Medical Writing Science Senior Manager (Hybrid)
Vertex Pharmaceuticals
August 30, 2026
Remote friendly (Boston, MA)
United States
Clinical Research and Development
General Summary:
The Medical Writing Science Senior Manager is responsible for independently authoring 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 agency 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 or therapeutic areas
- Provide expert review of study-level and program-level documents
- Develop key messages for complex clinical regulatory documents
- Lead teams defining direction and regulatory strategy for a clinical development program
- Provide strategic and scientific contributions to regulatory documentation for 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 new tools/technologies
Knowledge And Skills:
- Outstanding written and oral communication skills
- Extensive experience writing/editing clinical regulatory documents
- Ability to analyze/interpret/summarize highly complex data
- Advanced understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology
- Conflict mediation 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
Pay/Benefits (as stated):
- Annual bonus and annual equity awards; base pay range: $137,200–$205,800
- Benefits include medical, dental, vision, paid time off (including week-long shutdowns in Summer and Winter), educational assistance/student loan repayment, commuting subsidy, matching charitable donations, and 401(k).
The Medical Writing Science Senior Manager is responsible for independently authoring 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 agency 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 or therapeutic areas
- Provide expert review of study-level and program-level documents
- Develop key messages for complex clinical regulatory documents
- Lead teams defining direction and regulatory strategy for a clinical development program
- Provide strategic and scientific contributions to regulatory documentation for 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 new tools/technologies
Knowledge And Skills:
- Outstanding written and oral communication skills
- Extensive experience writing/editing clinical regulatory documents
- Ability to analyze/interpret/summarize highly complex data
- Advanced understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology
- Conflict mediation 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
Pay/Benefits (as stated):
- Annual bonus and annual equity awards; base pay range: $137,200–$205,800
- Benefits include medical, dental, vision, paid time off (including week-long shutdowns in Summer and Winter), educational assistance/student loan repayment, commuting subsidy, matching charitable donations, and 401(k).