Manager, Regulatory Policy Research (1 of 2)

Johnson & Johnson Innovative MedicineWashington, DC
1dHybrid

About The Position

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 About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine Johnson & Johnson Innovative Medicine R&D is recruiting for a Manager, Regulatory Policy Research. This position is a hybrid role and can be located in Raritan, NJ or Washington, D.C. The Manager, Regulatory Policy Research will be part of a 4-person Policy Research and Operations (PRO) group that provides operational, research, and technical support to the Global Regulatory Policy and Intelligence (GRPI) team, and broader Global Regulatory Affairs (GRA) organization. This role will be responsible for managing internal tools and processes, coordinating regulatory resources, supporting commenting programs and assisting with policy strategy execution. This individual will be highly organized and comfortable working across scientific, policy, and administrative domains. Serve as a key connector across the team, ensuring projects, meetings, and deliverables run smoothly.

Requirements

  • A minimum of a Bachelor’s degree in a scientific or technical discipline is required.
  • A minimum of 4 years of experience in the pharmaceutical industry or Contract Research Organization (CRO) is required.
  • A minimum of 2 years of experience in Regulatory Affairs Policy support is required.
  • Familiarity with regulatory intelligence platforms and collaboration tools (e.g., Citeline, Cortellis, SharePoint, Power BI, Teams) is required.
  • Strong computer skills, with the ability to work with programs such as Smartsheet and SharePoint, required.
  • Must have excellent oral and written communication skills.
  • Must have strong negotiation and stakeholder management skills.
  • The ability to manage multiple priorities and work cross-functionally in a global, matrixed environment
  • This position will require minimal travel.

Nice To Haves

  • An advanced degree (Master’s, PharmD, Ph.D.) in a scientific or technical discipline is preferred.
  • Experience working at a major health authority (e.g., FDA) is preferred.
  • Solid understanding of the global regulatory environment, including the U.S., European Union and Asia Pacific, is preferred.
  • Understanding of global regulatory systems is preferred.
  • Knowledge of healthcare policy landscapes is preferred.
  • Experience with digital health and/or artificial intelligence (AI) is preferred.

Responsibilities

  • Scientific Research Support: Conduct scientific and policy research to support GRPI and GRA initiatives, positions, and ad-hoc queries. Deliver comprehensive research and policy resources to GRPI leaders and policy leads.
  • Regulatory Intelligence: Provide regulatory intelligence support to GRPI and GRA, ensuring that the team provides timely and relevant insights. Coordinate and manage training programs related to regulatory intelligence.
  • Research: Conduct research for various outputs including publications, presentations, and policy positions. Ensure research activities align with organizational goals and regulatory requirements.
  • Policy Tools and Processes: Create and implement tools, under leadership of PRO Director, to support policy priorities, strategic plans, and other policy documents. Identify opportunities to use technologies to simplify policy team processes and approaches. Develop, successfully implement, and drive adoption of technology tools to support policy priority-setting and strategic planning.
  • Commenting Program Coordination: Support GRPI-led commenting efforts on health authority documents and global regulatory initiatives. Manage cross-functional participation in the commenting tools, ensuring proper document retention, archived guidances, and user support.
  • Website and Tools Management: Support development and maintenance of the GRPI website and related tools, ensuring they are up-to-date and effectively support GRPI activities. Manage meeting logistics and communication activities.
  • Policy Team Support: Support the policy team’s coverage of trade association policy activities and other external policy groups as needed, ensuring alignment with company objectives. Track and report on trade association policy activities and external policy group engagements. Manage meeting logistics, communications, and follow-ups for internal and external policy engagements. Partner with policy leads to plan and execute regulatory policy workshops on high-priority policy topics.
  • Contracts & Consultants: Provide support to PRO Director related to consultant purchase orders and invoices, ensuring timely payment and accurate recordkeeping. Support annual contract renewals and scopes of work for GRPI consultants.

Benefits

  • 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 Work, Personal and Family Time - up to 40 hours per calendar year
  • Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
  • This position is eligible to participate in the Company’s long-term incentive program.
  • Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave – 80 hours in a 52-week rolling period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year
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