Senior Medical Writing Lead - Regulatory

Regulatory Toolkit; Boston (MA); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

Generous paid time off

Commuting subsidy

401(k) matching

Job summary

Vertex is seeking a Medical Writing Science Manager to prepare moderately complex clinical and regulatory documents and to represent Medical Writing Science as a cross-functional team member at clinical study level activities.

You will lead the Medical Writing Scientist for moderately complex clinical studies, review data with the Medical Lead, and contribute to product development plans, ensuring accuracy and consistency across documents. Hybrid-eligible role with on-site flexibility.

Qualifications

• Ph.D. (or equivalent) degree.
• 4+ years of experience in a related role or equivalent combination of education and experience.

Responsibilities

• Authors clinical regulatory documents in partnership with cross-functional stakeholders.
• LeadsMedical Writing Scientist for moderately complex studies.
• Supports review and interpretation of study data for questions from the study team.
• Develops key messages for regulatory documents.
• Ensures consistency across related documents and studies.

Skills

Written communication

Data interpretation

Project management

Regulatory knowledge

Cross-functional collaboration

Scientific writing

Education

Ph.D. (or equivalent)

Tools

Word processing

Review systems

Job description

Vertex is seeking a Medical Writing Science Manager to prepare moderately complex clinical and regulatory documents and to represent Medical Writing Science as a cross-functional team member at clinical study level activities.

You will lead the Medical Writing Scientist for moderately complex clinical studies, review data with the Medical Lead, and contribute to product development plans, ensuring accuracy and consistency across documents. Hybrid-eligible role with on-site flexibility.