Compliance Manager

1 month ago

San Francisco, California, United States Daiichi Sankyo, Inc. Full time

Unlock a Legacy of Innovation

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 a rich legacy of innovation and a robust pipeline of promising new medicines, Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.


Key Responsibilities

This position will be part of the Global Compliance & Risk Management organization and will report directly to the Head of Global External Stakeholder Engagement. The successful candidate 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. 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.
  • Coordinating the review/input for all countries that are implicated in the CBER request.
  • Interacting 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.
  • Providing explanations and details of requests to applicable committee members.
  • Providing status updates to the Business Requestor upon their request.
  • Providing review-related input from Local Country-level Reviewers to all CBER Committee members for consideration in their assessment of the submission.
  • Following up on outstanding requests and communicating the final CBER Committee determination to the Business Requestor.
  • Conducting 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.

Requirements

The successful candidate will have:

  • 5+ years combined experience in a regulated industry (e.g., Healthcare, Pharmaceutical, Finance, etc.)
  • 3+ years of experience in Pharmaceutical industry
  • Compliance or Legal experience
  • Demonstrated understanding of laws and/or industry guidance governing interactions with healthcare professionals, customers, and patients

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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