The Manager of CTTD is a key role within our organization, reporting directly to the Director of CTTD. This position is responsible for managing the development and delivery of high-quality clinical and regulatory documents, from planning and coordination to the final draft. The individual in this role will work closely with the clinical development team, understanding and applying Disclosure procedures and concepts to process study details that support the broader objectives of our clinical development programs.
Here's What You'll Do:
Functional Knowledge: Understand and apply CTTD procedures and concepts for developing documents within a clinical development program. This includes but is not limited to:
Develop and implement departmental strategies: This includes setting goals and objectives for the CTTD team that align with the company's overall strategy.
Ensure compliance with regulatory guidelines: The Manager of CTTD should be responsible for ensuring that all documents produced by the team comply with international regulatory guidelines and standards.
Manage external vendors and consultants: This might include selecting vendors, managing contracts, and overseeing the quality of their work.
Develop templates: This can help ensure consistency across all submission documents produced by the CTTD team.
Provide training and mentorship to team members: The Manager of CTTD should be responsible for developing the skills and knowledge of their team members.
Participate in cross-functional teams: This can help ensure that the CTTD work aligns with the needs of other teams within the company.
Work within the established budget for the CTTD department: This includes planning the budget and monitoring expenses to ensure that the department stays within its budget.
Stay up-to-date with industry trends and changes in regulatory guidelines: This can help ensure that the medical writing team's work remains current and compliant.
Problem Solving: Solve problems by identifying and selecting solutions through the application of acquired technical experience, guided by precedents.
Impact: Contribute to the overall efficiency and effectiveness of the team, through clear communication of performance expectations, handling sensitive issues, and fostering a high-performance culture.
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 and Communication Skills: Excellent written, verbal, interpersonal, analytical, and communication skills to effectively communicate and collaborate with all levels of the organization. Ability to interpret scientific content, prioritize multiple projects with evolving timelines.
Leadership Skills: Ability to mentor junior members of the team (if applicable).
Technical skills: Proficiency in disclosure software and a 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, 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) #LI-MM1 - #LI-Remote
