Senior Director, Ad Promo

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 Senior Director of Regulatory Advertising & Promotion serves as the strategic regulatory leader for U.S. promotional activities across the product lifecycleincluding development-stage assets launch materials and fully marketed products (including Accelerated Approved products). This role provides expert guidance to ensure that all promotional diseasestate and externalfacing communications comply with FDA regulations and industry standards while supporting business objectives. The Senior Director partners closely with key stakeholders and senior leadership to shape compliant and competitive promotional strategies from prelaunch planning through postmarket execution. This role also facilitates risk identification and mitigation strategies as well as oversees regulatory interactions with OPDP/APLB. The Senior Director develops and maintains a Performance Culture through building and sustaining high performing teams responsible for the timely review approval and submission of promotional content.

The Opportunity to Make a Difference

Principle Duties and Responsibilities

• Oversees and provides strategic regulatory advice and for the development and approval of compliant advertising and promotional materials across the product lifecycle- includingdevelopment-stage assets launch materials and fully marketed products (including Accelerated Approved products) disease state education field training external communications and for non-promotional pre-approval communications
• Oversees the development of launch materials/new claim by collaborating with Marketing Medical and Legal
• Responsive to business goals offering creative and compliant solutions while ensuring Company regulatory integrity and consistency in communications and activities
• Develops and maintains working relationships with OPDP/APLB staff as necessary
• Represents RA on multidisciplinary teams to integrate company goals into regulatory objectives & activities
• Global Regulatory Teams key contributor to establish and implement regulatory strategy
• Maintains a deep knowledge of FDA enforcement trends and relevant evolving regulation and guidance and advises appropriate departments within the company of these requirements
• Identifies and spearheads training in FDA regulations for pharmaceutical advertising and promotion as well as FDA enforcement trends to Sarepta employees and/or its representatives
• Advises on the development and implementation of the strategic approach to building and maintaining an efficient and compliant MLR process
• Creates a strong regulatory promotional compliance infrastructure which includes overseeing the development of SOPs that support inspection-readiness
• Builds and maintains a strong working relationship with internal MLR stakeholders including Marketing Marketing Operations Patient Affairs Legal Medical/Medical Affairs and Scientific/Medical Communications
• Champions to stakeholders at all levels within the organization a collaborative solution-oriented culture aligned with company goals

Impact and Scope

• Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company
• Erroneous decisions will result in critical delay(s) in schedules/unit operations & may jeopardize overall business activities
• Oversees execution of tasks involved in mentoring and goal/strategy setting
• Provides strategic guidance on projects that have critical impact on functional area and organization
• Typically develops organizational policies and authorizes their implementation.
• Champions alignment with organizational business objectives both within GRA and cross-functionally
• Serve as a trusted advisor to senior leadership helping balance business needs with regulatory risk.
• Prior involvement with digital and social media promotional strategies.
• Expected to present and contribute to presentations at governance committees including Research and development Committee the Executive Committee and the Communications Committee

More about You

Skills and Competencies

• Extensive experience in Regulatory Promotional review
• Strong leader with demonstrated management of contract or permanent staff; experience managing remote and local employees and/or regulatory consultancies
• Excellent interpersonal collaboration written verbal and visual communication skills with ability to influence cross-functionally
• Exceptional ability to interpret and apply regulatory requirements to realworld promotional tactics.
• Strong analytical skills problem solving and strategic thinking; must be able to remain detail-oriented while analyzing the big picture
• Ability to exercise sound judgment in fastmoving highvisibility situations.

• Must be goal-oriented results-focused and flexible; proven ability to successfully manage projects and timelines organize/track complex information prioritize accordingly and the ability to quickly adjust to shifting priorities and demanding timelines when necessary
• Collaborates effectively with cross-functional colleagues at all levels
• Ability to evaluate and recommend process improvement; ability to suggest and implement best practices
• Solid sense of accountability and sound judgement; highest ethical standards and focus on quality and attention to detail
• Experience working with and effectively communicating to stakeholders/partners at all levels globally across the organization
• Proficiency with Microsoft Office Applications; Word Excel Outlook and regulatory systems

Education and Experience

• BS or equivalent with 15 years of related experience
• Prior regulatory affairs experience in major markets (FDA or EU) is expected

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

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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 $222400 - $278000 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.