The Role
The Regulatory Operations Senior Publishing Specialist is responsible for the planning, creation, and submission of regulatory submissions. In collaboration with the Regulatory Lead, you will plan and prepare high-quality global submissions, in-house or via CRO, ensuring delivery of compliant submissions to global health authorities in a timely manner. The Senior Publishing Specialist provides regulatory operations expertise to cross-functional submission project teams, promoting and bringing excellence in planning, preparation, and delivery of regulatory submissions. You will act as the primary point of contact for daily submissions for major submissions. At Moderna, we act with urgency and behave like owners, reflecting our commitment to delivering transformative medicines to patients.
Here’s What You’ll Do:
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.
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.
Here’s What You’ll Bring to the Table:
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.
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)
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