Description:
The Senior Director is responsible for reviewing materials submitted to the Medical Review Committee (MRC) as well as those submitted to Summit’s Promotional Review Committee (PRC), in accordance with applicable regulations, guidance documents, and internal policies/SOPs.
Role And Responsibilities
- Accountable for evaluating all perspectives (Commercial, Legal/Compliance, Medical) and provide expert regulatory guidance for promotional, disease state education, corporate and other non-promotional materials for relevant products and associated therapeutic areas to cross-functional teams.
- Review materials in Veeva and actively participate in MRC and PRC meetings.
- Review and interpret enforcement actions, keeping current with industry changes relating to advertising and promotion, interpreting new FDA Guidance to Industry documents, and, as applicable, evaluating related internal policies/best practices and processes.
- Contribute to implementing internal MRC/PRC processes to ensure all materials comply with FDA regulations.
- Provide regulatory guidance on overall process enhancements to ensure compliance and process efficiencies.
- Develop and implement regulatory ad promo strategy and managing complex negotiations with internal and external stakeholders.
- Providing guidance on communications with HCPs, patients/consumers, payers, executive management, and other internal and external audiences.
- Facilitate the submission of branded promotional materials to FDA on Form 2253.
- Act as the main point of contact with FDA's Office of Prescription Drug Promotion.
- Advises management and cross-functional team members of the effect of current or proposed relevant laws, regulations, guidelines, and standards, etc.
- Accountable for ensuring that corporate goals are met with respect to assigned projects.
- Acts independently under direction of Vice President of Regulatory Affairs, with the Senior Director Ad Promo expected to represent regulatory with little to no oversight.
- May have direct reports and contributes to the performance management for other RA team members.
- May advance the organization's goals by participating and taking leadership roles in professional associations, industry, and trade groups as appropriate.
- Follow budget allocations.
Experience, Education And Specialized Knowledge And Skills
- Bachelor's degree in scientific discipline and 12+ years of related experience, or the equivalent combination of education and experience.
- An advanced degree (MS, PharmD) is preferred.
- Strong Regulatory Ad Promo knowledge.
- Demonstrated success in the preparation and submission of regulatory documents.
- Strong understanding of the role of Ad Promo and the regulatory requirements for the promotion of prescription drugs.
- Experienced user of the Veeva ecosystem as relates to review and submission of PRC-related items.
- Strong communication and proactive negotiation skills.
- Communicate effectively and articulate complex ideas in an easily understandable way.
- Ability to successfully work in a fast-paced, demanding and collaborative environment.
- Travel up to approximately 5%.