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Senior Medical Writing Manager

2 months ago


Cambridge, Massachusetts, United States Moderna Therapeutics Full time

Senior Manager of Medical Writing

The Senior Manager of Medical Writing plays a pivotal role within the clinical development division at Moderna Therapeutics. This position reports directly to upper management and is responsible for producing exceptional clinical and regulatory documentation that aligns with the overarching goals of the clinical development initiative.

Key Responsibilities:

  • Formulate and oversee documentation strategies for clinical and regulatory submissions
  • Guarantee the prompt delivery of superior writing
  • Engage with cross-disciplinary teams
  • Ensure adherence to regulatory standards
  • Analyze clinical data
  • Establish quality assurance protocols
  • Revise documentation as necessary
  • Contribute to departmental planning
  • Supervise direct reports

Qualifications:

  • Advanced degree preferred with a minimum of 4 years of relevant experience or a bachelor's degree with 9 years of experience
  • Background in clinical development, regulatory affairs, or medical writing
  • Demonstrated expertise in drafting clinical and regulatory documents
  • Exceptional interpersonal and leadership abilities
  • Proficient in Microsoft Office and medical writing applications
  • Strong verbal and written communication skills
  • Dedication to quality and meticulous attention to detail

Moderna Therapeutics provides a comprehensive benefits package and fosters a culture that prioritizes innovation and collaboration.