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Risk Management Lead (Titusville, NJ) - Johnson & Johnson Innovative Medicine

Johnson and Johnson
Hopewell, NJ Full Time
POSTED ON 2/19/2025
AVAILABLE BEFORE 5/14/2025

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. At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.

Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at https : / / www.jnj.com / . For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day.

Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world.

Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges. We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve.

Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued, and our people can reach their potential. At Johnson & Johnson, we all belong. 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 team
  • 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 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.

    Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan.

    The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar / performance year.

    Bonuses are awarded at the Company's discretion on an individual basis.

  • Employees and / or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs : medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
  • Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
  • Employees are eligible for the following time off benefits :
  • Vacation - up to 120 hours per calendar year
  • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
  • Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below.
  • https : / / www.careers.jnj.com / employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States.

    Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. 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.

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