Manager, Medical Writing Delivery and Excellence

Joining Moderna offers the unique opportunity to be part of a pioneering team that is revolutionising medicine through mRNA technology with a diverse pipeline of development programmes across various diseases. As an employee, you will be part of a continually growing organisation 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 are looking for global experts eager to join us in this endeavour, 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:

• Lead the development, coordination, and delivery of high-quality clinical and regulatory documents, ensuring compliance with global standards.
• Implement quality control processes to review and refine clinical and regulatory documents before submission.
• Ensure alignment with regulatory requirements and industry best practices to support clinical development programmes.
• Manage external vendors and consultants, overseeing contract negotiations and quality assurance of their work.
• Develop standardised templates and style guides to maintain consistency in medical writing outputs.
• Provide training and mentorship to team members to enhance skills and industry knowledge.
• Collaborate with cross-functional teams, ensuring integration of medical writing deliverables with broader project timelines and objectives.
• Maintain and oversee the budget for the medical writing department, ensuring cost-effective resource allocation.
• Stay informed of industry trends and regulatory changes to continuously refine medical writing processes and strategies.

Your responsibilities will also include:

• Solving problems by identifying and implementing effective solutions, applying technical expertise, and following best practices.
• Contributing to a high-performance culture, ensuring clear communication of expectations, and addressing challenges proactively.
• Supporting ongoing improvements in document management and workflow optimisation to increase efficiency and reduce turnaround times.

The key Moderna Mindsets you’ll need to succeed in the role:

• We obsess over learning – The field of medical writing is ever-evolving, and staying ahead of regulatory changes, best practices, and technology advancements will be critical to success. You will bring a strong curiosity and dedication to continuous learning, ensuring that Moderna remains at the forefront of medical writing excellence.
• We behave like owners – As a key contributor to the regulatory and clinical writing process, you will take full ownership of projects, ensuring the highest quality standards, timely delivery, and alignment with Moderna’s broader mission to transform medicine.

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: Strong commitment to quality and attention to detail.
• Technical skills: Proficiency in medical writing software and a strong understanding of the technical aspects of the job (quality control and medical writing). Proficiency in the use of standard industry software and tools.

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
• 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 organisation that cares deeply for our patients, our employees, the environment, and our communities.

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 committed to equal opportunity in employment and non-discrimination for all employees and qualified applicants without regard to a person's race, colour, 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.