Sarepta
Associate Director, Regulatory Information Management Systems
Company
Role
Associate Director, Regulatory Information Management Systems
Location
United States of America
Job type
Full-time
Found on Mokaru
4 days ago
Salary
Job description
Why Sarepta? Why Now?
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
We’re looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
What Sarepta Offers
At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:
Physical and Emotional Wellness
Financial Wellness
Support for Caregivers
For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us
The Importance of the Role
Sarepta is searching for an experienced professional to lead and support critical activities related to Sarepta’s Regulatory Information Management System (RIMS), which is used to develop regulatory submissions for dispatch to health authorities globally. The Associate Director, RIM will have responsibility for leading the operational, administrative, and strategic support of assigned business systems; as well as contributing to projects and initiatives that optimize the use of information technology to achieve departmental, divisional, and enterprise business objectives.The Opportunity to Make a Difference
Lead and manage the administrative and operational support of assigned systems
Partner with Regulatory Affairs and cross-functional stakeholders to gather and translate business requirements into system solutions
Monitor, assess, and improve the administrative and operational support processes – including, but not limited, to user access, user experience, procedural documents, user training, and issue resolution
Lead improvements to existing business processes and system configurations
Ensure documentation management and record keeping are compliant with regulatory expectations and Sarepta SOPs
Establish and maintain system governance, including change control, release management, and documentation
Define and monitor key metrics of risk and performance for assigned systems
Support preparation for inspection readiness by ensuring regulatory correspondence and submissions are complete, traceable, and readily retrievable
Provide focused and customized RIMS training to users; assist with the development of training materials
Determine and track KPIs related to system utilization, stability, and data quality against defined targets for assigned systems
Master RIMS reports and dashboards to support functions with their reporting and metrics needs
Integrate AI and emerging technologies to create efficiencies
Lead RIMS validation activities, including identification of users’ needs as well as authoring, review, and execution of test scripts to support thrice yearly and ad hoc system enhancements
Operate under low supervision
More about You
BA or BS degree or equivalent
10 or more years of relevant experience with demonstrated expertise in document management, regulatory submissions, Regulatory Information Management, archiving, and metrics generation and analysis
Demonstrated hands-on experience with Veeva Vault RIM, including regulatory document management, metadata usage, and records lifecycle management
Expert proficiency with the Veeva RIM suite of applications, including Registrations, Submissions, and Submissions Archive
Strong understanding of regulatory business processes as they relate to RIMS
Ability to evaluate and recommend process improvements and suggest/implement best practices
Experience with change controls related to validated computer systems and understanding of Computer Software Assurance principles
Fully developed knowledge of relevant evolving regulations and guidance around global operations initiatives impacting Regulatory Operations and the systems they support including eCTD, document management, and RIM
Experience attending industry conferences to keep abreast of best practices and industry trends
Proficiency with Microsoft Office applications, including Word, Excel, Outlook, and Adobe
Adaptive communication skills (including interpersonal, written, and verbal) and able to influence others without authority
Ability to successfully manage projects/timelines, organize/track complex information and prioritize, and communicate effectively with internal and external stakeholders
Attention to detail and ability to solve problems
What Now?
We’re always looking for solution-oriented, critical thinkers.
So, if you’re comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.
