Associate Director Us Regulatory Affairs Advertising And Promotion oncology

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Associate Director, US Regulatory Affairs, Advertising and Promotion (Oncology)
The candidate makes decisions and plans for operations (work flow, assignments, staff development) within area of responsibility with minimal direction. Sets strategy and leads cross-functional/multidisciplinary therapeutic teams and multidivisional initiatives. Maintains and evaluates productivity metrics to project current and future business needs Aligns and maintains effective communication channels with key Medical, Marketing, Regulatory, Legal and Public Affairs counterparts. Identifies areas of improvement in process/policy, develops recommendations/plan, and leads initiatives. Assists in the management of the departmental budget, identifies and communicates budgetary needs to Operations and Finance, and identifies and projects current and future expenditures and business needs. Collects and analyzes issues/trends that affect business to identify and act on cross-organization or cross business opportunities. Effective use of knowledge of global marketplace, technology and business levels. Operates independently, with recognition of when to consult departmental senior concerning risks. In absence of Director, is responsible for day-to-day operations. Responsible for departmental initiatives, which have significant impact on both internal and external customers. Encourages innovation and holds employees accountable for delivering on their goals; recognizes, mentors, rewards and recommends promotion for staff members based on their performance, results, and development. Exhibits solid understanding of regulations, and guidance of regulatory authorities, political and legal climate and industry practices related to advertising and promotions to assist in meeting organizational goals. Possesses and leverages broad industry knowledge. Develops and implements complex processes and projects and develops and delivers strategic presentations for senior management. Identifies areas of improvement in process, policy, develops recommendations/plan and leads initiatives. Bachelor’s Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology, nursing, pharmacy) is required. Relevant Master’s or Ph. D, or advanced scientific or law degree is preferred. Should preferably have 8+ years of industry related experience. Should preferably have 8+ years in pharmaceutical experience with an emphasis on RA strategy or US Advertising and Promotion. Experience developing and implementing successful global regulatory strategies is required. Experience in management capacity is preferred. Certification is a plus.

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