Manager, Global Compliance External Engagements
4 weeks ago
Join a Legacy of Innovation 110 Years and Counting
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Summary
This position will be part of the Global Compliance & Risk Management organization and will report directly to the Head of Global External Stakeholder Engagement. This position will be responsible for supporting the global Cross Border Engagement Review (CBER) process and will also serve as the initial reviewer for all US-led CBER submissions. Partner with other members of the CBER process, including CBER Committee Reviewers, local/country-level approvers, and CBER Steering Committee members to coordinate the submission and review of Cross Border Engagements. Additionally, this role will consult with US-based employees prior to their submitting requests to CBER (which are the majority of CBER requests) by providing recommendations to modify proposed cross border engagement submissions, as needed. This position requires working and making decisions independently, managing a high volume of high-risk, time-sensitive reviews, and a strong working knowledge of US healthcare rules, particularly as they apply to payments to and engagements with HCPs, customers, and patients.
Responsibilities
- CBER Program and Process Responsibilities
Independent management, organization and administration of the CBER process by conducting intake and distribution of all CBER requests in the Global CBER portal. Ensure that all CBER submissions are complete, qualify for CBER, and contain all required documentation prior to distribution to CBER Reviewers. Responsible for coordinating the review/input for all countries that are implicated in the CBER request. In instances where this no Local Country-level Reviewer, follow up with the CBER Committee member to whom the country aligns, who will be responsible for obtaining country specific guidance. Interact directly and frequently with CBER Committee Reviewers, Local Country-level Reviewers, and Business Requestors to assist with questions related to the review of CBER submissions. Independently provide explanations and details of requests to applicable committee members. Provide status updates to the Business Requestor upon their request. Provide review-related input from Local Country-level Reviewers to all CBER Committee members for consideration in their assessment of the submission. Follow up on outstanding requests and communicate the final CBER Committee determination to the Business Requestor. Conduct close-out of all submissions including ensuring that all necessary documentation has been obtained, is included in the electronic file and is maintained in accordance with record retention requirements.
- Review of US CBER Requests
Conduct independent initial review (“first pass review”) of all planned CBER requests originating from DSI Business Requestors to determine if they (1) require CBER review and (2) if proposed engagements comply with healthcare laws/regulations, internal policy and procedure requirements. Make decisions/provide feedback to the CBER requestors regarding actions to be taken on each request. Responsible for flagging issues pertaining to anti-kickback, false claim, and transparency reporting laws/regulations for additional DSI Compliance or Legal Affairs review.
- CBER Meetings
When live CBER Committee or CBER Steering Committee meetings are necessary (for example, where the submission addresses a new or novel engagement in order to work through and/or to mitigate any issues/concerns), arrange meetings as required. Prepare all agendas, schedule, and conduct all meetings and report all meeting results.
- Communications and Documentation
Manage, administer and maintain the CBER portal webpage. This includes providing customer support and assisting with customer questions and updates to the CBER system, developing new forms, posting CBER-related resources, and creating training material that can assist in training stakeholders on the CBER process, policies and procedures. May occasionally assist with copying, scanning, distributing, data entry and maintenance of CBER requests as needed. Gather information for reports, metrics, generate reports and archive requests and related data (in accordance with company Records Management requirements, policies and practices).
- Training
Responsible for developing resource and training material to support implementation and continued learning of the CBER process. Provide CBER process-related training, including live, in-person training to internal associates.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)
- High School Diploma required
- Bachelor's Degree Preferably in Business Administration, Accounting or Finance. Requirement may be met by 6 years of relevant pharmaceutical industry experience specific to Engagements with HCPs and Customers preferred
Experience Qualifications
- 5+ years combined experience in a regulated industry (e.g., Healthcare, Pharmaceutical, Finance, etc.) required
- 3+ years of experience in Pharmaceutical industry required
- Compliance or Legal experience required
- Demonstrated understanding of laws and/or industry guidance governing interactions with healthcare professionals, customers, and patients preferred
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
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