Johnson & Johnson Careers
MANAGER PV CONTROLLED DOCUMENT OPS
Requisition ID: 8601181130
Janssen Research & Development, LLC, a member of the J&J Family of Companies, is recruiting for an Manager, Pharmacovigilance (PV) Controlled Documents – Operations to be located in Horsham. PA.
Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
The Manager, Pharmacovigilance (PV) Controlled Documents – Operations is a member of the Training & Document Control Center of Excellence (TDC CoE) group within Compliance Strategy and Analytics (CSA) and is responsible for:
- Development and delivery of Global Medical Organization (GMO), Office of Consumer Medical Safety (OCMS), and cross-sector medical safety procedural documents and other Johnson & Johnson procedural document initiatives
- Represents Janssen GMO/OCMS Controlled Documents in the European Union (EU) and is responsible for front line support of procedural development activities, audits & inspections, among other key point PVCD responsibilities
- Collaborates with medical safety organization(s), Janssen Research & Development (R&D), and Johnson & Johnson (J&J) organizations to ensure procedural document development which promotes regulatory compliance with respect to pharmacovigilance
- Collaborates with Learning Education and Training Management, GMO and OCMS Management, other organizations and sectors to identify and leverage best practices; fostering a culture supporting process improvement initiatives
- Responsible to ensure procedural document processes result in quality deliverables to support the compliance and inspection readiness of the GMO and OCMS organizationsLead the development and delivery of assigned procedural documents by actively partnering with GMO/OCMS functional areas, other partners and Medical Safety Organizations as needed to ensure that desired outcomes and deliverables are met
- Identify and implement programs, metrics, and processes that result in continuous improvement of deliverables for PV Controlled Documents
- Responsible for identifying and leading initiatives to drive standardization and business process efficiencies for TDC CoE processes
- Lead transactional efficiency projects associated with document management and other related Quality System Processes
- Support both front and back room activities during audits and inspections as the PV Controlled Documents Subject Matter Expert (SME)
- Ensure timely and accurate provision of Pharmacovigilance System Master File deliverables
- Perform other related duties as required
- Bachelor degree required preferably in business or health related field; Graduate degree preferred
- Experience in procedural development with a minimum of 6 years business experience preferably in the pharmaceutical industry
- A minimum of 2 years’ experience in the field of document management and/or process design is required
- Management and supervisory experience is desirable
- A track record in operational deliverables, thorough project planning and managing supportive capabilities is required
- A thorough knowledge of the drug development process, pharmacovigilance and good knowledge of worldwide GxP compliance regulations is preferred
- Knowledge of Electronic Document Management System(s), Microsoft Word PowerPoint, Excel, and Visio
- Ability to evaluate operations and procedures against outcomes and identify methods for improving efficiency, accuracy, and compliance
- Knowledge of quality, compliance metric, and process excellence methodologies and analysis
- Ability to maintain excellent multidisciplinary interactions and coordination and the ability to lead/influence others
- Excellent organizational, analytical, strategic, interpersonal, written and oral skills required
- Commitment to providing excellent customer service
- Ability to work independently and successfully manage multiple priorities simultaneously
- Effectively manage departmental base business activities and makes decisions with guidance from management.
- Collaborate and communicate effectively with internal colleagues across the TDC CoE and external business associates globally
- Successfully manage competing priorities
- Effectively assess methodology and delivery impact choices
- Use criteria in making these decisions includes: complexity of processes, impact to patient safety and regulatory compliance level of urgency, effectiveness measures, cost, and technology infrastructure
- Ability to establish successful working relationships with staff at all levels within the organization during the development of procedures.
- Strong personal leadership with demonstrated competency interfacing with senior leaders, strong networking and relationship building skills required.
- Excellent communication and writing skills demonstrated by the ability to develop clear and concise professional correspondence and similar verbal presentation skills.
- While document content decisions are referred to GMO and OCMS Subject Matter Experts and Process Owners, the Manager, PVCD must be able to assist these parties on the appropriateness of content and/or approach to documenting process. The Manager, PVCD must be able to collaborate effectively and professionally with internal colleagues and external parties to foster consensus and resolve issues yet many decisions must be made independently as appropriate to subject matter and responsibilities. The Manager, PVCD must be able to evaluate problems critically, considering compliance and inspection risk, to make Credo based decisions.
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.
United States-Pennsylvania-Horsham-850 Ridgeview Drive
Janssen Research & Development, LLC. (6084)