Associate Director, Regulatory Information Management Systems

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.
 

#LI-Hybrid

#LI-ES1

This position is hybrid, you will be expected to work on site at one of Sarepta’s facilities in the United States and/or attend Company-sponsored in-person events from time to time.

The targeted salary range for this position is $160,800 - $201,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.

Candidates must be authorized to work in the U.S.

Sarepta Therapeutics offers a competitive compensation and benefit package.

Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.