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Job Function:
Legal & Compliance
Job Sub Function:
Health Care Compliance
Job Category:
People Leader
All Job Posting Locations:
Cambridge, Massachusetts, United States of America, Remote (US)
Job Description:
Johnson & Johnson Innovative Medicine is currently recruiting a HCCO IM R&D North America & BD Integration Support to support all Therapeutic Areas in the integration of newly acquired companies into Innovative Medicine Research & Development. The role provides strategic Health Care Compliance (HCC) leadership to enable compliant, ethical, and sustainable growth.
An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.
Remote work options may be considered on a case-by-case basis and if approved by the company.
This position reports directly to the HCCO Director, Innovative Medicine Research & Development, North America. In addition, this role supports North America Research & Development on cross‑Therapeutic Area and cross‑functional initiatives, including Third‑Party Risk Management and Compliance Monitoring, collaborating with global partners as appropriate. The position may be based in Massachusetts, New Jersey, or Pennsylvania, with travel to Titusville, NJ required at least once per year.
The HCCO IM R&D North America & BD Integration Support is responsible for ensuring that newly acquired companies’ Research & Development organizations are successfully integrated into Johnson & Johnson Innovative Medicine Research & Development in compliance with the requirements of Johnson & Johnson’s Health Care Compliance Program. This role plays a critical leadership position in embedding compliance and corporate integrity principles into integration strategies, operating models, and execution plans.
The position requires extensive collaboration across internal stakeholders, including Therapeutic Areas, Legal, Procurement, Global Development, Global Clinical Operations, Global Transparency Reporting, Third‑Party Risk Management, Supply Chain, Privacy, Business Operations, Global Development Integration Management, and Acquisitions & Divestitures Operations. Through this partnership, the role ensures that health care compliance considerations are proactively addressed as part of integration planning and implementation.
The HCCO IM R&D North America & BD Integration Support will also serve as the North America Research & Development delegate for cross‑functional and/or global Compliance Monitoring initiatives, supporting enterprise risk assessments, gap analyses, and post‑implementation reviews. Responsibilities include close collaboration with Innovative Medicine Research & Development Data Science teams to advance AI‑enabled compliance monitoring capabilities, where practicable.
Responsibilities:
- For Innovative Medicine Research & Development HCC integration of acquired companies:
- Review Research & Development HCC-related documents in target company’s pre-acquisition data room for risk exposure and assess business development team’s findings.
- Immediately after close, based on review of acquired company’s existing compliance program and HCC governance (if any), identify required remediations and strategy to address.
- Deliver principles-based HCC training on the parts of the J&J Compliance Program the company will be required to immediately adopt (prior to full integration). Once WWIDs are issued, ensure new employee HCC training courses are launched to all through Summit.
- Provide business-sensitive, compliance support as needed to empower the acquired company’s employees to make compliant decisions.
- Prior to cut-over to J&J systems, review existing HCC-sensitive contracts and engage with Legal and Procurement to address terminations and amendments required. New HCC-sensitive transactions to be reviewed by role “offline.”
- At cut-over, provide J&J systems and process training to legacy employees as needed and review all migrating HCC-sensitive transactions through the Totality process upon PO reconciliation.
- Ensure Open Payments reporting requirements are met through offline means until cut over, transitioning company and CROs to J&J process thereafter.
- Assess third-party suppliers to determine which are in-scope for TPI-DD. Once WWIDs are assigned, provide Business Sponsor training, and, as assigned HCCO, ensure completion of due diligence for in-scope suppliers.
- Complete HCC FCPA risk profile on acquired company for review with GA&A and Legal. If audit is required, support GA&A as needed and complete any MAPs assigned to R&D HCC which may result.
- Collaborate with A&D Operations, Therapeutic Area, GD, GCO, Procurement and Legal on integration strategic decisions throughout the process.
- As NA R&D delegate on cross-functional and/or global compliance monitoring initiatives:
- Execute monitoring reviews and ensure activities follow established risk frameworks and methodologies.
- Identify patterns, themes, and emerging risks across monitoring outputs.
- Collaborate with Program Management to integrate monitoring insights into dashboards and analytical products.
- Engage with Legal, Internal Audit and business stakeholders as needed on monitoring results and follow-up actions.
- Collaborate with Data Science in the possible development of AI-based tools for monitoring.
- As NA R&D Compliance support for Third Party Risk Management initiatives:
- Serve on project teams contributing to continuous improvement of TPRM methodology, templates and tooling.
- Contribute to the refinement of policies, templates and workflows to enhance efficiency and standardization.
- Support the rollout of process updates, system enhancements or automation initiatives.
- Serve as SME for NA R&D HCC, KPMG and Business Sponsors as needed.
- Other base business responsibilities include, as assigned:
- Review research and development strategies and materials, such as research proposals and Fee-for-Service agreements, to facilitate compliant growth. Ensure materials comply with company policies and procedures, industry standards and applicable state and federal laws.
- Provide guidance, policy interpretations and recommendations relating to business activities.
- With support from the Director, perform risk assessment mitigation process, investigations and required follow-ups in alignment with relevant HCC processes and systems.
- In consultation with the Health Care Compliance Officer Director, HCC leadership, Human Resources, and the Law Department, ensure there is a mechanism in place to appropriately address instances of non-compliance, ensuring consistency in the application of disciplinary action.
- In conjunction with the Health Care Compliance Officer Director and HCC leadership, communicate company healthcare compliance standards and information updates on new laws and guidance to business partners.
Experience and Skills:
Required:
- Bachelor’s Degree required. CCEP or JD preferred.
- A minimum of 10 years of business-related experience required.
- 5 years of experience in the healthcare industry with knowledge of Health Care Compliance programs and policies, Federal health care programs, and FDA requirements required.
- Strong track record of working in a collaborative environment with demonstrated evidence of maintaining relationships and partnerships with peers and business partners.
- Broad business experience and a proven ability to influence business decisions and business partners.
- Demonstrated ability to analyze data and trends and communicate complex information to all levels of the company required.
- Knowledge of R&D for healthcare products and scientific engagement practices with HCPs and GOs.
- Understanding of commercial Sales and Marketing for healthcare products and scientific engagement practices with healthcare customers.
- Experience working in a matrix environment to deliver solutions which drive compliant growth.
- This position is located in either MA, NJ, or PA, with travel to Titusville, NJ at least once a year or more as necessary. May require approximately 10% domestic travel.
- Fluency in English is required.
Preferred:
- Experience working with the governmental regulatory bodies and managing HCC company policies is preferred.
- Experience developing and implementing one or more elements of a compliance program in accordance with an organization's risk profile is preferred.
#HCC
Disclaimer: This job description is not intended and should not be construed to be an exhaustive list of all responsibilities, skills, efforts, or working conditions associated with the job; it is intended to be a reflection of those principal job elements essential for recruitment and selection, for making fair job evaluations, and for establishing performance standards. The percentages of time spent performing job duties are estimates and should not be considered absolute. The incumbent shall perform all other functions and/or be cross trained as shall be determined at the sole discretion of management, who has the right to amend, modify, or terminate this job in part or in whole.
This document is not a contract for employment.
Required Skills:
Preferred Skills:
Audit Management, Compliance Management, Compliance Risk, Consulting, Controls Compliance, Corporate Governance, Critical Thinking, Developing Others, Healthcare Industry, Health Care Regulation, Inclusive Leadership, Leadership, Legal Services, Medical Compliance, Organizing, Program Management, Relationship Building, Team Management
The anticipated base pay range for this position is :
$122,000.00 - $212,750.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
