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Associate Director, Safety Science & Policy Scientist
Requisition ID: 00001CAR
Janssen Pharmaceutical Research & Development, L.L.C., a member of the Johnson & Johnson Family of Companies, is recruiting for an Associate Director, Safety Science & Policy Scientist. 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 Associate Director, Safety Science & Policy Scientist will be responsible for pharmacovigilance (PV) regulation intelligence, track global PV regulations, and PV-related external influencing activities, and support efforts to identify and assess emerging regulatory and legislative issues that impact global PV operations with internal and external stakeholders. In addition, the Associate Director will be responsible for other operational activities related to PV Policy, including leading and participating in internal working groups as needed.
Responsible for Safety Science & Policy activities within the Global Medical Organization including:
- Monitoring global regulatory environment for new or updates to PV regulations
- Supporting Regional stakeholders (e.g. LSO) and conducting initial assessments identifying gaps impacting the global and local PV system
- Supporting the coordination of cross-functional teams to review and assess requirements on PV regulations and identify gaps impacting the global and local PV system
- Supporting the issues of 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
Tracking and communication activities:
- Tracking PV regulations globally to review trends and improve GMS efficiency and organizational effectiveness
- Collect and report changes and emerging trends in the PV regulatory environment
- Tracking and providing metrics on PV-related external influencing activities including regulatory commenting on draft PV regulations
- Developing progress reports on PV Policy activities for senior leaders in Global Medical Safety
- 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 Associate Director, Safety Science & Policy Scientist will need to be skilled at assessing data and information, preparing messages, and support execution of strategy. The Associate Director will need to understand global pharmacovigilance regulations and have knowledge of PV-related end-to-end processes within GMO and external stakeholders.
Additionally the Associate Director, Safety Science & Policy Scientist will –
- Proactively identify issues and problems, can identify and assess risk and the chances of success and offer solutions and recommendations
- Make decisions that resolve regulatory compliance or business issues and demonstrate acute understanding of the impact of decisions taken
- 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
- 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. A Master’s Degree in appropriate discipline or MBA is preferred
- Minimum of 8 years of related industry experience, and a minimum of 2 years of experience in pharmacovigilance or safety-related fields (e.g. Clinical Development, Medical Affairs) are required
- Project management experience (or equivalent) and proven capacity to work in a matrix organization is preferred
- Demonstrates ability of coordinating multi-functional activities in a highly regulated environment resulting in concrete business results
- Strong critical thinking, analytical and problem-solving skills
- Demonstrated networking skills – including ability to interact with internal staff
- Results oriented with good listening, conflict resolution, negotiation, and interpersonal skills
- Languages: Excellent written and spoken English required.
- Travel 10% of time
Europe/Middle East/Africa-United Kingdom-England-High Wycombe, North America-United States-New Jersey-Raritan
Janssen Research & Development, LLC. (6084)