The Senior Manager of Medical Writing Delivery and Excellence is a high-impact role, reporting directly to the Senior Director of Medical Writing Delivery and Excellence. The chosen individual will not just be responsible for, but will excel in delivering high-quality clinical and regulatory writing, from the meticulous planning and coordination stage to the delivery of the polished final drafts. As our Senior Manager of Medical Writing Delivery and Excellence, you will be more than a team member - you will be a crucial pivot in our clinical development team, deeply understanding and appreciating how your work significantly influences the broader objectives of our clinical development program.
Here's What You'll Do:
Functional Knowledge: Apply an in-depth conceptual and practical knowledge of concepts, theories, and principles of medical writing and regulatory writing within a clinical development program.
Document Planning: Develop and manage comprehensive, strategic document plans for clinical and regulatory submissions.
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 all written documents comply with regulatory, industry, and corporate guidelines and standards.
Data Interpretation: Interpret and present clinical data and other complex information.
Quality Control: Implement and oversee quality control processes for writing and reviewing clinical and regulatory documents.
Document Updates: Regularly update and revise documents as necessary to reflect current information and meet regulatory requirements.
Problem Solving: Solve complex problems; take a new perspective on existing solutions; exercise judgment based on the analysis of multiple sources of information.
Impact: Solve complex problems; take a new perspective on existing solutions; exercise judgment based on the analysis of multiple sources of information.
Develop and Implement Departmental Strategies: Provide input into goals and objectives for the medical writing team that align with the company's overall strategy.
Line Management: Responsible for management of direct reports (if applicable)
Here's What You'll Bring to the Table:
Education: Advanced degree (preferred) with a minimum of 4 years of relevant experience OR bachelors degree with a minimum of 9 years of relevant experience.
Industry Experience: Proven experience in clinical development, regulatory affairs, or medical affairs.
Industry Experience: Proven experience in writing and editing clinical and regulatory documents for submission to global regulatory authorities.
Interpersonal Skills: Excellent interpersonal skills, with the ability to guide others either internally with other areas or externally with vendors and cross-functional team members to adopt a different point of view. Ability to explain difficult or sensitive information; work to build consensus
Leadership Skills: Ability to manage the daily activities of multiple supervised individuals; adapt functional plans and priorities to meet short-term service and/or operational objectives. Ability to lead functional projects or programs; Mentor and collaborate with colleagues with less experience
Business Expertise: Knowledge of best practices and how medical writing integrates with others within organization sub-function; is aware of the competition and the factors that differentiate them in the market.
Communication Skills: Exceptional written and verbal communication skills, with the ability to clearly convey complex scientific information.
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: Proficiency in Microsoft Office and familiarity with medical writing software.
This role is based in our new LEED-certified HQ in Cambridge, MA and is expected to be in office 70% of the time with flexibility to work from home up to 30%.
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.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
