Senior Manager of Medical Writing
2 weeks ago
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
- 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
- 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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Senior Manager of Medical Writing
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Senior Manager of Medical Writing Excellence
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Cambridge, Massachusetts, United States Moderna Therapeutics Full timeAbout the RoleWe are seeking a highly skilled Senior Manager of Medical Writing Delivery and Excellence to join our Clinical Development team at Moderna Therapeutics. As a key member of our team, you will be responsible for delivering high-quality clinical and regulatory writing, from planning and coordination to final drafts.Key ResponsibilitiesDevelop and...
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