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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 senior management and is responsible for producing high-quality 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 timely production of superior writing
- Collaborate effectively with interdisciplinary teams
- Ensure adherence to regulatory standards
- Analyze clinical data for accurate interpretation
- Establish and execute quality assurance protocols
- Revise and enhance documents as necessary
- Contribute to departmental strategic planning
- Supervise and mentor 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 capabilities
- 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.
