Sr. / Principal Medical Writer (Regulatory focus) - Sponsor-dedicated

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.

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 2.7.4, Clinical Study Reports (CSRs), Investigator Brochures (IBs), patient narratives, and integrated summaries of efficacy and safety. Experience with safety aggregate reports is strongly valued, along with experience preparing briefing books, ISEs, and ISSs. Strong understanding of regulatory medical writing principles, clinical development processes, and applicable regulatory guidelines. Excellent scientific writing, editing, proofreading, and document-quality skills, with a strong focus on accuracy and consistency. Strong project management capabilities, including the ability to coordinate multiple deliverables, stakeholders, priorities, and deadlines. Excellent client-facing and communication skills, with the ability to establish productive relationships and effectively manage feedback. Strong time-management and organizational skills, with the ability to work independently in a remote environment. Experience with clinical development processes and broader medical writing workflows is highly valued. Ability to collaborate effectively with multidisciplinary teams while also taking ownership of assigned deliverables. Candidates must be authorized to work in the United States; the position is part of a remote opportunity also open across the United States, United Kingdom, and Canada. Benefits: Salary: $80,600–$175,700 annual base salary range, with actual compensation determined by qualifications, skills, competencies, experience, and proficiency. Remote work: Remote position with flexibility based on approved locations. Healthcare: Medical, dental, and vision benefits. Retirement: 401(k) plan with company matching. Employee stock: Eligibility to participate in an Employee Stock Purchase Plan. Performance incentives: Eligibility to earn commissions or bonuses based on company and individual performance. Paid time off: Flexible PTO and sick time, subject to applicable federal, state, and municipal requirements. Additional compensation support: Certain roles or locations may include a company car or car allowance. Professional development: Opportunities for career development, progression, technical and therapeutic-area training, peer recognition, and internal growth. Collaborative environment: Work alongside multidisciplinary experts in a global, specialized life sciences environment with opportunities to contribute to meaningful clinical development programs. Career opportunities: Exposure to emerging technologies, data, scientific knowledge-sharing, and diverse career paths across clinical and functional disciplines.

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