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Senior Medical Writing Manager
2 months ago
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 document 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
- Modify documents 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 relevant experience
- Background in clinical development, regulatory affairs, or medical writing
- Demonstrated experience 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.
