Senior Medical Writing Manager

2 weeks 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 high-caliber clinical and regulatory documentation that aligns with the overarching goals of the clinical development initiatives.

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 procedures
  • Modify documents as necessary
  • Contribute to departmental planning
  • Supervise direct reports

Qualifications:

  • Preferred advanced degree 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 crafting 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.



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