What are the responsibilities and job description for the Associate Director, Promotional Review position at Sarepta Therapeutics?
Why Sarepta? Why Now?
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development in gene therapy, RNA and gene editing. 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
Key position in Regulatory Affairs working within a cross functional team responsible for the review and approval of compliant communications to help educate healthcare professionals and consumers about Sarepta's marketed products and related diseases. Serves as subject matter expert on FDA regulations and guidance documents pertaining to prescription drug advertising and promotion. Provides regulatory leadership to the Promotional Review Committee (PRC) and participates in the review of scientific material within the Medical Review Committee (MRC) as requested. Communicates and maintains up to date knowledge on laws and FDA regulations and provides interpretation pertaining to FDA guidance related to prescription drug advertising and promotion. Builds and maintains positive rapport and working relationships with FDA as well as internal colleagues in Regulatory Affairs, Medical Affairs, Legal, Commercial, and other cross-functional stakeholders.The Opportunity to Make a Difference
- Provides sound regulatory advice for the development of compliant materials and activities related to new product launches, existing marketed products, development products, disease state education, field training, and other external communications.
- Collaborates with Medical and Legal colleagues in the review of branded materials to ensure promotional claims align with current approved product labeling. Provides Regulatory leadership in review of new claims, campaigns and implementing product label changes into new and existing materials.
- Responsive to business goals offering creative and compliant solutions to challenging promotional concepts while ensuring high standards of regulatory integrity and consistency in communications/activities.
- Provides strategic input regarding the preparation and submission of advertising and promotional materials to the Office of Prescription Drug Promotion (OPDP)/Advertising, Promotional Labeling Branch (APLB) that are compliant with applicable laws and regulations. Works collaboratively with Regulatory Operations and Commercial Operations teams to ensure accurate, compliant, and timely regulatory submissions. As the responsible official Regulatory contact, develops working relationships with OPDP/APLB staff as necessary with specific focus on managing pre-submission requirements for accelerated approval products and requests for advisory feedback. Interprets FDA feedback and communicates timely with stakeholders.
- Monitors for changes in the regulatory environment and identifies enforcement trends. Provides training on FDA regulations and current environment to PRC teams as well as other stakeholders.
- Identifies and alerts GRA leadership to the need for potential risk mitigation discussions.
- Participates in developing, modifying, and executing company policies that affect immediate operations and may also have company-wide effect. Provides input to enhance policies, standard operating procedures, best practices, and work instructions that pertain to material review and approval management.
- May oversee activities of junior regulatory personnel and manage contractual and budgetary responsibilities with best business practices.
More about You
- BS or Equivalent with 10 years of related experience
- Prior experience in the promotional review of rare disease and accelerated approval products preferred.
- Experience in representing Regulatory on PRC teams and proficient in advertising and promotional review (e.g., review of branded and non-branded materials)
- Prior experience consulting with OPDP and/or APLB review staff
- Experience working with and leading cross-functional teams.
- Excellent collaboration, verbal, and written communication skills
- Strong interpersonal skills and the ability to influence others without authority.
- Excellent organizational and negotiation skills
- Ability to evaluate and recommend process improvement and suggest/implement best practices.
- The ability to multitask, prioritize, and work under pressure in adhering to deadlines.
- Proven ability to successfully manage projects and timelines, organize/track complex information, and prioritize accordingly.
- Solid sense of accountability and sound judgement; highest ethical standards and focus on quality and details.
- Experience collaborating with stakeholders/partners at all levels, globally, across the organization.
- Proficiency with Microsoft Office Applications; Word, Excel, Outlook, Veeva and other regulatory systems.
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.
