Senior Manager, Global Compliance Operations

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:
** The Importance of the Role
** Senior Manager, Global Compliance Operations will report to the Senior Director, Head of Global Compliance Operations and is a great opportunity for a highly motivated individual who is interested in independently managing critical components of the Compliance program in a dynamic and fast paced environment. This role requires strong attention to detail, professionalism, sound judgement, and the ability to work cross functionally with multiple stakeholders.
** The Opportunity to Make a Difference
** This role is responsible for executing tasks and initiatives that span all three pillars of Sarepta’s Global Compliance Program. The successful candidate will contribute to activities supporting Global Healthcare Compliance, Global Data Privacy and Data Management, and Global Sanctions and Trade Controls, as described below.
** Training**:
* Work with manager to develop the annual training plan based on risk assessment
* Support, prepare, and conduct Compliance trainings as needed based on business activity or part of monitoring remediation
* Works with HR to distribute annual eLearning modules and track to completion
* Works with HR to distribute annual policies and track to completion
* Works with Corporate Communications to distribute annual Compliance Minutes Video series
* Responds to internal audit request for training statistics
** Monitoring and Auditing plan**:
* Work with manager on the development of the annual monitoring plan based on the risk assessment
* Live and desktop monitoring
* Live co-travels with field team
* Reviews and analyzes monitoring and auditing results twice a year to test the effectiveness of the Compliance program
* Leverages transparency data to test key internal controls and inform the risk-based monitoring plan
** Risk Assessment**:
* Supports manager in the annual review of company risks based on activities
** Written Standards:
*** Assists in the annual review of all written standards as needed
** Management of Compliance Tools:
*** Tiering & FMV tool including adding more countries and specialties as requested by the business
* Needs Assessment Forms
* Maintenance of Workday Learning resources lifecycle
* Nucleus page
* Maintains all user guides associated with tools
** Other
* ** Leads or participates in other key initiatives as requested.
** More about You
*** Bachelor’s degree required.
* Minimum of 7 plus years of relevant experience in the pharmaceutical, biotech, or medical devices industry with four years of direct compliance responsibilities.
* Strong planning and project management skills.
* Strong computer software skills (Microsoft Office Suite – Word, Excel, PowerPoint, and Visio); ability to manage databases and generate meaningful tables and charts for executive presentations.
* Team player with a high level of interpersonal skills and collaborative working style to effectively work cross-functionally within the company.
* Strong verbal and written communication skills, including ability to communicate with a wide range of individuals…