Senior Manager – Medical Writing Delivery & Excellence

The Role:

The Senior Manager of Medical Writing Delivery & Excellence is a high-impact role that demands a dynamic blend of expertise in traditional medical writing operations, process innovation, and full-cycle document stewardship. Reporting directly to the Senior Director of Medical Writing Delivery & Excellence, the chosen individual will drive the development and adoption of cutting-edge processes to enhance practices within medical writing and clinical trial transparency departments.

Here’s What You’ll Do:

• Functional Knowledge: Apply an in-depth understanding of concepts, theories, and principles of medical writing operations and regulatory submission process.

• Project Management: Oversee the timely and efficient progress of medical writing deliverables, ensuring that all deadlines are met.

• Cross-functional Collaboration: Work closely with cross-functional teams to ensure alignment and integration of clinical and regulatory documents.

• Regulatory Compliance: Ensure that the content and format of clinical and regulatory documents complies with applicable submission formatting regulations.

• Line Management: Typically manages the daily activities of multiple supervised groups (if applicable); adapts functional plans and priorities to meet short-term service and/or operational objectives.

• Problem Solving: Identify and resolve technical and operational problems, understanding and recognizing their broader impact on the department.

• Impact: Impacts a range of internal operational, project, or program activities within own team and other related teams; works within broad guidelines and policies.

• Develop and Implement Departmental Strategies: Provide input into goals and objectives for the medical writing operations team that align with the medical writing and company's overall strategy.

Here’s What You’ll Bring to the Table:

• Education and Years of Experience: Advanced degree (preferred) with approximately 4 years of relevant experience OR bachelor’s degree with approximately 8 years of relevant experience.

• Excellent interpersonal skills, with the ability to build strong relationships and work collaboratively with internal and external stakeholders to build consensus.

• Leadership Skills: Demonstrated leadership and team management abilities. May lead functional projects or programs. Mentors and collaborates with colleagues with less experience.

• Business Expertise: Strong business acumen, with a clear understanding of the impact of the medical writing team's work on the broader business objectives.

• Quality: Commitment to quality, ensuring that all work produced meets the highest standards of accuracy and comprehensiveness. High attention to detail, organizational skills, and the ability to manage multiple tasks simultaneously.

• Technical skills: Strong understanding of the technical aspects of the job. Proficiency in the use of standard industry software and tools.

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• 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
• Location-specific perks and extras!

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.