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Senior Manager of Medical Writing Excellence
2 months ago
We 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 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
- Regularly update and revise documents as necessary to reflect current information and meet regulatory requirements
- 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 and explain complex information
- Ability to manage the daily activities of multiple supervised individuals and adapt functional plans and priorities
- Knowledge of best practices and how medical writing integrates with others within the organization
- 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
- Generous paid time off, including vacation, sick time, and holidays
- Discretionary year-end shutdown
- 401k match and Financial Planning tools
- Moderna-paid Life, LTD, and STD insurance coverages, as well as voluntary benefit options
Moderna is a leading biotechnology company that is pioneering the use of mRNA technology to create innovative medicines. We are committed to making a meaningful impact on the lives of patients and are seeking talented individuals to join our team.
