Implementation Lead

Janssen Pharmaceuticals, a member of Johnson & Johnson's Family of Companies is recruiting for an Implementation Lead for Core Risk Minimization Plan (cRMP) activities in the REMS and Risk Management Center of Excellence (RRM CoE), located in Titusville, NJ. At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Scientific Affairs, LLC is part of the Janssen Pharmaceutical Companies. Job Description: The Implementation Lead is responsible for managing the assessment, development, implementation, and documentation of Core Additional Risk Minimization Activities (CARMAs) in the US, and general US risk management strategy under the oversight of the Director, Risk Management Operations in the RRM CoE. Key Responsibilities: Coordinate the implementation strategy for assigned product(s) with core Risk Minimization Plan (cRMP) activities, in collaboration with cross-functional team members In collaboration with Local Safety Officer, Regulatory, Medical Affairs, and Global Medical teams, responsible for crafting and finalizing production of quality documents and submissions to agreed timelines Develop and drive strategy and operations for assigned core Risk Minimization Plan activities in the U.S. Maintain the Global Risk Management Tracker and Dashboard, with periodic review Ensure communication to appropriate team members, global teams, and management, as needed Primary representative for RRM CoE on global risk management teams Represent RRM CoE to assigned external teams and/or working groups Lead operational development, vendor activities, and management for assigned programs Support Risk Management Leads and RRM CoE activities across therapeutic areas Qualifications Education: BA/BS required MA/MBA/MHA preferred Experience and Skills Required: Experienced in program operations, including call center and database development and management, and assessment of effectiveness Experience with regulatory compliance documentation (GDP), and audit/inspection readiness In-depth knowledge and experience with regulatory (FDA) aspects of prescription drug development end-to-end, including experience with various types of US submissions Excellent English oral and written communications skills Ability to travel up to 10%, primarily domestic, which may include overnight travel as determined by customer and business needs. Preferred: Project management proficiency Experience with risk management, specifically Risk Evaluation & Mitigation Strategies (REMS) in the U.S., and Additional Risk Minimisation (ARMs) in EU and ex-U.S. 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 interpersonal, influencing, communication, listening, negotiating and problem-solving/decision-making skills are required. Ability to travel up to 10%, primarily domestic, which may include overnight travel as determined by customer and business needs. 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. Primary Location United States-New Jersey-Titusville-1125 Trenton Harbourton Road Organization Janssen Scientific Affairs, LLC (6120) Job Function Regulatory Affairs Requisition ID 2206056309W