Medical Writing Science Manager

Key Duties and Responsibilities Authors moderately complex clinical regulatory documents, including clinical study protocols, clinical study reports, investigator’s brochures, and sections of regulatory submissions, in partnership with key cross-functional stakeholders. Advanced computer skills related to word processing, templates, table and figure creation, literature searches, electronic review systems, and document management systems; ability to serve as a resource for others using these tools.

Position: Medical Writing Science Manager
Contract: 2+ Month Contract with Potential to Extend or Convert
Location: Hybrid 3 days/week in Boston, MA
 
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 the clinical study level. This role contributes scientific knowledge and analytical skills to the development of clinical and regulatory documentation, under minimal supervision.
 
Key Duties and Responsibilities

• Authors moderately complex clinical regulatory documents, 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 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 and studies within a clinical program.
• Analyzes and interprets data thoroughly and critically to determine the best approach to composing each document.
• Contributes to product development plans by providing information from previous studies, scientific input, and data integration and review.
• 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 develop 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 identifying and contributing to improvements in cross-functional processes.
• Advanced computer skills related to word processing, templates, table and figure creation, literature searches, electronic review systems, and document management systems; ability to serve as a resource for others using these tools.

 
Education and Experience

• Ph.D. or equivalent advanced degree.
• Typically requires 4 years of relevant experience or an equivalent combination of education and experience.