This individual will provide timely, evidence-based, fair-balanced medical information to external customers and internal stakeholders, while remaining current with industry best practices, environmental influences, and overall medical standards of care.
Their skills in communications excellence and scientific analysis establish a foundation for a high quality Global Medical Information department at Sarepta.
The Associate Director, Medical Information will report to the Senior Director of Global Medical Information and Review.
He / she / they will be a key contributor to the Medical Affairs product team(s) and follow compliance and other prevailing industry guidelines to ensure proper dissemination of medical information for Sarepta’s approved products and pipeline.
He / she / they will work closely and effectively with key members of internal departments including Clinical, Legal, Regulatory Affairs, and Commercial, and serve as a resource for Medical Information and therapy area expertise.
Primary Responsibilities Include :
- Advance Medical Information business processes, through policies, operational oversight, strategic perspectives, and monitoring of industry trends
- Create and maintain product knowledge database, including but not limited to, Standard Response Letters and Frequently Asked Questions summaries that approved for distribution by an internal Medical Review Committee
- Respond directly to escalated customer inquiries as needed, including developing Custom Response Letters, while strengthening a network of cross-functional subject matter experts
- Ensure cross-functional reconciliation activities are in place and fully executed
- Perform routine and literature monitoring / searching, support strategic projects, and contribute to literature monitoring and journal clubs
- Engage daily with vendor contact center staff, including direct case management, customer interaction, and agent coaching
- Manage / oversee other vendor activities, including but not limited to, department contractor, translation and outsourced medical writing
- Maintain subject matter expert knowledge of products and contribute to periodic insights generation, launch preparation, and critical Medical Affairs deliverables
- Limited travel : professional development or support of Medical Affairs at medical conferences
Desired Education and Skills :
- 8-10 years pharmaceutical industry experience in Medical Information or Medical Communications successful experience in associated functions such as Pharmacovigilance will also be considered
- Scientific / clinical degree preferred : BSPharm / PharmD, BSN / MSN (health care related PhD considered)
- Experience in neurology and / or rare disease preferred, but not required
- Understanding of US and global regulations pertaining to Medical Information, as well as medical / promotional review process
- Adept in developing medical response materials, including expert use of multiple scientific literature search engines
- Able to work collaboratively on a multi-disciplinary team, willing to work in an environment where individual initiative and accountability to the team are expected
- Strong analytical, critical thinking, and problem-solving skills, applied to project, people, and vendor management
- Strong interpersonal, written and verbal communication
- Attention to detail with a high degree of accuracy
- Enthusiasm for innovating Medical Information solutions
LI-Hybrid
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.