driven pharmaceutical and healthcare group committed to improving human health through integrated capabilities in pharmaceuticals, medical devices, diagnostics, and healthcare services. With a strong presence in both established and innovative medicines, Fosun Pharma leverages global R&D, strategic partnerships, and commercialization excellence to deliver high-quality healthcare solutions worldwide.

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Fosun Pharma USA serves as a key strategic hub supporting commercialization, business development, and operational functions across North America, while closely collaborating with global headquarters and international affiliates.

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Position Summary

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We are seeking an experienced Medical Writing Consultant to support the preparation of high-quality clinical and regulatory documents for a global drug development program on a contract basis. The ideal consultant will bring hands-on experience authoring and leading documents for New Drug Application (NDA) submissions, with a strong understanding of FDA regulatory expectations. Experience supporting Central Nervous System (CNS) therapeutics is highly preferred.

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This is an engagement-based role requiring close collaboration with Clinical Development, Regulatory Affairs, Biostatistics, Clinical Operations, Pharmacovigilance, and external vendors to ensure timely, accurate, and submission-ready documentation.

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Key Responsibilities

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• Lead or support the planning, authoring, review, and finalization of clinical and regulatory documents across development stages
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• Serve as medical writing lead or contributor for one or more development programs, ensuring document quality, consistency, and regulatory compliance
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• Author and/or oversee preparation of: Clinical Study Protocols and Protocol Amendments, Clinical Study Reports (CSRs), Investigator's Brochures (IBs), Informed consent forms, Patient 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
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• Support medical writing activities for NDA submissions, ensuring documents meet FDA and ICH guidelines and timelines
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• Collaborate with cross-functional project teams on document strategy and writing timelines
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• Review source documents, statistical outputs, and clinical data for scientific accuracy and consistency
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• Partner with or manage external medical writing vendors as needed
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• Contribute to medical writing processes, templates, and best practices for the duration of the engagement
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Qualifications

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Required

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• Advanced degree in Life Sciences, Pharmacy, Medicine, Nursing, or related scientific discipline (PhD, PharmD, MD, MS, or equivalent).
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• Minimum 10 years of medical writing experience within the biotechnology, pharmaceutical, or CRO industry.
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• Demonstrated experience leading at least one successful NDA submission to the U.S. FDA.
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• Extensive experience authoring CSRs, protocols, briefing documents, clinical summaries, and regulatory submission documents.
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• Strong knowledge of: ICH Guidelines (E3, E6, M4), FDA regulatory requirements & eCTD submission standards
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• Excellent scientific writing, editing, and communication skills.
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• Proven ability to manage multiple projects in a fast-paced environment.
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• Experience leading cross-functional teams and managing external vendors.
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• Preferred
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• Experience supporting CNS (Central Nervous System) drug development programs, including neurology and/or psychiatry indications.
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• Experience with global regulatory submissions (EMA, PMDA, NMPA, etc.).
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• Experience with electronic document management systems (e.g., Veeva Vault, SharePoint).
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• Previous people management or functional leadership experience.
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• Experience in small-to-mid-sized biotech companies is preferred.
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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.

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Fosun Pharma USA Inc. maintains a drug-free workplace.

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Agency Notice

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Please note that Fosun Pharma USA Inc. has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Fosun Pharma USA's Human Resources department to submit resumes for a specific position, Fosun will not approve, nor will be under an obligation to make any payment to such non approved third parties in the event a candidate they refer is hired by Fosun Pharma USA.

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