Medical Writer CNS, Biologics & Vaccines (No Oncology)

Accountabilities:: As a Medical Writer, you will be responsible for developing high-quality clinical and regulatory documentation while coordinating with multidisciplinary teams to support successful clinical development and regulatory submissions. 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. Requirements: The ideal candidate is a detail-oriented regulatory medical writing professional with recent CNS experience and a strong background in biologics or vaccines, capable of independently producing complex clinical documentation. 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. Important eligibility criteria: 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. Benefits: 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 the improvement of medical writing processes, templates and documentation standards.