Safety Policy & Process Oversight Lead - 2406184041WDescriptionJohnson & Johnson is recruiting for a Director, Safety Policy & Process Oversight (SPPO) Lead to be remote based in the United States or Canada.At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/The Director SPPO Lead is the key liaison for the Office of Chief Medical Organization (OCMO) with internal and external stakeholders on pharmacovigilance (PV) - specific regulatory topics, leading efforts to identify and assess emerging regulatory and legislative issues that impact global PV operations. He/she also leads cross functional gap assessments for new and revised PV Regulatory Requirements (nrPVRRs), leads commenting activities related to emerging legislation with potential PV implications, ensures global PV Agreements (PVAs) reflect accurate PV requirements, and acts as a PV Policy Expert for the organization.Enable proactive compliance with global PV regulations through:
Leading cross-functional gap assessments related to nrPVRRs with potential global/regional impact, with a focus on more complex nrPVRRs, and providing support to facilitate implementation activities for any confirmed global/regional impacts, as well as following up on implementation activities for updates on corresponding key processes/procedures and systems, to ensure effective implementation as per agreed Implementation Plans.
Providing project management support on an ad hoc basis and for high complexity nrPVRR implementation within OCMO.
Based on global nrPVRR impact assessments, ensuring effective communication of key changes in the PV Regulatory landscape to OCMO and other internal stakeholders at corresponding OCMO, Global Medical Safety (GMS), and cross functional Committees.
Ensuring all requirements and deliverables/outcomes are documented and retrievable for inspection readiness purposes.
Key Responsibilities:
Lead commenting activities related to emerging legislation with potential PV implications to influence the external environment and to anticipate internal implementation activities when these regulations come into force.
Identify opportunities to drive Safety Policy initiatives forward to improve OCMO efficiency and organizational effectiveness.
Provide consolidated interpretation of existing PV Regulations and Policies to give guidance to the business, involving internal SMEs and through benchmarking exercise as needed:
Ensure Global PVAs reflect corresponding PV requirements, including QPPV function and oversight, as appropriate.
Build and maintain a network of internal and external stakeholders to accomplish SPPO strategic goals
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 SPPO strategic goals.
Support key ad hoc GMS projects and deliverables.
Perform related duties as assigned by supervisor.
Maintain compliance with all company policies and procedures.
QualificationsRequired:
A minimum of 15 years of experience in pharmacovigilance or safety-related fields (e.g. Clinical Development, Medical Affairs) is required
Project management experience (or equivalent) is required
Proven capacity to work in a matrix organization is required
Ability of coordinating multi-functional activities in a highly regulated environment resulting in concrete business results is required
Strong critical thinking, analytical skills and problem solving skills are required
Demonstrated networking skills - including ability to interact with internal staff are required
Both verbal and written in a credible and effective way are required
Results oriented with good listening, conflict resolution, negotiation, and interpersonal skills are required
Excellent written and spoken English are required
Proficient knowledge of MS Office products, specifically Word, Excel, PowerPoint, Visio, MS Project, is required
Preferred:
US FDA pharmacovigilance and safety regulatory requirements including for MD/IVD is preferred
Clinical Trials global regulatory requirements is preferred
Global Data Privacy requirements and GDPR is preferred
Experience in Pharmacovigilance agreements is preferred
The anticipated base pay range for this position is $152,000 to $263,350 USD.The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The 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 year. Bonuses are awarded at the Company’s discretion on an individual basis.Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).Employees are eligible for the following time off benefits:Vacation – up to 120 hours per calendar yearSick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar yearHoliday pay, including Floating Holidays – up to 13 days per calendar yearWork, Personal and Family Time - up to 40 hours per calendar yearAdditional information can be found through the link below.For additional general information on Company benefits, please go to:https://www.careers.jnj.com/employee-benefitsJohnson & 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.For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.comPrimary Location NA-US-Pennsylvania-HorshamOther Locations NA-CA-Ontario-Markham, NA-United States, NA-US-Georgia-AthensOrganization Janssen Cilag S.A.S. (7825)Job Function PharmacovigilanceReq ID: 2406184041W