Medical Writing Science Senior Manager (Hybrid)
Vertex Pharmaceuticals
August 09, 2026
Remote friendly (Boston, MA)
United States
Clinical Research and Development
General Summary:
- The Medical Writing Science Senior Manager independently authors 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 sections of marketing authorization applications) with key stakeholders.
- Serve as lead Medical Writing Scientist for complex/pivotal clinical studies across multiple programs/therapeutic areas.
- Provide expert review of study-level and program-level documents.
- Develop key messages for complex clinical regulatory documents.
- Provide leadership on teams defining direction and regulatory strategy for clinical development programs.
- Contribute strategic/scientific input to regulatory documentation for the clinical development pipeline.
- Contribute to advisory committee presentation content; may prepare briefing documents.
- Ensure document preparation complies with company and industry standards.
- Contribute to cross-functional teams on SOPs, process improvements, and integration of new tools/technologies.
Knowledge and Skills:
- Outstanding written and oral communication skills.
- 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 through negotiation and facilitation.
- Strong project management and organizational skills; ability to manage challenging, high-value projects.
- Initiative and creativity in solving complex problems and improving cross-functional processes.
Education and Experience:
- Bachelor’s degree in relevant discipline.
- Ph.D. (or equivalent degree).
- Typically requires 6 years of experience or equivalent combination of education and experience.
- The Medical Writing Science Senior Manager independently authors 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 sections of marketing authorization applications) with key stakeholders.
- Serve as lead Medical Writing Scientist for complex/pivotal clinical studies across multiple programs/therapeutic areas.
- Provide expert review of study-level and program-level documents.
- Develop key messages for complex clinical regulatory documents.
- Provide leadership on teams defining direction and regulatory strategy for clinical development programs.
- Contribute strategic/scientific input to regulatory documentation for the clinical development pipeline.
- Contribute to advisory committee presentation content; may prepare briefing documents.
- Ensure document preparation complies with company and industry standards.
- Contribute to cross-functional teams on SOPs, process improvements, and integration of new tools/technologies.
Knowledge and Skills:
- Outstanding written and oral communication skills.
- 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 through negotiation and facilitation.
- Strong project management and organizational skills; ability to manage challenging, high-value projects.
- Initiative and creativity in solving complex problems and improving cross-functional processes.
Education and Experience:
- Bachelor’s degree in relevant discipline.
- Ph.D. (or equivalent degree).
- Typically requires 6 years of experience or equivalent combination of education and experience.