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Daiichi Sankyo, Inc. is the U.S. subsidiary of Daiichi Sankyo, Co., Ltd. The Company currently markets therapies in hypertension, dyslipidemia, diabetes, acute coronary syndrome, thrombotic disorders, stroke risk reduction, opioid-induced constipation, IV iron therapy and metastatic melanoma.
This position is responsible for enabling the on-time delivery of clinical supplies projects across the DSI portfolio. This role is primarily responsible for supporting CSO Project Manager's by developing and updating Study Supply Plans, managing various work streams with key service providers and working with internal departments to progress clinical supply projects.
1. Develops and updates Study Supply Plans in close communication with CSO project Managers.
2. Responsible for the Clinical Label Development process which includes creation of master label text, translations, and label proofs.
3. Manages the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel.
4. Works closely with Quality Assurance to obtain temperature excursion disposition to update impacted inventory in IRT and other related systems.
5. Coordinates authorized destruction of investigational products with approved vendors and obtains required documentation.
6. Vendor Management -supports Person in Plant (PIP) activities when packaging operations for DSI are in-process. Supports investigational product distribution activities at the vendor, including generation of drug orders, review of shipping documentation and obtaining approval to ship
7. Assists in the creation of SOP's and work instructions specific to CSO Supply Planning as requested.
8. Responsible for updating relevant Trial Master Files (TMF) with CSO-related documents
9. Supports the CSO PM in executing additional operational and logistical duties as discussed and agreed to by management
10. Other responsibilities may be part of the role.
- BS/BA required. Degree in pharmacy or related field preferred. MS or PharmD highly beneficial.
- Minimum 7 years of related experience, including Project Management, Clinical Supply Management, and/or Pharmaceutical Development. Oncology experience is preferred. Creation of Supply Planning tools is preferred.
- Good understanding of Pharmaceutical Development, Quality Assurance, and Regulatory (domestic and international).
- Solid knowledge of clinical supply planning, manufacturing, packaging, and labeling.
- Experience in managing third-party contract clinical supply operations.
- Experience managing multiple vendors per project required.
- Import/export knowledge desirable.
- Excellent communication, negotiating, and computer skills.
- Strong team orientation.
Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All 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.