Medical Writing Science Senior Manager (Hybrid)
Vertex Pharmaceuticals
June 27, 2026
Remote friendly (Boston, MA)
United States
Clinical Research and Development
General Summary:
- Independently author complex clinical study documents and sections of regulatory submissions to support all phases of clinical drug development. May represent Medical Writing Science as a cross-functional team member for study-level and program-level activities.
Key Duties and Responsibilities:
- Author complex clinical regulatory documents (e.g., clinical study protocols, clinical study reports, investigator’s brochures, regulatory meeting documents, and marketing authorization application sections) with key stakeholders.
- Serve as lead Medical Writing Scientist for complex/pivotal studies across multiple programs/therapeutic areas.
- Provide expert review of study- and program-level documents.
- Develop key messages for complex clinical regulatory documents.
- Provide leadership for direction and regulatory strategy for clinical development programs.
- Contribute strategically and scientifically to regulatory documentation supporting the clinical development pipeline.
- Contribute to advisory committee presentations; may prepare briefing documents.
- Ensure document preparation complies with company and industry standards.
- Contribute to cross-functional efforts on SOPs, process improvements, and integration of new tools/technologies.
Knowledge and Skills:
- Outstanding written and oral communication.
- Extensive experience writing/editing clinical regulatory documents.
- Ability to analyze, interpret, and summarize highly complex data.
- Advanced understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology.
- Ability to mediate conflicts and facilitate idea exchange.
- Strong project management and organizational skills; ability to manage challenging, high-value projects.
Education and Experience:
- Bachelor’s degree in relevant discipline.
- Ph.D. (or equivalent).
- Typically requires 6 years of experience or equivalent education/experience.
- Independently author complex clinical study documents and sections of regulatory submissions to support all phases of clinical drug development. May represent Medical Writing Science as a cross-functional team member for study-level and program-level activities.
Key Duties and Responsibilities:
- Author complex clinical regulatory documents (e.g., clinical study protocols, clinical study reports, investigator’s brochures, regulatory meeting documents, and marketing authorization application sections) with key stakeholders.
- Serve as lead Medical Writing Scientist for complex/pivotal studies across multiple programs/therapeutic areas.
- Provide expert review of study- and program-level documents.
- Develop key messages for complex clinical regulatory documents.
- Provide leadership for direction and regulatory strategy for clinical development programs.
- Contribute strategically and scientifically to regulatory documentation supporting the clinical development pipeline.
- Contribute to advisory committee presentations; may prepare briefing documents.
- Ensure document preparation complies with company and industry standards.
- Contribute to cross-functional efforts on SOPs, process improvements, and integration of new tools/technologies.
Knowledge and Skills:
- Outstanding written and oral communication.
- Extensive experience writing/editing clinical regulatory documents.
- Ability to analyze, interpret, and summarize highly complex data.
- Advanced understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology.
- Ability to mediate conflicts and facilitate idea exchange.
- Strong project management and organizational skills; ability to manage challenging, high-value projects.
Education and Experience:
- Bachelor’s degree in relevant discipline.
- Ph.D. (or equivalent).
- Typically requires 6 years of experience or equivalent education/experience.