Job Description

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Sr. / Principal Medical Writer (Regulatory focus) - Sponsor-dedicated based in the United States. This is a senior regulatory medical writing opportunity supporting clinical development programs in a sponsor-dedicated environment. You’ll lead the development of high-quality regulatory and clinical documents across Phase 2 and Phase 3 studies. The role spans key deliverables including protocols, CSRs, investigator brochures, submission documents, and integrated safety and efficacy summaries. You’ll work closely with cross-functional experts across biostatistics, regulatory affairs, medical affairs, and data management. As a senior subject-matter expert, you’ll help ensure scientific accuracy, regulatory compliance, consistency, and timely delivery. The position combines hands-on writing with project leadership, client collaboration, peer review, mentoring, and process improvement. This is a remote role open to candidates in the United States, with limited travel expected. Accountabilities: - Lead the preparation and delivery of clear, scientifically accurate, and regulatory-compliant medical writing deliverables across individual studies and broader clinical development programs. - Develop and oversee a wide range of documents, including clinical study protocols and amendments, clinical study reports, patient narratives, investigator brochures, informed consents, annual and safety reports, plain-language summaries, clinical development plans, briefing books, and regulatory submission materials. - Lead writing activities for CTD Modules 2. 7. 3 and 2. 7. 4, integrated summaries of efficacy and safety (ISE/ISS), NDA and eCTD submissions, and other regulatory deliverables.

- Coordinate medical writing activities across departments, manage document reviews, resolve client comments, and ensure deliverables remain aligned with project timelines and expectations. - Apply relevant regulatory standards and guidelines, including ICH E3, as well as approved templates, standard operating procedures, client standards, authorship requirements, and formatting guidelines. - Coordinate quality and editorial reviews, manage source documentation appropriately, and perform peer reviews to ensure scientific content, clarity, consistency, and formatting quality. - Review statistical analysis plans and table, figure, and listing specifications, providing input to clarify statistical outputs and document requirements. - Build strong working relationships with clients and cross-functional partners in biostatistics, data management, regulatory affairs, medical affairs, and other relevant functions. - Conduct clinical literature searches while ensuring appropriate compliance with copyright requirements. - Identify potential issues, recommend solutions, and escalate risks appropriately while supporting successful project delivery. - Provide technical guidance, consultation, and training to colleagues and contribute to internal materials, presentations, processes, and best practices. - Mentor and support less experienced medical writers on complex assignments and contribute subject-matter expertise on regulatory requirements and industry developments. - Monitor assigned project budgets and timelines, communicate status and changes to medical writing leadership, and complete required administrative activities within established deadlines. - Perform other related responsibilities as required, with limited travel of less than 25%. Requirements: - Minimum of 5 years of lead regulatory medical writing experience. - Demonstrated lead-writing experience supporting Phase 2 and Phase 3 clinical development programs . - Proven experience as lead writer for protocols, regulatory submissions, CTD Modules 2. 7. 3 and 2. 7.

Job Tags

Similar Jobs