Amber Rawcliffe
Lancashire
Summary
Senior healthcare compliance professional with 10 years of experience across EMEA Innovative Medicine and MedTech sectors, recognized as a subject-matter expert in third-party intermediary due diligence (TPIDD), compliance, and risk-based approvals within centralized compliance operating models.
Consistently recognised with "Exceptional" performance ratings over multiple years, reflecting sustained excellence in delivering results and exceeding expectations.
Overview
10
10
years of professional experience
6
6
years of post-secondary education
Work history
HCC Senior Specialist
Johnson & Johnson Innovative Medicine ESO
2024.11 - 2026.01
- Key contributor to the design, build, and embedding of the centralised TPIDD hub, supporting the transition to a consistent, scalable, and risk-based due diligence operating model across EMEA.
- Executed complex and high-risk TPIDD approvals, applying clear, defensible risk rationale and escalation recommendations in line with HCC requirements.
- Provided HCC approval oversight and advisory support across five Therapeutic Areas, including review and sign-off of business plans, identification of compliance risks, and ongoing guidance to commercial teams.
- Recognised as a trusted HCC point of contact for Therapeutic Area stakeholders, responding to compliance queries and providing pragmatic, risk-based advice to support compliant business execution.
- Led a Q4 GACS assessment for TPIDD, coordinating inputs, assessing control effectiveness and identifying key improvement actions to strengthen the framework and operating model going into this year.
- Recognised as a subject matter expert, supporting consistent interpretation of compliance requirements and contributing to quality, consistency, and continuous improvement across centralised compliance activities.
HCC Specialist
Johnson & Johnson Innovative Medicine ESO & Global
2022.07 - 2024.10
- Split role 50% EMEA Strategy & Operations (ESO), 50% Global Commercial Strategy Organisation (GCSO)
- Led a major overhaul of the TPIDD process in GCSO after a critical MAP, shifting to a centralized approach - achieving 0% overdue cases while ensuring strict compliance and proactive red flag handling.
- Conducted HCC review and approval across 2 Therapeutic Areas
- Directed communication strategies, delivering effective campaigns on VivaEngage to keep stakeholders informed and compliant.
- Managed onboarding and training program to ensure smooth risk mitigation, stronger compliance, and alignment with global strategies.
- Served as Risk Assessment DRI, submitting QRR metrics, updating RAMI and reporting to HCC Compliance committees on time.
Senior Business Compliance Associate
Johnson & Johnson MedTech EMEA
2021.01 - 2022.07
- Led a team of 3 direct reports, driving 100% compliance and high performance through coaching, training, and virtual collaboration.
- Managed the design and launch of a centralized SharePoint training hub, improving accessibility and compliance training across the business.
- Played a key role in the migration from HCC Life 2.8 to V3.0, overseeing system testing, training, and troubleshooting to ensure smooth implementation and compliance.
- Led transparency and KPI reporting, providing accurate, timely data to senior management and ensuring compliance with privacy-driven regulations.
Business Compliance Associate
Johnson & Johnson MedTech EMEA
2017.02 - 2020.12
- Facilitated compliance processes to ensure adherence to statutory and regulatory healthcare policies, in alignment with MedTech Code and the company’s Credo.
- Successfully rolled out an external evaluation project across multiple sites in Europe, demonstrating excellent project management and cross-functional collaboration.
- Negotiated and drafted detailed contracts for HCPs and GOs in various sectors, ensuring compliance with legal and regulatory requirements.
- Identified and proactively escalated compliance risks, offering innovative solutions and advice to stakeholders to mitigate issues.
Business Ops & Compliance Associate
Johnson & Johnson MedTech UK/Ireland
2020.01 - 2020.09
- Implemented a digital signature system to streamline contract approval, boosting efficiency and ensuring compliance.
- Led rebranding and restructuring of the team SharePoint site.
- Created training materials, including work instructions and video tutorials, to standardise compliance processes and enhance understanding of HCC Life across the business.
- Managed UK/IE charitable contributions, ensuring compliance, handling contract logistics, and processing purchase orders for over 150 Trusts on time.
Business Quality Administrator
Johnson & Johnson MedTech OneMD
2016.05 - 2017.02
- Played a key role in managing product complaint reporting and coordinating Field Action notices for 11 franchises, ensuring timely compliance with Health Authorities.
- Successfully reduced late reporting of adverse events to 0%, resolving a critical audit issue and enhancing compliance performance.
- Trained 80% of the salesforce on new complaint reporting procedures, ensuring widespread adoption and compliance.
Education
HCC Implementation Leadership Programme - Part 1
INSEAD
France 2024.07 - 2024.07
Society of Corporate Compliance & Ethics Essentials Workshop
SCCE
Online 2023.02 - 2023.02
Diploma of Higher Education - Professional Development, Leadership & Organisational Change | Postgraduate Certificate
Harper Adams University College
2012.02 - 2014.02
Bachelor of Science - Psychology
University of Leeds
Leeds 2008.09 - 2012.06
Timeline
HCC Senior Specialist
Johnson & Johnson Innovative Medicine ESO
2024.11 - 2026.01
HCC Implementation Leadership Programme - Part 1
INSEAD
2024.07 - 2024.07
Society of Corporate Compliance & Ethics Essentials Workshop
SCCE
2023.02 - 2023.02
HCC Specialist
Johnson & Johnson Innovative Medicine ESO & Global
2022.07 - 2024.10
Senior Business Compliance Associate
Johnson & Johnson MedTech EMEA
2021.01 - 2022.07
Business Ops & Compliance Associate
Johnson & Johnson MedTech UK/Ireland
2020.01 - 2020.09
Business Compliance Associate
Johnson & Johnson MedTech EMEA
2017.02 - 2020.12
Business Quality Administrator
Johnson & Johnson MedTech OneMD
2016.05 - 2017.02
Diploma of Higher Education - Professional Development, Leadership & Organisational Change | Postgraduate Certificate
Harper Adams University College
2012.02 - 2014.02
Bachelor of Science - Psychology
University of Leeds
2008.09 - 2012.06