Maintain a continued awareness and understanding of FDA and international Health Authority regulations, guidance documents, and enforcement actions with regards to advertising and promotion of pharmaceutical products. Support as needed for product labeling activities QUALIFICATIONS Education/ Experience: Bachelors or advanced degree in a scientific discipline, with a minimum of 10 years of biopharmaceutical industry experience, with a minimum of 6-8 years of regulatory experience in the biopharmaceutical industry; minimum of 3 years' experience in the regulatory review of advertising/promotional materials for prescription drug and/or biologic products. Excellent planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines. Requires ability to work both independently and in a team environment, to set priorities to meet timelines, to motivate and influence others. Process oriented to achieve the business objective.
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