Senior Manager, Disclosures and Transparency

Why Sarepta? Why Now?
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development in gene therapy, RNA and gene editing. 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

Position will manage disclosure and transparency activities for assigned products and programs. This position will perform as a subject matter expert for disclosure and transparency related activities, such as questions about current and approaching regulations, training, and possibly mentoring other disclosure team members.

The Opportunity to Make a Difference

Supports and implements clinical trial disclosure and transparency strategy for assigned products and programs.  Provides clinical trial disclosure and transparency support within the GRT and interfaces with cross functional colleagues as needed to advance clinical trial disclosures and transparency compliance. Applies and further develops knowledge of clinical trial disclosures and transparency requirements and ensures appropriate related procedures are followed.  Leads clinical trial disclosures projects and implements systems and processes related to clinical trials disclosures and transparency. May oversee activities of junior regulatory personnel.

Primary Responsibilities Include:

•  Work with external vendor to maintain and support clinical trial disclosures and transparency reporting compliance

• Engages stakeholders to define and implement internal process improvements as needed

• Liaise with internal and external stakeholders to ensure compliance, accuracy and completeness of deliverables posted to publicly available clinical trial disclosure and transparency sites

• May lead junior team members by overseeing clinical trial disclosure projects and managing workload

• Represents Disclosures on internal teams to support filing activities and lead operational implementation

• Contributes to developing strategies for clinical trial disclosures and transparency while accurately interpreting and reflecting materiality, and Corporate guidelines

• Contributes to global regulatory strategy and execution and participate in Global Regulatory Teams

• Ensure documentation management and record keeping are compliant with expectations and Sarepta SOPs

• Support inspection readiness, preparation for inspection, and inspections

• Maintains/further develops knowledge of relevant evolving regulation and guidance

More about You

• BS or equivalent with 8+ years relevant experience

• Ability to successfully manage projects/timelines, organize/track complex information & prioritize, by communicating with internal and external stakeholders

• Adaptive communication skills (including interpersonal, written, verbal) and able to influence others without authority

• Experience with internal cross functional negotiation

• Proven ability to successfully manage projects and timelines, organize/track complex information, and prioritize accordingly

• Ability to evaluate and recommend process improvement and suggest/implement best practices