Medical Writing Science Manager

Position: Medical Writing Science ManagerContract: 2+ Month Contract with Potential to Extend or ConvertLocation: Hybrid 3 days/week in Boston, MAGeneral 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.