Associate Director, Compliance Process Review

Company: Disability Solutions
Location: Spring House
Posted on: October 23, 2024

Job Description:

Johnson & Johnson is hiring for an Associate Director, Compliance Process Review in Spring House, PA or Titusville, NJ.About Johnson & JohnsonAt 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/.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 world's 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 & Johnson's 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:

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• 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 Do's and Don't's
• 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\rPrincipal Relationships:
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  • 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\r\r

Keywords: Disability Solutions, Baltimore , Associate Director, Compliance Process Review, Executive , Spring House, Maryland