Manager, Document Quality & Compliance of Medical Writing Delivery & Excellence

The Role: Joining Moderna offers the unique opportunity to be part of a pioneering team that\’s revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you\’ll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna\’s commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients\’ lives worldwide. Moderna\’s mission is to establish a leading-edge research, development, and manufacturing facility at Harwell, as part of a long-term commitment to onshore mRNA vaccine production for respiratory diseases. This initiative will create a multitude of highly skilled jobs and foster collaboration with academic, NHS, and government partners across the UK. We\’re looking for global experts eager to join us in this endeavor, contributing to a future where access to life-saving vaccines is a reality for all. Here’s What You’ll Do: Your key responsibilities will be: Develop and implement departmental strategies, setting goals and objectives for the Medical Writing Delivery & Excellence team in alignment with Moderna’s overarching business strategy. Oversee medical writing documentation and processes to ensure compliance with regulatory, industry, and corporate standards. Support cross-functional communication, internal and external resourcing, and quality control processes for clinical and regulatory documents. Design and enhance tools aligned with standardized templates and style guides to improve efficiency and document consistency across the team. Provide training and mentorship to team members, fostering a culture of excellence and continuous improvement. Engage in cross-functional collaboration, ensuring that Medical Writing Delivery & Excellence’s outputs align with broader business objectives. Solve complex problems by identifying and selecting appropriate solutions, leveraging technical expertise and industry best practices. Contribute to the team\’s overall efficiency and effectiveness by setting clear performance expectations and handling sensitive issues with professionalism. Your responsibilities will also include: Staying current on regulatory requirements and medical writing best practices to ensure Moderna’s documentation remains inspection-ready. Supporting process improvements and change management initiatives within the Medical Writing and Clinical Trial Transparency functions. Driving the adoption of digital tools to enhance efficiency and streamline medical writing operations, including Veeva and other industry-standard platforms. Ensuring that documentation workflows are aligned with Moderna’s high standards of quality and compliance. The key Moderna Mindsets you’ll need to succeed in the role: We obsess over learning – The medical writing landscape is evolving rapidly, requiring professionals who can adapt, learn quickly, and integrate new technologies into their workflow. This role demands a mindset focused on continuous improvement, training, and mentorship to ensure the team remains ahead of industry changes. We digitize everywhere possible – In a data-driven and highly regulated environment, leveraging digital tools is crucial. This role will support the integration of digital solutions such as Veeva to streamline document management and improve operational efficiencies in the Medical Writing Delivery & Excellence function. Here’s What You’ll Bring to the Table: Education and Years of Experience: Advanced degree (preferred) with approximately 3 years of relevant experience OR bachelor’s degree with approximately 8 years of relevant experience. Interpersonal Skills: Ability to exchange complex information with others in difficult situations. May be required to guide and convince others. Leadership Skills: Ability to mentor junior members of the team (if applicable). Business Expertise: Understanding of how own team integrates with others in accomplishing medical writing objectives. Quality: Committed to quality with 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 (including Veeva). This role is expected to be in office 70% of the time with flexibility to work from home up to 30%. At Moderna, we believe that when you feel your best, you can do your best work. That’s why our global benefits and well-being resources are designed to support you—at work, at home, and everywhere in between. Quality healthcare and insurance benefits Lifestyle Spending Accounts to create your own pathway to well-being Free premium access to fitness, nutrition, and mindfulness classes Family planning and adoption benefits Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown Savingsandinvestments Location-specific perks and extras! The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work. 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 committed to equal opportunity in employment 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. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment 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 and Adjustments team at leavesandaccommodations@modernatx.com . #LI-JP1 – #J-18808-Ljbffr