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Job Description - Risk Management Lead (Titusville, NJ) – Johnson & Johnson Innovative Medicine (2506233919W) Description Johnson & Johnson Innovative Medicine is recruiting for the role of Risk Management Lead (RML) in the REMS and Risk Management Center of Excellence (RRM CoE), located in Titusville, NJ. The Risk Management Lead is responsible for handling the development, implementation, and assessment of one or more Risk Evaluation and Mitigation Strategies (REMS) and general US risk management strategy under the oversight of the Director, Risk Management Strategy. Key Responsibilities: Coordinate the risk management strategy for assigned product(s) in collaboration with cross-functional teams. Develop and drive strategy and operations for assigned U.S. risk management programs and REMS. Ensure communication to appropriate team members, global teams, and management as needed. Primary representative for RRM CoE on cross-functional REMS teams. In collaboration with Global Regulatory Affairs, responsible for crafting and finalizing production of quality REMS submissions to agreed timelines. Represent RRM CoE to assigned external teams and/or working groups. Communicate US risk management advice and guidance on evolving REMS requirements and regulations with business partners. Lead vendor activities, operational development, and management of assigned programs. Support RML-REMS and REMS Core Teams across therapeutic areas. Qualifications Required: A minimum of a BS degree is required. Experienced in risk management (REMS) program operations, including call center and database development and management, and assessment of effectiveness. In-depth knowledge and experience with regulatory (FDA) aspects of prescription drug development end-to-end, including experience with various types of US submissions. Preferred: MA/MBA/MHA or other advanced degree preferred. Proficient in regulatory aspects at various stages of development, from entry-into-man to post approval activities. Experience working with and presenting to the FDA, including coordinating and leading meetings for scientific, regulatory, and/or safety advice. Ability to influence within function, cross-functionally, and globally. Excellent communication, interpersonal, negotiation, and problem-solving skills. Other: Excellent oral and written communications skills - English is required. Ability to travel domestically up to 25%, which may include overnight travel as determined by customer and business needs. The anticipated base pay range for this position is 137,000 to 235,750. The Company maintains highly competitive, performance-based compensation programs. This position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. #J-18808-Ljbffr Johnson & Johnson

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