Job details
Salary $106,500 - $160,000 a year
Full job description
Janssen r&d, llc is recruiting for a manager pv compliance, inspection & audit support located in new jersey, pennsylvania, or remote work within the u.sIs also an option.
At the janssen pharmaceutical companies of johnson & johnson, we are working to create a world without diseaseTransforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires usWe bring together the best minds and pursue the most promising scienceWe are janssenWe collaborate with the world for the health of everyone in itLearn more at www.janssen.com and follow us @janssenglobalJanssen research & development, llc is part of the janssen pharmaceutical companies.
The manager pv compliance, inspection & audit support (manager pv compliance, i&a support) is responsible for oversight of the aggregate report tracking process and compliance monitoring of aggregate report submissions to health authorities, in conjunction with the manager, metrics operationsThe individual is responsible to supervise compliance and ensure appropriate documentation is completed when there is a late submission to a health authorityThe individual may be responsible for direct or indirect oversight of vendor resources!
The manager pv compliance, i&a support generates compliance metrics and reports in support of pv compliance oversight and analysis coe key partners, including:
Global medical organization (gmo) and office of consumer medical safety (ocms) senior leadership teams
Office of the qppv (consumer and janssen)
Safety management teams
International pharmacovigilance leadership
Other partners across janssen, consumer, and j&j
Compliance metrics and data produced feed into:
Janssen and consumer quality management reviews
Medical safety council operational compliance committees
Other compliance review venues and for other functional partners
The individual drives the precision and consistency of compliance metrics by leading report validation efforts where vital; and developing, detailing, and coordinating quality control procedures.
Provides input into corrective/preventative actions and effectiveness measures for capas, as appropriateThe individual works across functional areas to develop and implement strategies to drive compliance improvements and leads and/or participates in cross-functional projects centered on process improvement and innovationResponsible for ensuring publication of all standard compliance metrics are completed in a timely, accurate and consistent fashion and will innovate by streamlining processes and driving efficienciesKeys for success in this role include the ability to develop partnerships with global regulatory affairs and local operating company colleagues of all levels and to influence without authority when issues ariseThe individual must resolve sophisticated issues independently and establish when notification to senior management is appropriateAs a subject matter specialist, present compliance metrics at multiple venues and support audits and inspections globally.
As part of compliance, strategy & analytics (csa) pv inspection and audit support, provide preparation, coordination, management, reporting, and follow-up of regulatory authority (ra) inspections and marketing/alliance partner pv audits of relevant functional groups within gmo and ocms.
Manage csa pv inspection and audit support activities including, but not limited to:
Audit and inspection management: coordinate scheduling and logistics, preparation, confirming subject matter expert (sme) lists and interviewees, updating organization charts and overview presentations, managing pre-audit requests for information.
Manage resources for unannounced ra inspections: prepare and maintain master sme lists, contact lists, organization charts, overview presentations, and information related to previous ha inspections.
Manage pv questionnaires, surveys, and queries from marketing/alliance partners and health authorities.
Maintain audit and inspection master schedule.
Prepare and communicate audit/inspection related metrics and reports.
The base pay range for this position is $106,500 to $160,000.
The company maintains highly competitive, performance-based compensation programsUnder current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable planThe 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 yearBonuses are awarded at the company’s discretion on an individual basis.
Employees may be eligible to participate in company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plansAdditional information can be found through the link below.
Eligible for benefits to include medical, dental, vision and time off as well as any others as provided for in the applicable collective bargaining agreement.
For additional general information on company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
Johnson & johnson is an affirmative action and equal opportunity employerAll 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.
Qualifications
Requirements:
Minimum of bachelor’s degree in relevant discipline (business, science, medical, operations, or related degree) with 8-10 years of pharmaceutical industry experience or an advanced academic degree with 6-8 years of pharmaceutical industry experience or an associate’s degree with 10-12 years of pharmaceutical industry experience.
Minimum of 5 years of experience in pv and/or pv compliance monitoring.
Knowledge of global pv laws and regulations.
Ability to function in a global matrix environment.
Excellent communication and writing skills.
Ability to lead global work streams, drive teams to make decisions, achieve deliverables and manage and resolve issues independently.
Ability to evaluate processes and procedures against outcomes to identify methods to improve efficiency, accuracy, and compliance.
Ability to utilize appropriate initiative and autonomy in achieving objectives.
Excellent track record with negotiation and collaboration.
Experience in participation, management, or conduct of audits/inspections.
Proficiency in microsoft excel and sharepoint.
Requires problem solving skills to interpret data & information, analyze, and make recommendations.
Preferences/assets:
Knowledge of gxp requirements and experience with safety processing, clinical study safety reporting, pv, and medical information preferred.
Understanding of and experience with multi-cultural working is preferred.
Project management experience with organizing actions and managing team activities is preferred.
Experience developing and conducting presentations for different levels of management; ability to tailor presentations to the appropriate level of detail preferred.
Primary location
United states-pennsylvania-horsham-800/850 ridgeview drive
Other locations
North america-united states, north america-united states-new jersey
Organization
Janssen research & development, llc (6084)
Job function
Regulatory affairs
Requisition id
2105970448w
