Director, Safety Science and Policy Lead

Janssen Pharmaceutical Research & Development, L.L.C., a member of the Johnson & Johnson Family of Companies, is recruiting for a Director, Safety Science & Policy Lead. This position can be based out of Horsham, PA; Raritan, NJ; or High Wycombe, UK.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.

We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

The Director, Safety Science & Policy Lead will be responsible for leading cross-functional gap assessments related to new pharmacovigilance (PV) regulations and drive commenting activities related to emerging legislation with potential PV implications to influence the external environment. This position will act as a key liaison for GMS with internal and external stakeholders on PV-specific regulatory topics, and will lead efforts to identify and assess emerging regulatory and legislative issues that impact global PV operations, and provide project management for high-complexity implementation within GMO. In addition, the Director will be responsible for other operational activities related to PV Policy, leading and participating in internal working groups as needed, managing a PV intelligence network, supporting industry association connections, and may serve as delegate for their manager.

This position will be responsible for Safety Science & Policy activities within the Global Medical Organization including:

  • Enabling proactive compliance with global PV regulations through:
    • Supporting Regional stakeholders (e.g. LSO & LOC), and leading cross-functional teams to review and assess requirements and identify gaps impacting the global and local PV system
    • Issuing non-binding proposals for implementation to appropriate compliance committee(s) for implementation and monitoring
    • Ensuring all requirements and deliverables/outcomes are documented and retrievable for inspection readiness purposes
  • Ensuring effective communication of key changes in the PV Regulatory landscape to GMO and other internal stakeholders
    • Report changes and emerging trends in the PV regulatory environment
    • Identify opportunities to drive Safety Science and Policy initiatives forward to improve GMO efficiency and organizational effectiveness
  • Driving commenting activities related to emerging legislation with potential PV implications to influence external environment through regulatory commenting
  • Leading high-complexity implementation of process changes within GMO with new or updated PV regulations
  • Build and maintain a network of internal and external stakeholders to accomplish Safety Science & Policy strategic goals
    • May represent JNJ in industry association consortium/working groups to advance Safety Science and shape PV legislative environment
    • Lead internal, cross-functional working groups to support above external collaborations
  • Participate in cross-functional teams working on strategic deliverables and cross-sector collaboration within JNJ regarding Safety Science & Policy strategic goals
  • Support key ad hoc GMS projects and deliverables
  • Other duties as required

This position is responsible for providing leadership and support in projects, including content, connections with business units and system tools. The Director, Safety Science & Policy Lead will need to be skilled at assessing data and information, shaping messages, and developing and executing strategy. The Director will need to understand global pharmacovigilance regulations and have knowledge of PV-related end-to-end processes within GMO and external stakeholders. Addtionally, the Director will:
  • Proactively identify issues and problems, can identify and assess risk and the chances of success and offer solutions and recommendations
  • Make complex decisions that resolve regulatory compliance or business issues and demonstrate acute understanding of the impact of decisions taken
  • Interpret the applicability of PV regulatory guidance and processes to propose innovative solutions to compliance challenges and areas of PV Policy
  • Have ability to work across different businesses and cultures on a worldwide basis to ensure global alignment and compliance with key stakeholders
  • Understand stakeholder/customer needs, be able to network building alliances and influence other groups
  • Develop effective and highly communicative relationships across highly complex organizations of multifunctional personnel
  • Exercise excellent judgment in assessing priorities and initiating projects


Qualifications
  • Successful candidates will have a minimum of a Bachelor's Degree (or university equivalent) preferably in an engineering, science, health policy, health sciences, or business field. Advanced Degree (e.g. PharmD, PhD, or MD) is preferred
  • A minimum of 10 years of industry related experience, with at least 3 years of experience in pharmacovigilance or safety-related fields (e.g. Clinical Development, Medical Affairs) is required
  • Must have a minimum of 2 years of project management experience (or equivalent) and proven capacity to work in a matrix organization
  • Strong critical thinking, analytical and problem-solving skills -
  • International experience is a plus
  • Candidates will need demonstrated networking skills, including the ability to interact with internal staff and other company affiliates
  • Ability to facilitate J&J/GMS strategy, positions and policies effectively to promote J&J position in health leadership
  • Results oriented with good listening, conflict resolution, negotiation, and interpersonal skills
  • This position will require up to 10% travel

Primary Location
United States-Pennsylvania-Horsham
Other Locations
Europe/Middle East/Africa-United Kingdom-England-High Wycombe, North America-United States-New Jersey-Raritan
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Pharmacovigilance
Requisition ID
00001CAQ


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