Medical Writing Manager (Hybrid)

Vertex Pharmaceuticals, Inc • Boston, MA

46d • Hybrid

About The Position

The Medical Writing Science Manager is responsible for preparing moderately complex clinical and regulatory documents and represents 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.

Requirements

• Superior written and oral communication skills
• Experience writing and editing clinical regulatory documents
• 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, form productive working relationships, and work through conflicts
• Excellent project management and organizational skills
• Ability to complete work in a resourceful, self-sufficient manner and design alternative approaches to achieve desired results, with some guidance and mentoring on new or complex issues
• Initiative and creativity in solving routine problems that affect multiple documents and in identifying and contributing to improvements in cross-functional process
• Advanced computer skills related to word processing, templates, table/figure creation, literature searches, electronic review systems, and document management systems; can act as a resource for others for these tools
• Ph.D. (or equivalent degree)
• Typically requires 4 years of experience or the equivalent combination of education and experience

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

Benefits

• This role is eligible for an annual bonus and annual equity awards.
• Some roles may also be eligible for overtime pay, in accordance with federal and state requirements.
• inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.
• From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Industry: Chemical Manufacturing
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees