Senior Medical Writing Scientist & Regulatory Strategy Lead (Hybrid)

Vertex Pharmaceuticals Incorporated; Boston (MA); Hybrid; USD 137,000 - 206,000; Full time

Job summary

Vertex Pharmaceuticals Incorporated in Boston, MA is seeking a Medical Writing Science Senior Manager to author complex clinical study documents and contribute to regulatory submissions across development stages.

This hybrid role offers two remote days per week and three days in the Boston Fan Pier office, with leadership on cross-functional teams and strategic input to regulatory documents.

Qualifications

• Outstanding written and oral communication skills.
• Extensive experience writing and editing clinical regulatory documents.
• Ability to analyze, interpret, and summarize highly complex data.
• Advanced understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology.
• Ability to mediate conflicts by negotiating, compromising, persuading, and facilitating the open exchange of ideas and opinions.
• Highly developed project management and organizational skills.
• Ability to manage challenging, high-value projects.
• Initiative and creativity in solving complex problems; ability to have a substantial role in developing and implementing improvements in cross-functional processes.

Responsibilities

• Authors complex clinical regulatory documents in partnership with key stakeholders.
• Lead Medical Writing Scientist for complex or pivotal clinical studies for multiple programs or therapeutic areas.
• Provides expert review of study-level and program-level documents.
• Participates in developing key messages for complex clinical regulatory documents.
• Provides leadership on teams defining regulatory strategy for a development program.
• Contributes to regulatory documentation in support of the clinical development pipeline.
• Contributes to content and strategy of presentations for regulatory agency advisory committee meetings.
• Ensures document preparation is compliant with company and industry standards.
• Contributes to cross-functional SOPs and process improvements.

Skills

Written communication

Regulatory documents

Clinical writing

Data interpretation

Project management

Cross-functional collaboration

Strategic thinking

Leadership

Education

Bachelor's degree

Ph.D.

Job description

Vertex Pharmaceuticals Incorporated in Boston, MA is seeking a Medical Writing Science Senior Manager to author complex clinical study documents and contribute to regulatory submissions across development stages.

This hybrid role offers two remote days per week and three days in the Boston Fan Pier office, with leadership on cross-functional teams and strategic input to regulatory documents.