Senior Manager of Medical Writing

2 weeks ago


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

Moderna Therapeutics is seeking a highly skilled Senior Manager of Medical Writing to join our Clinical Development team. As a key member of our team, you will be responsible for leading the development of high-quality clinical and regulatory documents, ensuring compliance with regulatory guidelines and industry standards.

Key Responsibilities
  • Develop and manage comprehensive document plans for clinical and regulatory submissions
  • Oversee the timely and efficient progress of medical writing deliverables, ensuring all deadlines are met
  • Collaborate with cross-functional teams to ensure alignment and integration of clinical and regulatory documents
  • Ensure all written documents comply with regulatory, industry, and corporate guidelines and standards
  • Interpret and present clinical data and other complex information
  • Implement and oversee quality control processes for writing and reviewing clinical and regulatory documents
  • Develop and implement departmental strategies to align with the company's overall strategy
Requirements
  • Advanced degree (preferred) with a minimum of 4 years of relevant experience OR bachelors degree with a minimum of 9 years of relevant experience
  • Proven experience in clinical development, regulatory affairs, or medical affairs
  • Proven experience in writing and editing clinical and regulatory documents for submission to global regulatory authorities
  • Excellent interpersonal skills, with the ability to guide others either internally with other areas or externally with vendors and cross-functional team members
  • Ability to manage the daily activities of multiple supervised individuals
  • Knowledge of best practices and how medical writing integrates with others within organization sub-function
What We Offer
  • Highly competitive and inclusive medical, dental and vision coverage options
  • Flexible Spending Accounts for medical expenses and dependent care expenses
  • Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
  • Family care benefits, including subsidized back-up care options and on-demand tutoring
  • Free premium access to fitness, nutrition, and mindfulness classes
  • Exclusive preferred pricing on Peloton fitness equipment
  • Adoption and family-planning benefits
  • Dedicated care coordination support for our LGBTQ+ community
  • Generous paid time off, including vacation, sick time and holidays, volunteer time, discretionary year-end shutdown, and paid sabbatical
  • 401k match and Financial Planning tools
  • Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
  • Complimentary concierge service including home services research, travel booking, and entertainment requests


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