Senior Manager, Clinical Trial Transparency & Disclosure - MODERNA : Job Details

The Role:The Senior Manager of Clinical Trial Transparency & Disclosure is a high-impact role, reporting directly to the Director of CTTD. The chosen individual will not just be responsible for Plain language Summaries but will excel in delivering other transparency and disclosure deliverables, from the meticulous planning and coordination stage to the delivery of the final products. As Senior Manager of CTTD, you will be more than a team member you will be a crucial pivot in our clinical development team, deeply understanding and appreciating how your work significantly influences the broader objectives of our clinical development programs.Here's What You'll Do:Functional Knowledge: Apply an in-depth conceptual and practical knowledge of concepts, theories, and principles of transparency & disclosure within all clinical development programs.Document Planning: Develop and manage comprehensive, strategic document plans for clinical and regulatory submissions.Project Management: Oversee the timely and efficient progress of disclosure 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 all written documents comply with regulatory, industry, and corporate guidelines and standards.Data Interpretation: Interpret and present clinical data and other complex information.Quality Control: Implement and oversee quality control processes for authoring and reviewing clinical and regulatory documents.Disclosure Updates: Regularly update and revise study details on global registries as necessary to reflect current information and meet regulatory requirements.Problem Solving: Solve complex problems; take a new perspective on existing solutions; exercise judgment based on the analysis of multiple sources of information.Impact: Solve complex problems; take a new perspective on existing solutions; exercise judgment based on the analysis of multiple sources of information.Develop and Implement Departmental Strategies: Provide input into goals and objectives for the CTTD team that align with the company's overall strategy.Line Management: Responsible for management of direct reports (if applicable)Here's What You'll Bring to the Table:Education and Years of Experience: Advanced degree (preferred) with approximately 4 years of relevant experience OR bachelor's degree with approximately 9 years of relevant experience.Industry Experience: Proven experience in plain language summary of registration and results (Ct.gov; CTIS) and authoring disclosure documents for submission to global authorities.Interpersonal Skills: Excellent interpersonal skills, with the ability to guide others either internally with other areas or externally with vendors and cross-functional team members to adopt a different point of view. Ability to explain difficult or sensitive information; work to build consensusLeadership Skills: Ability to manage the daily activities of multiple supervised individuals; adapt functional plans and priorities to meet short-term service and/or operational objectives. Ability to lead functional projects or programs; Mentor and collaborate with colleagues with less experienceBusiness Expertise: Knowledge of best practices and how CTTD integrates with others within organization sub-function; is aware of the competition and the factors that differentiate them in the market.Communication Skills: Exceptional written and verbal communication skills, with the ability to clearly convey complex scientific information.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: Proficiency in Microsoft Office and familiarity with Disclosure software and tools.Here's What We'll Bring to the Table:Daily on-site catered lunches [Cambridge] On-site subsidized cafeteria [Norwood]Company-provided iPhoneFree parking, monthly subway pass or a subsidized commuter rail passFree annual corporate membership to BluebikesHighly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSPFlexible Spending Accounts for medical expenses and dependent care expenses16 weeks of 100% paid parental leave for all new parents16 weeks 100% paid family caregiver leave20 weeks 100% paid medical leaveEligible for “Moderna Month” (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)Adoption assistance and discounts to local childcare centers, as well as access to care.com401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediatelyA suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disabilityVoluntary legal assistance plan15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)At Moderna, we believe that when you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between.Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needsA holistic approach to well-being, with access to fitness, mindfulness, and mental health supportLifestyle Spending Accounts to personalize your well-being journeyFamily planning and adoption benefitsGenerous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdownSavings and investment opportunitiesLocation-specific perks and extrasAbout ModernaSince 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.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.Our Working ModelAs 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.Moderna is a smoke-free, alcohol-free, and drug-free work environment.Equal OpportunitiesModerna 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 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 an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.AccommodationsWe're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can 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 [email protected] .Export Control NoticeThis position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.#LI-KH1 -#J-18808-Ljbffr