Associate, Global Compliance External Engagement

Location: Basking Ridge

Employment as a Contingent Worker aligns well with individuals seeking career flexibility and non-traditional work arrangements, while also being motivated to produce exceptional results in prominent roles. Magnit Direct Source is a service provided by Magnit Global that connects top-tier talent directly to an industry-leading company. Daiichi Sankyo, Inc. and Magnit Global, in collaboration, offer flexible contingent assignments across diverse projects creating opportunities for engaging work. 

As a Contingent Worker, you will not be employed Daiichi Sankyo, Inc. You will be employed by our Managed Service Provider, Magnit Global, which oversees the majority of our temporary contract recruitment.

Job Title:

Associate, Global Compliance External Engagement

Job Schedule:

This role is an average of 20 hours per week; the hours can increase depending on coverage for another individual. Candidate can work 100% remote; prefer to be EST based and the schedule will be 10AM-2PM EST - Monday-Friday. The Associate, Global Compliance External Engagement is a fully dedicated global role—not a dual-hatted position—reporting 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. This individual will 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 by providing recommendations to modify proposed cross border engagement submissions, as needed.

Key responsibilities include:

Independent management, organization and administration of the CBER process by conducting intake and distribution of all CBER requests in the Global CBER portal. Ensuring 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. 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.

Conduct independent initial review (“first line 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 applicable 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.

Provide customer support and assistance with customer questions related to the global CBER portal. This role is intended for a pharmaceutical compliance or legal affairs professional with experience managing complex processes, systems, and time-sensitive reviews. The position requires the ability to work independently, make sound decisions, and manage a high volume of high-risk reviews.

Qualifications:

Knowledge of U.S. healthcare rules, particularly as they relate to payments and engagements with HCPs,…