Associate Director, Global Medical Information and Review

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

The Opportunity to Make a Difference

• Develop and implement global medical information strategies aligned with biotech innovation and patient-centric values.
• Create and maintain scientifically rigorous Standard Response documents based on emerging data and publications.
• Manage external vendors and call center operations to ensure high-quality, timely responses to inquiries from healthcare professionals and patients
• Serve as a key member of MRC & PRC review committees
• Provide timely, medically relevant, scientifically sound, and fair-balanced medical/scientific reviews of materials submitted to medical and promotional reviews
• Responsible for providing oversight of the review of promotional and medical materials for scientific/medical validity across Sarepta's Portfolio.
• Represent medical affairs in global cross-functional team meetings
• Critically review and provide solutions to complex promotional and medical pieces to ensure balance of the messages, medical accuracy, and appropriateness of the content of the materials/activities in accordance to scientific communication and with relevant guidance across Sarepta.
• Proactively cultivate and grow strong relationships with cross-functional leads and other stakeholders to provide medical guidance in the development of scientific materials and resolve issues or concerns in promotional and medical review
• Leverage defined metrics and other tools to improve team performance and ensure adequate resource allocation
• Determine acceptability of data/references used to support promotional claims and provide expert guidance as well as effective negotiation leading to resolution for approval of pieces
• Address any scientific decision support needs from inquiries coming into Sarepta.
• Maintains in-depth understanding of the disease state, product, competitors, marketplace, related medical areas, and regulatory guidelines
• Participate in the creation of, and ensure adherence to, departmental and corporate policies and SOPs and constantly look for places where process improvements would enhance the workflow
• Support commercial planning and launch planning activities including training materials, and medical information to provide scientific and medical support for publications and presentations
• Monitor the medical literature for Sarepta product(s) and relevant competitor data; analyzes the information for accuracy and relevance and appropriately synthesizes the data for inclusion in materials under review.
• Collaborate with commercial operations, marketing, and regulatory operations to support the creation and submission of marketing materials and documentation to regulatory agencies
• Collaborate with Global Medical Communications and Medical Information to align with scientific information, establishing consistent communication
• Assist in driving consistency in medical information and communications, establishing one medical voice internally and externally
• Participate in internal and external meetings (training, educational and others, including medical congresses) to remain current on ever changing regulations, relevant new medical/scientific information and commercial strategy

More about You

• Advanced clinical/scientific degree: PharmD, PhD with 3 to 5 years of experience in medical affairs
• Scientific expertise in rare disease and gene therapy a plus
• Prior knowledge of the medical information and review process
• Excellent interpersonal, written, and verbal communications skills are essential to establish cross functional relationships.
• High degree of accuracy; eye for detail, fastidious
• Ability to effectively manage time while balancing numerous high priority projects with a sense of urgency
• Must be a strong team player and be willing to work in an environment where individual initiative and accountability to the team are required
• Self-motivated with exceptional follow through
• Demonstrates flexibility in response to changing needs and competing demands
• Recognized by former peers, colleagues, managers and direct reports for attributes congruent with Sarepta Values: Drive, Excellence, Resilience, Teamwork, Innovation and Compassion.

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.