Senior Manager of Medical Writing Delivery and Excellence

4 weeks ago


Cambridge, Massachusetts, United States Moderna Therapeutics Full time
Role Overview

The Senior Manager of Medical Writing Delivery and Excellence is a critical role that requires a high level of expertise in medical writing and regulatory affairs. As a key member of the clinical development team, you will be responsible for delivering high-quality clinical and regulatory writing, from planning and coordination to final draft delivery.

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

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

What We Offer

* 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 to participate within your community
* Discretionary year-end shutdown
* Paid sabbatical after 5 years; every 3 years thereafter
* Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
* 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
* Free parking or subsidized commuter passes

About Moderna

Moderna is a leading biotechnology company that is pioneering the development of messenger RNA (mRNA) therapeutics and vaccines. We are committed to revolutionizing the field of medicine and improving the lives of patients worldwide. Our team is passionate about innovation, collaboration, and making a meaningful impact. If you are a motivated and talented individual who shares our vision, we encourage you to apply for this exciting opportunity.

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