Manager, Safety Science & Policy Implementation Specialist
Janssen Pharmaceutical Research & Development, L.L.C., a member of the Johnson & Johnson Family of Companies, is recruiting for a Manager, Safety Science & Policy Implementation Specialist. This position can be based out of Horsham, PA or Raritan, NJ.
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 Manager, Safety Science & Policy Implementation Specialist will be responsible for implementation of process changes within GMO to enable compliance with new or updated pharmacovigilance (PV) regulations and support efforts to identify and assess emerging regulatory and legislative issues that impact global PV operations with internal and external stakeholders. This position will act as a key liaison for GMO with internal and external stakeholders on PV-specific regulatory topics, and will lead efforts to implement regulatory and legislative issues that impact global PV operations. In addition, the Manager will be responsible for other operational activities related to PV Policy, including participating in internal working groups as needed. This position will be responsible for Safety Science & Policy activities within the Global Medical Organization in the following areas:
Enabling proactive compliance with global PV regulations
- Leading implementation of process changes within GMO with new or updated PV regulations
- Driving timely development of key deliverables by planning and facilitating productive working sessions to create deliverables
- Monitoring and tracking progress of project and issues/plans, proactively identifying obstacles, developing contingencies based on risk assessments and influences decision making
- 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
- Ensuring all requirements/objectives and deliverables/outcomes are documented and retrievable for inspection readiness purposes
Developing progress reports on the above implementation plans for senior leaders in Global Medical Safety
- Development of dashboards, storyboards, scorecards to increase visibility and clarity of projects, including key achievements, issues, mitigation strategies, and goal tracking
- Maintain visibility on day-to-day activities with project teams
This position is responsible for providing leadership and support in projects, including content, connections with business units and system tools. The Manager, Safety Science & Policy Implementation Specialist will need to be skilled at assessing data and information, preparing messages, and support of executing strategy. The Manager will need to have knowledge of global PV regulations and PV-related end-to-end processes within GMO and external stakeholders.
Additionally the Manager, Safety Science & Policy Implementation Specialist 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
- Support key ad hoc GMS projects and deliverables
- Build and maintain a network of internal and external stakeholders to accomplish Safety Science & Policy strategic goals
- Other duties as required
- Successful candidates will have a minimum of a Bachelor's Degree preferably in an engineering, science, health policy, health sciences or business field, and a minimum of 5 years of relevant industry experience
- Pharmacovigilance experience or in a safety-related field (e.g. Clinical Development, Medical Affairs) is preferred
- Must have project management experience (or equivalent) and proven capacity to work in a matrix organization
- 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 the ability to interact with internal staff
- Results oriented with good listening, conflict resolution, negotiation, and interpersonal skills
- Proficient knowledge of MS Office products, specifically Word, Excel, PowerPoint, Visio, MS Project, is required.
- Travel 10% of time
North America-United States-New Jersey-Raritan
Janssen Research & Development, LLC. (6084)
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