Lead Medical Writing Scientist for Regulatory Clinical Docs

Vertex Pharmaceuticals; Boston (MA); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Hybrid-eligible Or On-Site Eligible

Hybrid-Eligible Or On-Site Eligible

Job summary

Vertex Pharmaceuticals 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. This role contributes scientific knowledge and analytical skills to the development of clinical regulatory documentation, under minimal supervision.

The position supports the lead with review of study data, develops key messages for regulatory documents,

Qualifications

• Ph.D. (or equivalent degree).
• Typically requires 4 years of experience or the equivalent combination of education and experience.
• Superior written and oral communication skills.
• 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 and form productive working relationships, and work through conflicts.
• Excellent project management and organizational skills.

Responsibilities

• Authors moderately complex clinical regulatory documents (e.g., including clinical study protocols, clinical study reports, investigator’s brochures, and sections of regulatory submissions) in partnership with key cross-functional stakeholders
• Serves as the lead Medical Writing Scientist for moderately complex clinical studies
• Supports Medical Lead with review and interpretation of clinical study data and addressing questions from study team members
• Participates in developing key messages for moderately complex clinical regulatory documents
• Ensures medical and scientific consistency between related documents or studies in a clinical program
• Analyzes and interprets data thoroughly and critically to determine the best approach to composing each document
• Contributes to product development plans (e.g., provide information from previous studies, provide scientific input, integrate and review data) and serves as coordinating author for product development plans
• Participates in developing standard operating processes and related procedures

Skills

Clinical writing

Regulatory documents

Data interpretation

Drug development knowledge

Project management

Cross-functional collaboration

Communication skills

Education

Ph.D. (or equivalent degree)

Job description

Vertex Pharmaceuticals 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. This role contributes scientific knowledge and analytical skills to the development of clinical regulatory documentation, under minimal supervision.

The position supports the lead with review of study data, develops key messages for regulatory documents,