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Senior Manager Medical Writing Delivery & Excellence

Employer
Moderna, Inc.
Location
Cambridge, MA
Start date
Jun 13, 2024

View more

Discipline
Clinical, Medical Writing
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Genetown, Best Places to Work

Job Details

The Role:

The Senior Manager of Medical Writing Delivery & Excellence is a high-impact role that demands a dynamic blend of expertise in traditional medical writing operations, process innovation, and full-cycle document stewardship. Reporting directly to the Senior Director of Medical Writing Delivery & Excellence, the chosen individual will drive the development and adoption of cutting-edge processes to enhance practices within medical writing and clinical trial transparency departments.

Heres What Youll Do:

  • Functional Knowledge: Apply an in-depth understanding of concepts, theories, and principles of medical writing operations and regulatory submission process.

  • Project Management: Oversee the timely and efficient progress of medical writing deliverables, ensuring that all deadlines are met.

  • Cross-functional Collaboration: Work closely with cross-functional teams to ensure alignment and integration of clinical and regulatory documents.

  • Regulatory Compliance: Ensure that the content and format of clinical and regulatory documents complies with applicable submission formatting regulations.

  • Line Management: Typically manages the daily activities of multiple supervised groups (if applicable); adapts functional plans and priorities to meet short-term service and/or operational objectives.

  • Problem Solving: Identify and resolve technical and operational problems, understanding and recognizing their broader impact on the department.

  • Impact: Impacts a range of internal operational, project, or program activities within own team and other related teams; works within broad guidelines and policies.

  • Develop and Implement Departmental Strategies: Provide input into goals and objectives for the medical writing operations team that align with the medical writing and company's overall strategy.

Heres What Youll Bring to the Table:

  • Education and Years of Experience: Advanced degree (preferred) with approximately 4 years of relevant experience OR bachelors degree with approximately 8 years of relevant experience.

  • Excellent interpersonal skills, with the ability to build strong relationships and work collaboratively with internal and external stakeholders to build consensus.

  • Leadership Skills: Demonstrated leadership and team management abilities. May lead functional projects or programs. Mentors and collaborates with colleagues with less experience.

  • Business Expertise: Strong business acumen, with a clear understanding of the impact of the medical writing team's work on the broader business objectives.

  • Quality: Commitment to quality, ensuring that all work produced meets the highest standards of accuracy and comprehensiveness. 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.

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, theinfrastructure 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 peopleare 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. Were 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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Company

Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. Moderna’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.

mRNA is now a turning point in the history of science, medicine, technology, even humankind itself. With this breakthrough discovery, many of the world’s biggest and most challenging medical problems are no longer a question of “how?” but merely a question of “when?”

Come with us as we pursue the uncharted reaches of possibility and make your mark on the future of medicine.

 

Stock Symbol:

MRNA  

Stock Exchange:

USNASDAQ GS

 

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Company info
Website
Phone
617-714-6500
Location
200 Technology Square
Cambridge, MA
US

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