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 is solidifying its presence within our international business services hub in Warsaw, Poland, a city renowned for its rich scientific and technological heritage. This hub provides critical functions meeting the growing demand of Moderna’s global business operations. We're inviting professionals from around the world to join our mission and contribute to the future of mRNA medicines.

In the position of Regulatory Operations Senior Publishing Specialist, you will be responsible for the planning, creation, and submission of regulatory submissions. Collaborating with the Regulatory Lead, you will prepare high-quality global submissions, whether in-house or via CRO, ensuring their timely delivery to global health authorities. You will provide regulatory operations expertise to cross-functional submission project teams, enhancing the planning, preparation, and delivery of regulatory submissions. Acting as the primary contact for daily submissions for major projects, you will embody Moderna’s commitment to urgency and ownership in delivering transformative medicines to patients.

Here's What You’ll Bring To The Table

Your key responsibilities will be:

• Compile, publish, and verify submission dossiers in accordance with international eCTD requirements and regulatory guidelines.
• Lead the submission of MAA, INDs, NDAs, BLAs, Master Files, and other regulatory documents.
• Work closely with team members to compile documents, review hypertext links, ensure PDFs are submission-ready, format tables and graphics, bookmark sections, and proof submissions according to internal standards.
• Develop new processes and procedures to enhance efficiency and accuracy during the submission process.
• Collaborate with submissions management to build technically valid and high-quality dossiers.
  
  

Your Responsibilities Will Also Include

• Manage the submission of eCTD sequences through health authority gateways.
• Perform quality control (QC) of documents published by other team members to ensure compliance with applicable guidance documents.
• Assist with the remediation of Word documents to ensure proper format and compliance.
• Mentor and train other team members to increase the quality across the team.
• Participate in internal and external audits, maintaining compliance with department systems, e.g., project database, timesheets, training.
• Contribute to the development of new publishing services and actively participate in department initiatives and process improvements.
• Maintain a strong understanding of applicable regulatory guidelines and ensure the achievement of individual utilization targets.
  
  

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

• We act with urgency: Your role in ensuring timely and accurate submissions is critical to meeting regulatory deadlines.
• We prioritize the platform: Leveraging digital tools and systems will enhance submission efficiency and accuracy.
  
  

Here’s What You’ll Bring To The Table

• A Bachelor’s degree or equivalent.
• At least 5 years of experience as a regulatory Publisher in a pharmaceutical company or CRO.
• Experience leading the submission of MAA, INDs, NDAs, BLAs, Master Files, etc., formatted according to international eCTD requirements.
• Clinical report and global submission dossier publishing/compilation experience in the pharmaceutical or related industry.
• Experience with electronic clinical document publishing standards/formats and global regulatory submission publishing standards/formats (e.g., eCTD, EU CTR).
• Working knowledge of publishing tools (e.g., DXC, eCTD Xpress, Veeva), global submission validation tools, Document Management systems, Toolbox, HA electronic submission gateways, IRIS, CTIS, MS Office tools.
• Familiarity with global Clinical and Regulatory HA requirements (e.g., FDA, ICH, EMA, MENA region, CH, MHRA).
• Strong interpersonal and project management skills, with experience working in a complex, global cross-functional organization.
• Highly motivated, organized, and detail-oriented team player.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Ability to readily adjust to change in a fast-paced environment and multitask.
• Positive attitude and ability to effectively collaborate with peers, stakeholders, and cross-functional colleagues in a global team environment.
• Strong technical skills.
• Strong communication and business writing skills.
• Fluency in English.
  
  

Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.

We Recognize And Appreciate Your Diverse Needs And Interests And Do Our Best To Support You At Work And At Home With

• 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, and a discretionary year-end shutdown
• Educational resources
• Savings and investments
• 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 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. 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 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.