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 2023 we launched our fourth therapy and the first ever gene therapy to treat Duchenne.

Were 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 : 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 Sareptas 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

What Now

Were always looking for solution-oriented critical thinkers.

So if youre 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 Sareptas 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 $156000 - $195000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sareptas 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.

Required Experience :

Director

Key Skills

EMR Systems,Post Residency Experience,Occupational Health Experience,Clinical Research,Managed Care,Primary Care Experience,Medical Management,Utilization Management,Clinical Development,Clinical Trials,Leadership Experience,Medicare

Employment Type : Full-Time

Experience : years

Vacancy : 1

Yearly Salary Salary : 156000 - 195000