Senior Regulatory Medical Writer

Job Summary

The Senior Regulatory Medical Writer is responsible for providing high-quality medical and scientific writing support for Phase 1–3 clinical development programs involving pharmaceutical and biologic products. This position works closely with clinical, regulatory, medical, and cross-functional teams to plan, develop, review, and deliver high-quality regulatory documents within established timelines and quality standards.

The ideal candidate will have strong pharmaceutical/CRO experience, excellent scientific and medical writing skills, a solid understanding of clinical development and regulatory requirements, and the ability to manage multiple projects and deadlines in a fast-paced environment.

Key Responsibilities

• Serve as a primary author for regulatory and clinical documents supporting Phase 1–3 clinical development programs.
• Develop, write, and coordinate Clinical Study Protocols, Protocol Amendments, and Clinical Study Reports (CSRs) .
• Research, author, edit, and review complex clinical, scientific, and regulatory documents.
• Support preparation of Investigator’s Brochures (IBs), IND application documents, MAA documents , and other regulatory submission materials.
• Interpret clinical and scientific data and translate complex information into clear, accurate, and regulatory-compliant documents.
• Collaborate with clinical, biostatistics, data management, regulatory affairs, safety, medical affairs, and other functional teams to gather and validate document content.
• Review documents prepared by other medical writers and provide constructive feedback to ensure accuracy, consistency, and quality.
• Provide guidance, training, and mentorship to junior medical writers when needed.
• Ensure documents follow applicable regulatory guidelines, company SOPs, quality standards, client requirements, and document templates.
• Conduct detailed proofreading, editing, formatting, and quality-control reviews of assigned documents.
• Maintain consistency of terminology, formatting, references, data presentation, and scientific content throughout documents.
• Contribute to the development and improvement of medical writing processes, templates, best practices, and standard operating procedures.
• Support project management activities, including developing and monitoring timelines, tracking deliverables, managing priorities, and communicating project status.
• Assist with budget and forecast tracking and identify potential scope, timeline, or resource issues.
• Work directly with internal and external clients to understand requirements and ensure successful document delivery.
• Manage multiple projects simultaneously while meeting critical regulatory submission deadlines.
• Use appropriate AI and technology-enabled tools to improve document development efficiency and quality while following company policies and client requirements.
• Identify potential issues early and work with project teams to develop practical solutions.
• Maintain accountability for delivering high-quality work within established timelines and budgeted hours.

Required Qualifications

• Bachelor’s degree in a scientific or related discipline such as Biology, Chemistry, Pharmacy, Life Sciences, Clinical Research, or a related field .
• Advanced degree such as a Master’s, PharmD, or PhD is preferred.
• Typically 5+ years of relevant medical writing, regulatory writing, clinical research, pharmaceutical, or CRO experience .
• Experience working within pharmaceutical, biotechnology, or contract research organization (CRO) environments is preferred.
• Demonstrated experience authoring or substantially contributing to clinical and regulatory documents.
• Experience with Phase 1–3 clinical development programs is highly desirable.

Required Skills

• Excellent medical, scientific, and regulatory writing skills.
• Strong understanding of clinical development and regulatory documentation.
• Ability to interpret and communicate complex clinical and scientific data.
• Strong knowledge of global, regional, and national regulatory requirements and document-development guidelines.
• Excellent grammar, editing, proofreading, and quality-control skills.
• Strong project management and organizational skills.
• Ability to manage multiple priorities and meet tight deadlines.
• Excellent written and verbal communication skills.
• Strong interpersonal, collaboration, and problem-solving abilities.
• Ability to work effectively with internal teams, clients, and external stakeholders.
• Strong attention to detail and accuracy.
• Good judgment and decision-making skills.
• Ability to work independently while also contributing effectively to cross-functional teams.
• Strong computer skills, including Microsoft Word, Excel, and Outlook .
• Experience working with document management systems and client-specific templates.

Preferred Qualifications

• Experience with IND, MAA, NDA, BLA , or other regulatory submissions.
• Experience preparing CSRs, protocols, protocol amendments, and Investigator’s Brochures .
• Therapeutic-area expertise in areas such as oncology, immunology, infectious disease, CNS, cardiovascular, or other pharmaceutical specialties.
• Medical writing certification or professional affiliation such as AMWA, EMWA, or RAC .
• Experience mentoring or reviewing work produced by junior medical writers.
• Experience working directly with pharmaceutical or biotechnology clients.