Senior Medical Writing Scientist - Regulatory Strategy Lead

Regulatory Toolkit; Boston (MA); Hybrid; USD 137,000 - 206,000; Full time

Job summary

Vertex is seeking a Medical Writing Science Senior Manager to independently author complex clinical study documents and regulatory submission sections across all phases of drug development. This hybrid role accommodates two days remote and three days in Boston Fan Pier.

The successful candidate will lead writing for studies, review regulatory content, and guide regulatory strategy across programs, with extensive collaboration across cross-functional teams and advisory committee materials as

Qualifications

• Bachelor's degree in relevant discipline.
• Ph.D. (or equivalent degree).
• Typically requires 6 years of experience or the equivalent combination of education and experience.

Responsibilities

• Authors complex clinical regulatory documents in partnership with stakeholders.
• Leads medical writing science for complex studies across programs.
• Reviews study-level and program-level documents for accuracy.
• Develops key messages for regulatory documents.
• Provides regulatory strategy direction for clinical development programs.
• Contributes to content and strategy of regulatory presentations.

Skills

Regulatory writing

Clinical documents

Regulatory submissions

Cross-functional teamwork

Leadership

Project management

Scientific communication

Data interpretation

Education

Bachelor's degree

Ph.D. (or equivalent)

Experience: 6+ years

Job description

Vertex is seeking a Medical Writing Science Senior Manager to independently author complex clinical study documents and regulatory submission sections across all phases of drug development. This hybrid role accommodates two days remote and three days in Boston Fan Pier.

The successful candidate will lead writing for studies, review regulatory content, and guide regulatory strategy across programs, with extensive collaboration across cross-functional teams and advisory committee materials as