Associate Director Us Medical Ad/promo Regulatory Review

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Associate Director, US Medical Ad/Promo Regulatory Review
The candidate will understand and interpret complex issues about regulatory requirements and promotional strategy. Mentor and develop staff. Supervise, train and provide technical and regulatory guidance to staff. Be the chair of promotional review meetings, and assist Commercial with the planning and prioritization of proposed promotional and disease state materials. Be a 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. Ensure review standards within the electronic approval system (EAS) are upheld, and business needs are assessed and addressed. Support metrics to measure and track the effectiveness and efficiency of the promotional review process and provide recommendations for process improvements to address potential issues. Collaborate with Regulatory Affairs, Medical, Legal, Commercial, and Compliance, execute and approve key Commercial campaigns. Provides expert guidance to help evaluate and mitigate potential risk. Be an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. The role is responsible for thoroughly reviewing and assessing proposed promotional items to evaluate their completeness, accuracy, and compliance with regulatory requirements. Understand broad concepts within Regulatory Affairs and potential implications across the organization. Identify regulatory issues. Offer creative solutions and strategies, including risk mitigation strategies. Provide product development and label development strategies, as needed, to ensure promotional claims can be supported. May provide management of individuals including mentoring, performance management, and staffing decisions. Identify and propose solutions to management for any resource gaps for brand responsibilities. Present to senior management and cross-functional teams regarding shared learnings from FDA advisory comments, recent enforcement actions, and/or guidance documents. Be the primary liaison with OPDP and/or APLB reviewers in the request and negotiation of advisory comments and any other interactions regarding the use of claims for assigned business unit/therapeutic areas. Lead internal Ad/Promo project workstreams (e.g., best practice documents) and active participant at team staff meetings (e.g., present FDA guidance/enforcement letters). Collaborate with the International Regulatory Ad/Promo review teams for materials that are intended for global audiences (e.g., global press releases, new global campaigns). Other duties as assigned. Degree in life science or equivalent. Advanced degree (PharmD, PhD, MS, MBA, JD) preferred. You have a minimum of 5 years' experience in drug, biologic and/or device Regulatory Affairs or related field, including a minimum of 3 years' experience specific to Regulatory Affairs – Advertising and Promotion. Candidates with experience in related fields may also be considered. Knowledge of applicable regulations and regulatory guidance specific to advertising and promotion of pharmaceutical/biologic products for healthcare professionals, payor and consumer audiences. Previous experience in Regulatory Affairs promotion and advertising; experience managing major regulatory filing(s) (e.g., launch advisory comment submission or responses to enforcement letters) or competitor complaints. Provide regulatory guidance to drug development teams, merging scientific principles and FDA law and regulations for development of marketing materials, including representation on global regulatory and labeling teams. Provide leadership related to issues of importance; provide regulatory advice and recommendations involving regulatory issues on topics for which there may not be clear/specific regulatory insights. Understand the phases, processes and techniques used within a clinical development environment, can contribute to clinical study design discussions. Maintain current knowledge of applicable government regulations, particularly those related to advertising and promotion, including key global codes of practice and regulations. Knowledge of historical enforcement actions and can use this when offering recommendations to stakeholders. Excellent oral and written skills, timeline responsibilities, negotiations skills. Work well with others, especially on a cross-functional team, direct reports and senior leadership. Prior leadership of individuals/team preferred. Demonstrated leadership skills. Ability to manage and bring working teams together for common objectives. Model leadership at all levels daily.

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