Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Responsibilities will include, but are not limited to, the following:
Manage regulatory aspects of communications with Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP). Serve as communication liaison with OPDP Reviewers. Foster collaborative, efficient, and effective working relations with FDA. Contribute to resolution of enforcement actions. Make procedural commitments to FDA.
Participate in cross functional regulatory development team as a post approval subject matter expert.
Lead and manage a franchise aligned team of 1 to 3 direct reports. Train, coach, and mentor staff at all levels within the department. Prioritizes tasks for direct reports.
Lead and manage regulatory aspects of the copy review / approval process for promotional materials for assigned products, indications, and/or audiences. Ensure compliance of promotional materials with FDA regulations, and ensure submission of promotional materials to OPDP in a timely fashion.
Provide FDA regulatory subject matter expertise, advice and guidance on risk mitigation strategies relevant to US prescription drug advertising and promotion. Provide regulatory expertise, advice, and feedback to commercial teams, promotional review teams, and stakeholder management on marketing concepts and promotional materials.
Foster a business partnership environment between Regulatory and colleagues the review and approval of Celgene advertising and promotional materials. Represent Regulatory Advertising & Promotion in strategic communication and interactions with allied groups.
Manage timelines and resources to achieve stated goals.
Identify areas of improvements to be addressed through policy, SOP, or department practices. Monitor and interpret promotional labeling regulations and guidelines. Develop interdepartmental guidance and procedures. Design and conduct interdepartmental training.
Pro-actively monitor the latest regulations, guidance, and actions from the FDA and competitors that may influence the landscape. Provide colleagues in GRA and allied functions with cutting edge guidance on requirements and changes.
Lead preparation for and provide onsite leadership for Regulatory Agency Inspections with questions regarding Celgene Advertising and Promotional Materials.
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Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.