Hello, I'm Erik A. DeLong.
Details
- Professional CategoryCompliance & Risk Management
- Location
- Years of Relevant Experience20+ years
- Seniority LevelExecutive
- Consulting Rate (Hourly)275
Headline
Experienced Healthcare Compliance Executive for MedTech & Pharma
Experience
Senior Director/Senior Compliance Officer
Relevant/Notable employerStryker, Global Neurovascular DivisionOctober 2021 - CurrentLed the development and implementation of an innovative, business-led, cross-functional, Compliance Champions program. Developed a new and simplified cross-border process on the engagement of consultants. Increased Compliance awareness via new training programs and a weekly, all-hands newsletter. Implemented a Needs Assessment process, Risk Assessment Program, and meal and consultant monitoring program to improve oversight and risk management for the organization. Developed a centralized, global resource for employees regarding Healthcare Professional interactions. Developed strategic plans and led Compliance integration efforts for mergers and acquisitions. Drafted new guidance for commercial personnel related to Stryker clinical studies and for Research & Development projects. Member of the Neurovascular Senior Staff, the Global Leadership Team, the Research Grants Committee, the Grants & Donations Committee, and Chair of the Global Neurovascular Compliance Committee.
Advisory Lead, Ethics & Compliance
Relevant/Notable employerTakeda Vaccines, Inc.June 2019 - May 2021Supported the development and implementation of Takeda’s Ethics & Compliance (“E&C”) policies and procedures across the Global Vaccine Business Unit (“VBU”) including partnering with senior leadership to champion and shape the organizational mindset around Takeda’s Patient-Trust-Reputation-Business model to embed ethical decision-making principles. Supported Business strategy in preparation of the launch of our first global vaccine candidate. Partnered with Takeda’s R&D organization to developed new procedures and tool kits to navigate E&C risk as it pertains to non-Commercial organizations. Drafted new SOPs related to company sponsored research and physician-initiated research. Developed and implemented novel guidance to manage ethical interactions specific to COVID-19, including reviews of patient COVID testing for participants in Takeda’s clinical studies, donations of personal protective equipment, and the change to more web-based interactions between Takeda employees and Patients, Healthcare Professionals, and Government Officials. Coordinated with the Japanese Business Unit to support and align on the Japanese-specific vaccine business. Led a review and update across all of Takeda’s United States based business units to ensure consistency in applying one set of Fair Market Value rates for all U.S. physicians and non-physicians. Participated as a member of the VBU Leadership Team, the Medical, Compliance, and Commercial Forum, and the VBU Culture and Values Network. Core Team member of Takeda’s Global Donations Policy Committee. Prepared E&C-related reports and presentations and other communications for employees and executive management.
Ethics & Compliance Director, Program Development, Implementation, & Monitoring
Relevant/Notable employerTakeda Pharmaceuticals, Growth & Emerging Market Business UnitAugust 2015 - June 2019Supported the development and implementation of Takeda’s Ethics & Compliance (“E&C”) policies and procedures across the Growth & Emerging Markets Region (“GEM”). Responsible for development, implementation, and continuous improvement of a robust monitoring program. Identified potential areas of E&C risk and provided general guidance on how to manage identified risk areas. Supported the development and implementation of an effective E&C training program, including development of an E&C induction training for new employees. Provided advice on appropriate business-level controls necessary to prevent illegal, unethical, or improper conduct. Acted as a subject matter expert on E&C related topics within GEM which included representation on the GEM E&C Committee, the Patient Assistance Program Governance Committee, and the Access to Medicines Governance Committee. Worked with E&C Officers across GEM and globally to implement policies, procedures, and systems to support the various elements of Takeda’s E&C Program, including the roll-out of the new company Code of Conduct. Supported the development and implementation of tools to raise awareness of Compliance-related topics. Proactively identified emerging regulatory issues, developments in industry practices and standards, and risk trends to design appropriate tools, policies and procedures to ensure continuing relevance of the E&C Program. Prepared E&C-related reports, presentations and other communications for employees and executive leadership.
Special Recognition:
Emerging Markets Ethics & Compliance Department “Above & Beyond” Award (2017)
Growth & Emerging Markets, “President’s Award for Leadership Behaviors” (2018)
Compliance Manager, International
Relevant/Notable employerMedtronicMarch 2008 - June 2015Implemented the training and tracking of the company’s global anti-corruption, Business Conduct Standards (BCS), and Code of Conduct programs. Responsible for overseeing compliance matters in multiple Western European countries as well as for six out seven EMEA business units. Strategic Compliance lead, for EMEA, Latin America, and Asia Pacific responsible for overseeing local Compliance Officers and oversight of Medtronic’s Compliance program in these regions. Led ethics investigations related to the United States FCPA as well as compliance monitoring and metrics reviews. Advised and trained employees and senior management. Primary lead on roll-out of a compliance contract lifecycle management tool. Member of the Medtronic Distributor Council responsible for the international distributor monitoring program. Helped design and draft updates to the BCS, implemented new and creative strategies to implement, track, and train on BCS, and created new interdepartmental committees to review compliance requests, violations, and exceptions. Liaised with other Medtronic’s offices on international compliance matters to ensure alignment and coordination with the global program. Primary team member responsible for Compliance related communication. Assisted with litigation, field corrective actions, and mergers and acquisitions. Mentor to 5 local Compliance Specialists with 2 direct reports.
Member, Eucomed Compliance Network Steering Group (2013-2015)
Member, Eucomed Code Revision Committee (2013-2015)
Industry
- Hospitals and Health Care
- Manufacturing
Specific Jurisdictions That I'm Qualified In or Can Cover
United States: California
Language(s)
- English
- French
- Spanish
Education
University of San Francisco
DegreePoliticsAugust 1999 - June 2002
Professional Membership / Certification
INSEAD, Certificate, Healthcare Compliance Leadership Programme, Fontainebleau, France (2010)
Your Skills
FCPA, Anti-Kickback Statute, Compliance
I am interested in
- Career Opportunities
- Providing Services based on my Expertise