Medical Writing Manager (Hybrid)
Vertex Pharmaceuticals
August 31, 2026
Remote friendly (Boston, MA)
United States
Clinical Research and Development
General Summary:
The Medical Writing Science Manager prepares moderately complex clinical and regulatory documents and represents Medical Writing Science as a cross-functional team member at clinical study activities. Contributes scientific knowledge and analytical skills to the development of clinical regulatory documentation under minimal supervision.
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 key cross-functional stakeholders
- Serves as lead Medical Writing Scientist for moderately complex clinical studies
- Supports Medical Lead with review/interpretation of clinical study data and answers 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 and serves as coordinating author
- Participates in developing standard operating processes and procedures
Knowledge And Skills:
- Superior written and oral communication; strong clinical regulatory writing/editing experience
- 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
- Project/team management, conflict resolution, and strong project management/organizational skills
- Resourceful, self-sufficient; initiative and creativity for improvements
- Advanced computer skills (word processing, templates, tables/figures, literature searches, electronic review systems, document management)
Education And Experience:
- Ph.D. (or equivalent degree)
- Typically requires 4 years of experience or equivalent education/experience
The Medical Writing Science Manager prepares moderately complex clinical and regulatory documents and represents Medical Writing Science as a cross-functional team member at clinical study activities. Contributes scientific knowledge and analytical skills to the development of clinical regulatory documentation under minimal supervision.
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 key cross-functional stakeholders
- Serves as lead Medical Writing Scientist for moderately complex clinical studies
- Supports Medical Lead with review/interpretation of clinical study data and answers 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 and serves as coordinating author
- Participates in developing standard operating processes and procedures
Knowledge And Skills:
- Superior written and oral communication; strong clinical regulatory writing/editing experience
- 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
- Project/team management, conflict resolution, and strong project management/organizational skills
- Resourceful, self-sufficient; initiative and creativity for improvements
- Advanced computer skills (word processing, templates, tables/figures, literature searches, electronic review systems, document management)
Education And Experience:
- Ph.D. (or equivalent degree)
- Typically requires 4 years of experience or equivalent education/experience