Global Compliance External Engagements Manager

1 month ago


San Francisco, California, United States Daiichi Sankyo, Inc. Full time
Join a Legacy of Innovation

Daiichi Sankyo Group is dedicated to creating and supplying innovative pharmaceutical therapies to improve healthcare standards and address unmet medical needs globally. With a rich legacy of innovation and a robust pipeline of promising new medicines, we strive to become a global leader in oncology and other research areas.

Key Responsibilities
  • Support the Global Compliance & Risk Management organization in reviewing and managing cross-border engagements.
  • Partner with stakeholders to coordinate the submission and review of cross-border engagements.
  • Provide recommendations to modify proposed cross-border engagement submissions.
  • Manage and administer the CBER process, including conducting intake and distribution of requests.
  • Coordinate review/input for all countries implicated in CBER requests.
  • Interact with CBER Committee Reviewers, Local Country-level Reviewers, and Business Requestors to assist with questions related to CBER submissions.
  • Provide status updates to Business Requestors upon request.
  • Conduct close-out of all submissions, ensuring all necessary documentation is obtained and maintained.
Requirements
  • High School Diploma required; Bachelor's Degree in Business Administration, Accounting, or Finance preferred.
  • 5+ years combined experience in a regulated industry, with 3+ years in the pharmaceutical industry.
  • Compliance or Legal experience required; demonstrated understanding of laws and industry guidance governing interactions with healthcare professionals, customers, and patients preferred.
About Daiichi Sankyo, Inc.

We are 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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