Project Lead, Clinical Supply Planning and Operations

7 days ago


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

Unlock Your Potential with Daiichi Sankyo, Inc.

Daiichi Sankyo, Inc. is a leading pharmaceutical company dedicated to delivering innovative therapies to improve patient outcomes. As a Project Lead, Clinical Supply Planning and Operations, you will play a critical role in enabling the timely delivery of clinical supplies across our portfolio.

Key Responsibilities:

  • Develop and update Study Supply Plans in collaboration with CSO project management lead
  • Lead the Clinical Label Development process, including creation of master label text, translations, and label proofs
  • Manage the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel
  • Work closely with Quality Assurance to obtain temperature excursion disposition and update impacted inventory in IRT and other related systems
  • Coordinate authorized destruction of investigational products with approved vendors and obtain required documentation
  • Support Person in Plant (PIP) activities when packaging operations for DSI are in-process
  • Assist in creating SOPs and work instructions specific to CSO Supply Planning as requested
  • Responsible for updating relevant Trial Master Files (TMF) with CSO-related documents

Requirements:

  • Bachelor's Degree required; extensive relevant experience will be considered in lieu of an advanced degree
  • 7 or more years of related experience, including Project Management, Clinical Supply Management, and/or Pharmaceutical Development
  • Oncology experience preferred
  • Creation of Supply Planning tools preferred

Travel: Ability to travel up to 10% for outsourcing vendor visits.

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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