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Years of Experience
Date Last Verified
ProfileSenior Lead, US Advertising & Promotion Responsibilities: Provides expert regulatory evaluation of proposed promotional and disease state materials for assigned products. Evaluates materials to ensure compliance with FDA regulations, guidance, corporate standards and policies, and business objectives. In collaboration with Commercial, Medical and Legal colleagues, conducts a detailed review and evaluation of the adequacy of clinical evidence provided to support proposed claims, and assesses consistency of proposed claims with FDA-approved labeling. Serves as the chair of CMLR meetings, and assists Commercial with the planning and prioritization of proposed promotional and disease state materials. Provides expert guidance related to Regulatory strategy during early development projects to ensure promotional goals can be achieved. Manages direct reports to ensure consistent review standards within the EAS system are upheld, and business needs are assessed and addressed. Works collaboratively with colleagues in A&P, Medical, Legal, Commercial, and Compliance to achieve alignment. Provides consistent, well-supported, and clear guidance to key stakeholders. Supports metrics to measure and track the effectiveness and efficiency of the CMLR process, provides recommendations for process improvements to address issues, gains agreement of process improvements from key CMLR-stakeholders, and implements agreed upon process improvements. Collaborates with the International A&P review teams for materials that are intended for global audiences. Maintains a thorough understanding of OPDP and/or APLB requirements, as well as a keen awareness of enforcement trends. Participates in the preparation and review of comments to FDA’s docket regarding Federal Register Notices that may impact the organization’s promotion of commercial products. Serves as primary liaison with OPDP and/or APLB reviewers in the request and negotiation of advisory comments and any other interactions regarding use of promotional claims for assigned products.
Qualification and Experience
Qualifications: Degree in life science or equivalent. Advanced degree (PharmD, PhD, MS, MBA, JD Degree ) preferred. 7 years’ experience in drug, biologic and/or device regulatory affairs or related field, including 3+ years’ experience specific to Regulatory Affairs – Advertising and Promotion. Candidates with experience in related fields may also be considered. Demonstrated knowledge of regulations and regulatory guidances specific to advertising and promotion of pharmaceutical/biologic products. Preferably 2 years in a team leadership role with highly effective people management skills. Expert understanding of FDA regulations and guidances regarding advertising and promotion of prescription drug and biologic products. Significant experience working directly with FDA (OPDP or APLB). Excellent verbal and written communication skills. Demonstrated interpersonal skills with strong strategic and analytical thinking. Ability to work successfully with a cross-functional team. Ability to work independently, take initiative, and complete tasks to deadlines. Must be able to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands. Listens to and carefully considers others’ perspectives, especially to manage and resolve conflict. Drives accountability and responsibility that enables others to act with integrity.