Medical Writing Manager (Hybrid)

Vertex Pharmaceuticals•Boston, MA

3d•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