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.

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 2.7.4, 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.