Job Description

Job Title: Sr. Scientific & Regulatory Writer
Location: Remote (EST or PST hours)
Experience: 6 10 years

The Sr. Scientific & Regulatory Writer will be responsible for developing, writing, and editing high-quality clinical and regulatory documents that support the conduct, reporting, and submission of clinical trials. This role requires strong scientific understanding, attention to detail, and the ability to collaborate effectively with cross-functional teams in a fast-paced drug development environment.

• Draft, edit, and finalize documents related to clinical studies, including protocols, amendments, informed consent forms, and clinical study reports (CSRs).

• Prepare and maintain regulatory and safety documents such as Investigator's Brochures (IBs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Development Safety Update Reports (DSURs).

• Contribute to regulatory submissions by writing and reviewing documents such as briefing books and eCTD Module 2/5 components, including integrated summaries.

• Manage document development timelines, facilitate team meetings, coordinate reviews, and oversee comment resolution.

• Represent the Medical Writing function at study and cross-functional team meetings to ensure alignment with development goals and timelines.

• Collaborate closely with internal partners such as clinical, regulatory, biostatistics, and pharmacovigilance teams to ensure content accuracy and consistency.

• Provide peer review and editing support for clinical and regulatory materials such as statistical analysis plans, CRFs, and other study documents.

• Contribute to the development and improvement of writing standards, templates, and processes within the Medical Writing function.

• Ensure compliance with departmental procedures, industry regulations, and applicable style guides (e.g., AMA, CBE, Chicago Manual of Style).

Education:

• Bachelor's degree or higher in a scientific, medical, or related discipline.

• Professional certification or training in medical writing (e.g., AMWA certificate, DIA coursework) preferred.

Experience:

• 6 10 years of medical or scientific writing experience, including at least 6 years in the pharmaceutical or biotechnology industry.

• Proven experience drafting and editing protocols and clinical study reports.

• Strong understanding of drug development, clinical research, and regulatory documentation processes.

• Experience writing or contributing to INDs, BLAs/NDAs, PBRERs, DSURs, and regulatory briefing books preferred.

• Proficient with documentation requirements across all phases of clinical development.

• Skilled in interpreting and presenting clinical data in text, tables, and figures.

• Proficiency in Microsoft Word, Excel, PowerPoint, MS Project, and Adobe Acrobat.

• Familiarity with document management systems (e.g., SharePoint, Veeva, LiveLink).

• Working knowledge of eCTD structure and regulatory submissions.

• Understanding of MedDRA and WHO Drug dictionaries.

• Strong written and verbal communication skills with the ability to convey complex information clearly and concisely.

• Excellent organization and time management; able to manage multiple deliverables and shifting priorities.

• Demonstrated leadership in coordinating cross-functional document development.

• High attention to detail and commitment to accuracy and quality.

• Collaborative mindset with the ability to build relationships across teams.

• Initiative-driven, proactive, and adaptable to evolving project needs.

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