Associate Director, Global Medical Information and Review at Sarepta Therapeutics

Cambridge, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

27 Feb, 26

Salary

195000.0

Posted On

29 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Medical Affairs, Scientific Accuracy, Interpersonal Skills, Written Communication, Verbal Communication, Time Management, Team Player, Self-Motivated, Flexibility, Critical Thinking, Gene Therapy, Rare Disease, Promotional Review, Regulatory Guidelines, Process Improvement, Medical Information

Industry

Biotechnology Research

Description

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 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. 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. #LI-Hybrid #LI-CM1 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 $156,000 - $195,000 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. Sarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. 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. Our deep pipeline is driven by our multi-platform technologies in siRNA, RNA and gene therapy. For more information, please visit www.sarepta.com or follow us on Twitter, LinkedIn, Instagram and Facebook.

Responsibilities

The Associate Director will support and lead the Medical Information & Review department, ensuring that all materials meet scientific accuracy and compliance standards. They will also manage external vendors and provide oversight for the review of promotional and medical materials across Sarepta’s portfolio.