Director, Regulatory Affairs, Promotion and Advertising Review (OPAR)

Merck2 Locationsonsite$173k–$273kView the original posting at Merck ↗

Job Description Job Description: The Individual Contributor Director is responsible for the review and approval of US promotional materials and serving as the promotional regulatory expert with legal, medical and commercial colleagues to ensure that promotional practices are consistent with regulatory guidelines, our Company's policies, and support business objectives. Functions at an advanced and independent level. Serve as the liaison and manage correspondence with FDA’s promotional review divisions OPDP/APLB, including complex regulatory questions and submissions for advisory comment. Propose creative, effective, and compliant regulatory strategies and solutions to challenging promotional concepts that meet business objectives and minimize regulatory risk. Proactively partners with the review team, compliance, and commercial colleagues to ensure a cohesive and integrated regulatory strategy from early development through approval and marketing. Lead the development of assigned products’ promotional regulatory strategy, including the rationale for Global Target Product Information (GTPI). Provide solutions to complex regulatory scenarios and content. Identify and provide solutions during labeling and global regulatory team meetings to ensure support for anticipated promotional messages and claims (aligned with marketing strategy) in clinical trial design and product labeling as it relates to the use of study results in U.S. promotion. Maintain an expert understanding of FDA regulations governing advertising and promotion. Proactively provides solutions to complex regulatory and commercial needs in a compliant manner, consistent with US FDA regulations, PhRMA Code and Principles, and company policy and procedures. Is seen as a leader and is sought out by peers. Creates capacity to provide support to team members. Proactively seeks opportunities to take on more complex projects and provide promotional regulatory training and coaching to team members. Mentors’ new hires. Lead the development of departmental strategic initiatives to drive effective, compliant promotional regulatory review. Qualifications, Skills & Experience Education Minimum Requirement: B.A. or B.S. degree with an emphasis in science, health care or related fields. Preferred: Master’s, PhD or PharmD degree with an emphasis in science, health care or related fields. Qualifications Minimum of ten years of pharmaceutical/biologics industry or related experience with an emphasis in regulatory or scientific disciplines, including a minimum of five years of direct experience as the primary reviewer of advertising and promotional materials. Demonstrated in-depth understanding of FDA regulations and our Company's policies and procedures related to promotion development and implementation, as well as promotion review processes. Demonstrated strong diplomacy, interpersonal, and negotiation skills. Recognized as a consensus builder with strong strategic and analytical thinking capabilities. Proven track record of effective collaboration with external stakeholders, including FDA branches (OPDP, APLB), alliance relationships with peer companies, and external consortia and trade organizations such as DIA. In-depth understanding of the clinical development process, regulatory policy, labeling development, and FDA approval processes. Demonstrated ability to identify solutions to complex promotional regulatory issues. Demonstrated superior verbal and written communication skills. Required Skills: Advertising Compliance, Communication, Cross-Functional Teamwork, Detail-Oriented, FDA Regulations, Negotiation, Pharmaceutical Advertising, PhRMA Code, Policy Implementation, Problem Solving, Regulatory Affairs, Regulatory Risk, Regulatory Strategies, Strategic Thinking, Team Collaboration Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in

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