• Engagement Compliance, Manager

    J&J Family of Companies (Spring House, PA)


    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

    Job Function:

    R&D Operations

    Job Sub** **Function:

    Clinical Trial Support

    Job Category:

    Professional

    All Job Posting Locations:

    Spring House, Pennsylvania, United States of America

    Job Description:

    About Innovative Medicine

     

    Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

     

    Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

     

    Learn more at https://www.jnj.com/innovative-medicine

     

    We are searching for the best talent for** **Engagement Compliance, Manager to be in Spring House, PA.

     

    **Purpose:** IHEA organization is seeking to hire a solution oriented, innovative and engaging member in their Patient Engagement Strategy team who will be responsible for supporting the compliance review process including facilitating the successful implementation of the Compliance Review Committee (CRC). This role works reports to the Associate Director, Engagement Compliance and works closely with the Patient & Site Engagement team, Advocacy, Clinical Research Equity, Study teams, and PSE teams involved in patient or healthcare professional recruitment/retention and site support for our portfolio of studies. Additionally, this role works closely with compliance partners in RAP, HCC, Legal and Privacy. The primary focus of this role is to understand and support teams in the process of ensuring all materials, tactics, and content created for patient recruitment and retention purposes/site facing support tactics and materials are compliant and undergo the vital compliance review process.

    A pre-selected candidate has been identified.

    You will be responsible for:

    + Manage and ensure all submissions meet compliance requirements and follow the appropriate workflow processes. Assign materials to appropriate reviewers in alignment with critical timelines. Track submission progress and outcomes and escalate issues to prevent process delays.

    + Provide guidance and advice on process as it relates to the review and approval of tactics, applicable guardrails, new concepts, as well as resolving issues/requests from CRC partners.

    + Provide daily compliance support to RAP, Legal, HCC, Privacy, PSE, and study teams, troubleshoot workflow issues based on user feedback and business needs and act as a key contact for users navigating the compliance review process

    + Contribute to enhancing process functionality and implement optimizations in collaboration with end users and J&J Compliance partners (RAP, Privacy, Legal, HCC) and stakeholders.

    + Facilitate weekly CRC meetings, including all new concepts and other topic identification and agenda preparation, scheduling with cross-functional teams (Legal, RAP, HCC, Privacy, PSE and Study Teams), documentation of decisions and action items via annotated PDFs.

    + Actively support activities surrounding strategic and process related input into policies, procedures, and training related to compliance

    + Maintain CRC SP site including forms, trackers, tools for end users and partners including ongoing communications related to updates, improvements or other needs. Support process for providing appropriate KPIs, Metrics and Dashboard for analysis, trending and resource needs.

    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 / Requirements:

    + Bachelor's degree is required, preferably in a scientific or health-related field

    + Minimum of 3 years relevant experience in clinical trial related activities at a trial institution or with a pharmaceutical company and/or CRO and experience in compliance operations, workflow systems and platforms

    + General knowledge of clinical trial operations, ICH GCP and regulatory environment

    + Demonstrated ability to identify and implement process efficiencies/improvement

    + Ability to manage high volumes of data and workflows with precision and efficiency

    + Demonstrated proficiency with Microsoft, Excel, Veeva Vault VTMF, Domino and system platforms

    + Excellent communication and negotiation skills, with a demonstrated ability to communicate with and train stakeholders across matrix organizations

    + Excellent written and verbal communication and presentation skills

     

    Preferred:-

     

    Experience with Generative AI 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.

     

    Reporting to: Associate Director, Engagement Compliance, PES

     

    Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

     

    Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ([email protected]) or contact AskGS to be directed to your accommodation resource.