Senior Director, GRA Advertising & Promotion

Position Title: Senior Director, Global Regulatory Affairs Advertising & Promotion

The Senior Director, Global Regulatory Affairs, Advertising & Promotion will be responsible for supporting the Esperion Commercial and Medical Affairs teams to
provide regulatory review and approval of creative and compliant advertising and promotional materials for Esperion products. The Senior Director has responsibility for reviewing and approving the regulatory content of US materials prepared for product advertising, promotional and disease awareness communications. The Senior Director will act as the primary liaison with US FDA on regulatory issues pertaining to promotional materials. The Senior Director will also be responsible for establishing and overseeing the process for review of such materials ex-US through local partners and/or vendors.

Preferred Location: Remote – US

Essential Duties and Responsibilities*

• Provide strategic regulatory guidance to cross functional Marketing, Medical Affairs, and Legal teams in the preparation of compliant advertising and promotional materials and other promotional communications.
• Review and provide regulatory approval of US advertising, promotional and disease awareness materials to satisfy FDA regulations applicable to prescription drug advertising and promotion.
• Serve as primary contact for communication with the US FDA Office of Prescription Drug Promotion (OPDP) for marketed products, including preparation
  and submission of advertising and promotional materials under cover of FDA Form 2253 and any other communications with OPDP related to advertising and
  promotional materials.
• Provide oversight and direction through Regional experts (vendors, partners, 3rd parties) to ensure requirements for ex-US promotional materials are satisfied according to local needs and guidelines.
• Serve as the Regulatory Lead for the cross-functional internal review team (and external consultants/third party vendors) review of US advertising, promotional and disease awareness material utilizing the Veeva electronic document management system.
• Provide guidance in the assessment of Company Core Data Sheets and Target Product Labels for potential impact on regulatory advertising and promotional materials.
• Maintain working knowledge of global regulatory promotional requirements and guidance, including industry practices and specific US FDA requirements and
  relevant FDA enforcement action and outcomes.
• Actively contribute to the development and implementation of regulatory advertising and promotion training programs for cross-functional teams and partners.
• Member of the Global Regulatory Affairs Leadership Team responsible to recommend and drive process improvements as applicable.

• additional duties and responsibilities not listed here may be required
  

Qualifications (Education & Experience)

• BS degree in a relevant discipline with 15 or more years of industry experience in Regulatory Affairs; advanced degree and global industry experience preferred.
• Minimum of 10 years of experience in the review of prescription drug advertising and promotion for compliance with applicable FDA laws, regulations and guidance documents.
• Direct experience communicating and negotiating with OPDP.
• Experience with global standards for advertising and promotion compliance.
• Demonstrated ability to influence others and foster multidisciplinary matrix team collaboration.
• Recent experience in the cardiovascular or lipid drugs therapeutic areas in the US is preferred.
• Strong organizational and communication skills and high level of attention to detail.
• Ability to work in a dynamic, small-company virtual environment and quickly adapt to changes.
• Ability to prioritize and meet aggressive timelines and deliverables.

Notice to Agency and Search Firm Representatives: Esperion Therapeutics is not accepting unsolicited assistance from agencies and/or search firms for any job posted on this or a referring site. Please, no phone calls or emails. All resumes submitted by an agency and/or search firm to any employee at Esperion via email, the internet, or in any other form and/or method without a valid written agreement in place will be deemed the sole property of Esperion. No fees will be paid in the event that a candidate is hired by Esperion as a result of an unsolicited agency and/or search firm referral.