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Job Description

General Summary:

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. The position allows remote work 2 days per week, and requires 3 days per week in the Boston Fan Pier office.

Key Duties and 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

Knowledge and Skills:

• 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

Education and Experience:

• Ph.D. (or equivalent degree)
• Typically requires 4 years of experience or the equivalent combination of education and experience

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