Medical Writing Manager (Hybrid)
Vertex Pharmaceuticals
June 27, 2026
Remote friendly (Boston, MA)
United States
Clinical Research and Development
General Summary:
The Medical Writing Science Manager is responsible for preparing moderately complex clinical and regulatory documents and represents Medical Writing Science as a cross-functional team member at clinical study level activities.
Key Duties and Responsibilities:
- Authors moderately complex clinical regulatory documents (e.g., clinical study protocols, clinical study reports, investigator’s brochures, and sections of regulatory submissions) with cross-functional stakeholders
- Serves as the lead Medical Writing Scientist for moderately complex clinical studies
- Supports Medical Lead with review/interpretation of clinical study data and study team questions
- Develops key messages for moderately complex clinical regulatory documents
- Ensures medical and scientific consistency between related documents/studies in a clinical program
- Analyzes and interprets data to determine best approach to composing each document
- Contributes to product development plans (providing prior study information, scientific input, integrating/reviewing data) and serves as coordinating author
- Participates in developing standard operating processes and related procedures
Knowledge and Skills:
- Superior written and oral communication skills
- Experience writing and editing clinical regulatory documents
- Ability to analyze, interpret, and summarize moderately complex data
- Broad understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology
- Ability to manage project teams, build relationships, and work through conflicts
- Excellent project management and organizational skills
- Self-sufficient, resourceful approach with guidance/mentoring as needed
- Initiative/creativity in solving problems affecting multiple documents and improving cross-functional processes
- Advanced computer skills (word processing, templates, table/figure creation, literature searches, electronic review systems, document management systems)
Education and Experience:
- Ph.D. (or equivalent degree)
- Typically 4 years of experience or equivalent education/experience
Pay/Benefits/Flex/Company legal text removed.
The Medical Writing Science Manager is responsible for preparing moderately complex clinical and regulatory documents and represents Medical Writing Science as a cross-functional team member at clinical study level activities.
Key Duties and Responsibilities:
- Authors moderately complex clinical regulatory documents (e.g., clinical study protocols, clinical study reports, investigator’s brochures, and sections of regulatory submissions) with cross-functional stakeholders
- Serves as the lead Medical Writing Scientist for moderately complex clinical studies
- Supports Medical Lead with review/interpretation of clinical study data and study team questions
- Develops key messages for moderately complex clinical regulatory documents
- Ensures medical and scientific consistency between related documents/studies in a clinical program
- Analyzes and interprets data to determine best approach to composing each document
- Contributes to product development plans (providing prior study information, scientific input, integrating/reviewing data) and serves as coordinating author
- Participates in developing standard operating processes and related procedures
Knowledge and Skills:
- Superior written and oral communication skills
- Experience writing and editing clinical regulatory documents
- Ability to analyze, interpret, and summarize moderately complex data
- Broad understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology
- Ability to manage project teams, build relationships, and work through conflicts
- Excellent project management and organizational skills
- Self-sufficient, resourceful approach with guidance/mentoring as needed
- Initiative/creativity in solving problems affecting multiple documents and improving cross-functional processes
- Advanced computer skills (word processing, templates, table/figure creation, literature searches, electronic review systems, document management systems)
Education and Experience:
- Ph.D. (or equivalent degree)
- Typically 4 years of experience or equivalent education/experience
Pay/Benefits/Flex/Company legal text removed.