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Senior Manager of Medical Writing and Regulatory Affairs

2 months ago

Cambridge, Massachusetts, United States Moderna Therapeutics Full time
About the Role

The Senior Manager of Medical Writing and Regulatory Affairs is a critical position within our Clinical Development team at Moderna Therapeutics. Reporting directly to the Associate Director, Director of Medical Writing, or Senior Director of Medical Writing, this individual will play a pivotal role in delivering high-quality clinical and regulatory writing, from planning and coordination to final drafts.

Key Responsibilities
  • Functional Knowledge: Apply in-depth conceptual and practical knowledge of medical writing and regulatory writing concepts, theories, and principles within a clinical development program.
  • Document Planning: Develop and manage comprehensive, strategic document plans for clinical and regulatory submissions.
  • Project Management: Oversee the timely and efficient progress of medical writing deliverables, ensuring all deadlines are met.
  • Cross-Functional Collaboration: Work closely with cross-functional teams to ensure alignment and integration of clinical and regulatory documents.
  • Regulatory Compliance: Ensure all written documents comply with regulatory, industry, and corporate guidelines and standards.
  • Data Interpretation: Interpret and present clinical data and other complex information.
  • Quality Control: Implement and oversee quality control processes for writing and reviewing clinical and regulatory documents.
  • Document Updates: Regularly update and revise documents as necessary to reflect current information and meet regulatory requirements.
  • Problem Solving: Solve complex problems; take a new perspective on existing solutions; exercise judgment based on the analysis of multiple sources of information.
Requirements
  • Education: Advanced degree (preferred) with a minimum of 4 years of relevant experience OR bachelors degree with a minimum of 9 years of relevant experience.
  • Industry Experience: Proven experience in clinical development, regulatory affairs, or medical affairs.
  • Industry Experience: Proven experience in writing and editing clinical and regulatory documents for submission to global regulatory authorities.
  • Interpersonal Skills: Excellent interpersonal skills, with the ability to guide others either internally with other areas or externally with vendors and cross-functional team members to adopt a different point of view.
  • Leadership Skills: Ability to manage the daily activities of multiple supervised individuals; adapt functional plans and priorities to meet short-term service and/or operational objectives.
  • Business Expertise: Knowledge of best practices and how medical writing integrates with others within organization sub-function; is aware of the competition and the factors that differentiate them in the market.
  • Communication Skills: Exceptional written and verbal communication skills, with the ability to clearly convey complex scientific information.
  • Quality: Commitment to quality, ensuring that all work produced meets the highest standards of accuracy and comprehensiveness.