Associate Director, Risk Management
4 weeks ago
The Role:
Join Moderna Therapeutics enthusiastic and collaborative team and make a significant impact on the overall success of our novel messenger RNA approach to drug development. By joining our Clinical Safety and Risk Management Team, the Associate Director, Risk Management is responsible for providing Risk Management Plan (RMP) support for Modernas investigational and marketed products.
Heres What Youll Do:
Support the global risk management activities for investigational and marketed products throughout the product life cycle including providing support to local and regional teams
Assist in the development of the core product risk management strategy in collaboration with cross functional stakeholders (e.g., Pharmacovigilance, Epidemiology, Clinical, Regulatory, and Pre-Clinical) including risk characterization, impacts of risks, risk assessment, risk minimization and measurement of the effectiveness of risk minimization activities
Help oversee the implementation of risk minimization activities in collaboration with relevant key stakeholders
Contribute to the overall process for Risk Management Plans (e.g., SOPs, WI, templates, tracking) including training
Assist in setting up risk management planning based on RMP submission requirements communicated by internal and external stakeholders
Support inspections, audits and quality improvement initiatives related to RMPs
Interact with regulators or external experts as well as business partners as applicable
Support RMP training both internally and externally
Heres What Youll Bring to the Table:
Degree in Pharmacy, PhD, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background
Minimum 6 yearsof pharmacovigilance experience, including experience in supporting RMPs for both investigational and marketed products.
Knowledge in international RMP regulatory guidelines (e.g: GVP module V, CIOMS IX)
Technical skills in Document Management Systems and Microsoft Office
Skilled at working effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
Excellent time management skills
Independently motivated, detail oriented and strong problem-solving ability
Excellent organizational skills and demonstrated ability to multi-task in a fast-paced environment with changing priorities
Excellent written and verbal communication skills with the ability to interact across multiple functions
Knowledge in global pharmacovigilance regulations
This role can be based in Princeton, NJ, Cambridge, MA or Bethesda, MD and requires a hybrid work arrangement with an onsite commitment of 70%.
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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