Associate Director, Compliance Process Review

Associate Director, Compliance Process Review - W Description Johnson & Johnson is hiring for an Associate Director, Compliance Process Review in Spring House, PA or Titusville, NJ. About Johnson & Johnson 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 For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the worlds most pressing healthcare challenges. We know that the success of our business and our ability to deliver meaningful solutions depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential. At Johnson & Johnson, we all belong. Johnson & Johnsons Innovative Health Engagement and Advocacy (IHE&A) organization has been created to drive substantial impact to participant health and wellbeing by reinventing the clinical trial experience. The Innovative Health Engagement & Advocacy organization connects teams across development to novel capabilities and solutions, igniting the potential of innovation to drive broader access to innovative medicines, and enrich the healthcare experience for all! Position Summary: IHEA organization is seeking to hire a solution oriented, innovative and engaging member in their Patient Engagement Strategy team who will be responsible for leading all aspects of and ensuring the successful implementation of the Compliance Review Committee (CRC) process. This role works closely with the Patient & Site Engagement team, Advocacy, Clinical Research Equity, Study teams, and other partners involved in patient or healthcare professional recruitment. The primary focus of this role is to understand and support patient recruitment and retention strategies while ensuring all materials, tactics, and content created for recruitment and retention purposes are compliant and undergo the vital compliance review process. Principal Responsibilities: Lead a multi-disciplinary team through the Compliance Review Committee (CRC) Process. Identify opportunities to optimize the process, implement the improvements in collaboration with J&J Compliance partners and stakeholders. Proactively bring valuable insights and recommendations to the J&J Compliance partners (RAP, Privacy, Legal, HCC) from external partners, e.g. IRBs, advocacy partners, etc Create a culture of learning organization by conducting regular trainings of the CRC process and SOPs to the CRC customer teams advising on Dos and Donts Serve as the Business Process Owner for Compliance Processes, to build and maintain relationships with CRC Stakeholders and Compliance Partners. Provide specialized compliance and strategic advice on approved tactics, applicable guardrails, evaluating new concepts, resolving issues/requests from CRC partners. Strategically provide direction and clearly articulate any potential compliance risks, along with rationales and anticipated likely outcomes; facilitate productive conversations to develop viable alternatives and solutions to help accomplish the identified goals through active teamwork and an agile way of working. Facilitate and lead activities surrounding strategic input into policies, procedures, and training related to compliance. Proactively identify challenges and facts that are subject to applicable laws, regulations, guidelines, and company policies and help develop alternatives or mitigation plans. Partner with Advanced Analytics organization to pilot Generative AI capabilities for identification of patterns and generate alternate recommendations on content. Accountable for the review and approval of all recruitment and retention tactics. Serve as a subject matter authority for R&D Clinical trials on Digital Guidance Pillar and Digital Governance Board Principal Relationships: Contacts inside the company may include: Regulatory Advertising and Promotion, Privacy, Health Care Compliance, Global Legal Organization, PDO, GCSO, and IT Contacts outside the company may include Patient Recruitment and Retention Vendors Qualifications Bachelor's degree is required, preferably in a scientific or health-related field Minimum of 5 years relevant experience in clinical trial execution with a pharmaceutical company and/or CRO Strong background in patient recruitment/retention Demonstrated ability to identify and implement improvement in a process Continuous Improvement Approach Ability to work independently with strong influence skills Possess sharp analytical skills and the ability to solve complex problems by identifying root cause and creating multi-faceted solutions Excellent communication and negotiation skills, with a demonstrated ability to influence stakeholders across matrix organizations Ability to thrive in ambiguous and complex environments Excellent written and verbal communication and presentation skills Preferred:- Experience with Generative AI is highly preferred Lean/Six Sigma Experience is highly preferred 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. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit The anticipated base pay range for this position is $146,000 to $251,850. 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 corporations performance over a calendar/performance year. Bonuses are awarded at the Companys discretion on an individual basis. Please use the following language: 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 Companys consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Companys long-term incentive program. Employees are eligible for the following time off benefits: Vacation up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington up to 56 hours per calendar year Holiday pay, including Floating Holidays up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market." Primary Location NA-US-Pennsylvania-Spring House Other Locations NA-US-New Jersey-Titusville Organization Janssen Research & Development, LLC (6084) Job Function Multi-Family R&D Operations Req ID: W

Created: 2024-11-05