Ed Sleeper Email & Phone Number

Bridgewater, Nj, Us

Cary, North Carolina, Us

Oversight of the Ethics & Compliance program for Veloxis Pharmaceuticals, a fully integrated specialty pharmaceutical company. Veloxis is committed to improving the lives of transplant patients with a focus on the global development and commercialization of medications utilized by transplant patients and by patients with serious related diseases.

Hong Kong, Hk

*HUTCHMED received CRL in June 2022.Oversight of the Ethics & Compliance program for HUTCHMED International, a global biopharmaceutical company developing targeted therapies and immunotherapies for the treatment of cancer and immunological diseases.- Compliance Committee/Board of Directors: Led the HMI Compliance Committee including meeting facilitation, oversight, and execution of action items, and supported communication of program status to the global Compliance Committee of the Board of Directors (China)- Privacy and Data Protection: Oversight and strategic evolution of global privacy and data protection program in support of medical, clinical, and commercial strategies- Compliance Business Advisory: Advisory guidance and oversight across the commercial, medical, clinical, quality, and manufacturing functions in support of HMI’s strategic goals and objectives- Healthcare Compliance (HCC) Risk Assessment: Oversight and management of risk mitigation strategies in partnership with business functions as identified through HCC risk assessment process- Policies and Standard Operating Procedures (SOP): Developed and implemented compliance policies and SOPs in partnership with business functions to support evolution of the ethics and compliance program in lockstep with the culture- Learning and Development: Compliance business owner of Learning Management System (LMS). Responsible for strategic and tactical oversight of compliance learning curricula- Monitoring and Auditing: Conducted monitoring and auditing of key risk areas as identified in the HCC risk assessment- Transparency: Led the transparency and aggregate spend function including covered recipient spend identification, vendor management, and ensured compliance in reporting spend to federal, state, and international entities- Investigations: Led the investigations process in partnership with compliance colleagues, human resources and the appropriate functional leadership as required

Ann Arbor, Michigan, Us

Oversight of the Ethics & Compliance program for Esperion Therapeutics, a commercial-stage pharmaceutical company focused on the development of lipid management therapies.- Compliance Committee/Board of Directors: Led the Esperion Compliance Committee together with Chief Executive Officer and had direct accountability to the Compliance Committee of the Board of Directors- Compliance Business Advisory: Advisory guidance and support across all business functions- Healthcare Compliance Risk Assessment: Oversight and management of risk mitigation strategies in partnership with business functions as identified through the HCC risk assessment process- Policies and Standard Operating Procedures (SOP): Developed and implemented compliance policies and SOPs in partnership with business functions - Learning and Development: Compliance business owner and strategic implementor of “Esperion University” Learning Management System (LMS). Responsible for strategic and tactical oversight of compliance learning curricula- Monitoring and Auditing: Conducted monitoring and auditing of key risk areas as identified in the HCC risk assessment (e.g., ride-alongs, speaker programs, advisory boards, T&E)- Transparency: Led the transparency and aggregate spend function ensuring compliance in reporting spend and samples to both federal and state entities- Investigations: Led the investigations process in partnership with compliance colleagues, human resources and the appropriate functional leadership as required

Summit, New Jersey, Us

*Celgene was acquired by BMS in December 2019.Global compliance responsibilities for Celgene Corporation, a biopharmaceutical company focused on the development of Hematology/Oncology and Inflammation & Immunology therapies. Celgene was acquired by Bristol Myers Squibb (BMS) in 2019.- HCC Learning Strategy and Implementation: Design, development, and implementation of foundational and just-in-time blended learning curricula to support the US and Global healthcare compliance programs. - Global FCPA/ABAC Training: Developed and implemented live scenario based FCPA/ABAC training for Celgene’s Global General Managers- Communications Strategy: Developed and executed communication strategies and tactics to support awareness of US and Global HCC programs- Policies and Standard Operating Procedures (SOP): Development and implementation of HCC policies and SOPs. Led learning efforts to support the Global HCC Policy Handbook portal launch- Business Advisory: Supported the US and Global HCC programs and provided guidance and support around policy and standard operating procedure interpretation for the Commercial and Medical organizations- Fair Market Value: Led operational efforts for the re-design and implementation of the U.S. HCP Fair Market Value tiering program to ensure compliance and alignment across all business franchises- Auditing and Monitoring: Supported Celgene’s HCC auditing and monitoring program through conducting field sales and medical affairs ride-alongs and observing speaker programs- Acquisition Support: Supported the acquisition of Celgene by Bristol-Myers Squibb through partnering with BMS counterparts to knowledge-share and provide policies, SOPs, and training assets

Strategic Healthcare, Corporate and Regulatory Compliance Executive Consultant serving the Pharmaceutical, Biotech and Medical Device industries. Leadership responsibilities for the design, development and implementation of Compliance program solutions for a portfolio of over 100 life sciences organizations. - Leadership alignment and visioning to support compliance and business partnerships- Compliance program design, development and execution (HHS-OIG 7 Elements)- Internal and third party risk assessment and mitigation programs- Training development and implementation / Learning Management System (LMS)- Strategic communications planning and execution- Policy and Standard Operating Procedure (SOP) development and implementation- Auditing, monitoring, and investigations program design and implementation- Federal Sunshine Act and state transparency reporting program consultation and support - Healthcare Professional (HCP) and Key Opinion Leader (KOL) engagement - HCP validation- PDMA/sample compliance management

New York, Ny, Us

Operations and leadership responsibilities for Medscape LLC (WebMD) focused on the development and delivery of Continuing Medical Education/Continuing Education (CME/CE), clinical references and medical news.

Princeton, New Jersey, Us

Operations and leadership responsibilities in developing and delivering life sciences sales training and continuing medical education solutions.

Boston, Massachusetts, Us

Operations and leadership responsibilities in developing and delivering training solutions across multiple industries.

Bridgewater, New Jersey, Us

Operational and leadership responsibilities in developing and delivering technology training solutions to support multiple business functions.

Health Care Compliance Certification

Ms, Organizational Design, Learning And Communications

Bs, Interactive Learning Design

As, Communications And Media Arts