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Medical Writer
Sigma Systems. Author, edit, and review clinical and regulatory documents, including Clinical Study Protocols and Protocol Amendments, Clinical Study Reports, Investigator Brochures, Regulatory Briefing Books, IND and NDA submission documents, and other clinical and regulatory summary documents .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory medical writing, including authoring and editing clinical study protocols, Clinical Study Reports, and regulatory submission documents. Proficient in collaborating with cross-functional teams and ensuring compliance with regulatory guidelines and ICH requirements.
Highest-signal resume keywords
Regulatory Medical WritingClinical Study Protocol DevelopmentIND/NDA Submission PreparationCNS Therapeutic Area ExperienceICH Guidelines Compliance
ATS Keywords
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Hard Skills
Clinical Study ProtocolsClinical Study ReportsInvestigator BrochuresRegulatory Briefing BooksDocument Review CoordinationScientific WritingEditingRegulatory RequirementsGood Clinical PracticeBiologics Development
Soft Skills
Communication SkillsNegotiation SkillsTime ManagementCollaboration
Industry Keywords
Pharmaceutical IndustryBiotechnologyClinical ResearchHealth Authority InteractionsInspection ReadinessGlobal Clinical DevelopmentCross-Functional Teams
About the role
Key responsibilities & impact- Author, edit, and review clinical and regulatory documents, including Clinical Study Protocols and Protocol Amendments, Clinical Study Reports, Investigator Brochures, Regulatory Briefing Books, IND and NDA submission documents, and other clinical and regulatory summary documents
- Translate complex scientific, clinical, and statistical information into clear, accurate, and submission-ready documentation
- Collaborate with Clinical Development, Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, Pharmacovigilance, and Medical Affairs teams
- Coordinate document review cycles, incorporate reviewer feedback, and resolve comments
- Manage document development timelines and negotiate deliverables with cross-functional stakeholders
- Ensure documents comply with applicable regulatory guidelines, ICH requirements, Good Clinical Practice, and internal quality standards
- Support regulatory submissions, health authority interactions, and inspection readiness activities
- Contribute to improving medical writing templates, processes, style guides, and documentation standards
Requirements
What you’ll need- Bachelor's degree or higher in a relevant scientific, medical, pharmacy, or life sciences discipline
- Minimum of 5+ years of hands-on regulatory medical writing experience in the pharmaceutical, biotechnology, or clinical research industry
- Recent CNS (Central Nervous System) therapeutic area experience is required
- Demonstrated experience independently authoring clinical and regulatory documents
- Strong experience developing clinical study protocols, CSRs, Investigator Brochures, and regulatory submission documents
- Strong understanding of clinical development processes, regulatory requirements, and ICH guidelines
- Excellent scientific writing, editing, and communication skills
- Experience coordinating document review cycles and working with cross-functional clinical development teams
- Ability to manage multiple deliverables, negotiate timelines, and work independently
- Availability for U.S. East Coast business hours
- Availability for occasional early-morning meetings (approximately 8:00 AM ET) and evening meetings (approximately 6:00–8:00 PM ET) to coordinate with Japan-based teams
- Experience supporting biologics or vaccine development programs is highly desirable
- Experience preparing IND/NDA submissions and regulatory briefing packages
- Familiarity with global clinical development programs and international regulatory requirements
- Experience working with cross-functional teams across U.S. and Japan time zones
- Candidates must have direct, hands-on experience authoring clinical and regulatory documents
- Candidates whose experience is exclusively or predominantly oncology-focused, particularly those with several years of recent oncology-only medical writing experience, may not be suitable
Benefits
Comp & perks- Fully remote contract opportunity
- Flexible hours
- Flexible part-time to full-time workload, approximately 20–40 hours per week
- Potential for increased hours and responsibilities based on project needs and performance
- Opportunity to take on additional hours and responsibilities based on project requirements and performance
- Collaboration with international pharmaceutical and biotechnology teams