Manager, Document Quality & Compliance of Medical Writing Delivery & Excellence at ModernaTX, Inc. in Boston, Massachusetts

Job Description:

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.


The Manager, Document Quality & Compliance of Medical Writing Delivery & Excellence plays a pivotal role in ensuring that all aspects of medical writing operations meet the highest standards of quality, compliance, and efficiency. Reporting to the Senior Manager or Senior Director, this role is critical to advancing innovative processes and ensuring inspection readiness within the medical writing and clinical trial transparency teams.



Here's What You'll Do:

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  Your key responsibilities will be:
  
  
  


• Applying medical writing operations procedures and concepts for document management and quality control review.
  
  


• Developing and implementing departmental strategies that align with Moderna's medical writing and organizational goals.
  
  


• Monitoring documentation and processes for compliance with regulatory, industry, and corporate guidelines.
  
  


• Assisting with resource allocation, cross-team communication, and quality control processes for clinical and regulatory documents.
  
  


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  Your responsibilities will also include:
  
  
  


• Creating tools compatible with templates and style guides to drive efficiency and consistency.
  
  


• Providing training and mentorship to team members to foster skill development and adherence to best practices.
  
  


• Participating in cross-functional teams to align medical writing objectives with broader company needs.
  
  


• Solving complex problems through technical expertise and innovative solutions.
  
  


• Supporting a culture of excellence by fostering clear communication and promoting a high-performance ethos.
  
  


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


• 
  We obsess over learning: This role requires rapid adaptation to new technologies, regulatory requirements, and best practices in medical writing and document management to continuously elevate the quality of deliverables.
  
  


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  We prioritize the platform: A deep understanding of how document quality and compliance integrate with the broader goals of Moderna's medical writing and clinical transparency platform is essential.
  
  

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%.
  
  

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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