Associate Director, Global Medical Information and Review

Sarepta Therapeutics Inc.•Cambridge, MA

35d•Hybrid

About The Position

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. The responsible individual will play a critical role in supporting, leading and development of the department of Medical Information & Review within the Medical Affairs function reporting to the Head of Global Medical Information & Review. This individual will work closely and effectively with key members of internal departments including Marketing, Legal/Compliance, Regulatory, PV, Medical Affairs and Clinical Development to assure that all materials, both promotional and medical, meet the rigorous standards of scientific accuracy, objectivity, and fair balance. This person will also serve on cross functional teams, representing medical affairs.

Requirements

Advanced clinical/scientific degree: PharmD, PhD with 3 to 5 years of experience in medical affairs
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.

Nice To Haves

Scientific expertise in rare disease and gene therapy a plus

Responsibilities

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