Medical Writing Science Manager

Hybrid role based in Boston, MA with a 2-month initial duration.

About the Role

The Medical Writing Science Manager prepares moderately complex clinical and regulatory documents and serves as a cross-functional team member for clinical study-level activities. This role applies scientific knowledge and analytical skills to develop clinical regulatory documentation with minimal supervision.

Responsibilities

• Authors moderately complex clinical regulatory documents (e.g., 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 the Medical Lead with review and interpretation of clinical study data and addresses 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., provides information from previous studies, scientific input, and integrates and reviews data) and serves as coordinating author for product development plans.
• Participates in developing standard operating processes and related procedures.

Qualifications

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

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 processes.
• 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.