Medical Writer CNS, Biologics & Vaccines; No Oncology

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Medical Writer CNS, Biologics & Vaccines (No Oncology) based in the United States.

We are seeking an experienced Regulatory Medical Writer to support clinical development programs within a global biopharmaceutical environment, focusing on Central Nervous System (CNS) indications, biologics and vaccines. In this hands-on role, you will author and edit essential clinical and regulatory documents, ensuring compliance with international guidelines and quality standards. You will collaborate with cross-functional teams spanning Clinical Development, Regulatory Affairs, Biostatistics, Pharmacovigilance and Medical Affairs.

Your expertise will help translate complex scientific data into clear, accurate and submission-ready documentation. You will also coordinate review cycles, manage stakeholder feedback and ensure critical deliverables remain on schedule. This remote opportunity initially offers 20-40 hours per week, with potential to expand working hours and responsibilities over time.

• Author, review and edit clinical and regulatory documents for CNS development programs, ensuring scientific accuracy, clarity and consistency.
• Develop clinical study protocols and protocol amendments in accordance with applicable regulatory requirements.
• Prepare and maintain Investigator's Brochures (IBs) and Clinical Study Reports (CSRs).
• Create briefing books and supporting documentation for health authority meetings.
• Draft IND and NDA summary documents, submission materials and other regulatory deliverables.
• Ensure all documentation complies with International Council for Harmonisation (ICH) guidelines, Good Clinical Practice (GCP) requirements and internal quality standards.
• Collaborate with Clinical Development, Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, Pharmacovigilance and Medical Affairs teams.
• Coordinate document review cycles, consolidate and resolve reviewer comments, and facilitate alignment among cross-functional stakeholders.
• Negotiate document timelines, manage competing priorities and ensure deliverables are completed according to agreed schedules.
• Contribute to continuous improvement initiatives involving medical writing processes, document templates and style guides.

• At least 5 years of hands-on regulatory medical writing experience within the pharmaceutical, biotechnology or Contract Research Organization (CRO) industry.
• Recent experience writing clinical and regulatory documents for Central Nervous System (CNS) programs, particularly in neurology or psychiatry.
• Demonstrated medical writing experience in biologics or vaccines.
• Proven experience authoring clinical study protocols, Clinical Study Reports (CSRs), Investigator's Brochures (IBs) and regulatory submission documents.
• Strong knowledge of ICH guidelines, Good Clinical Practice (GCP) and clinical development processes.
• Excellent scientific writing, editing and document management skills, with the ability to communicate complex clinical information clearly and accurately.
• Experience coordinating cross-functional document reviews, incorporating stakeholder feedback and managing regulatory deliverables.
• Availability to work during U.S. Eastern Time business hours, including occasional meetings at 8:00 AM ET and between 6:00 PM and 8:00 PM ET to accommodate teams based in Japan.
• Bachelor's degree or higher in a relevant scientific or medical discipline; an advanced degree is preferred.

• Candidates must have recent CNS medical writing experience combined with biologics or vaccine experience.
• Applicants whose recent experience is exclusively in oncology will not be considered.
• Medical communications or pharmaceutical marketing writers without hands-on regulatory document authoring experience are not a suitable match.

• Fully remote working arrangement.
• Flexible initial workload of 20-40 hours per week.
• Opportunity to increase working hours and take on additional responsibilities over time.
• Opportunity to contribute to clinical development programs within a global biopharmaceutical environment.
• Exposure to a broad range of clinical and regulatory documentation, including protocols, CSRs, Investigator's Brochures and regulatory submissions.
• Collaboration with international, multidisciplinary teams across clinical, scientific and regulatory functions.
• Opportunity to contribute to…