Project Lead, Program Management, CSP&O Clinical Supply Planning and Operations
- Employer
- Daiichi Sankyo
- Location
- Basking Ridge, NJ
- Start date
- Nov 5, 2024
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- Discipline
- Administration, Clinical, Clinical Research
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
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 more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary
NOTE: This Project Lead Role is an Individual Contributor and sits at the Manager Grade level.
This position is responsible for enabling the on-time delivery of clinical supplies across the DSI portfolio. This role as CSO (Clinical Supply Planning and Operations) Project Lead is primarily responsible for developing and updating Study Supply Plans, managing various work streams with key service providers and working with internal departments to progress clinical supply projects. Every effort has been made to identify the essential functions of this position. However, it in no way states or implies that these are the only duties you will be required to perform, nor is it intended to be such a listing of the skills and abilities required to do the job. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or is an essential function of the position.Responsibilities- Develops and updates Study Supply Plans in close communication with CSO project Management Lead
- Responsible for the Clinical Label Development process which includes creation of master label text, translations, and label proofs.
- Manages the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel.
- Works closely with Quality Assurance to obtain temperature excursion disposition to update impacted inventory in IRT and other related systems.
- Coordinates authorized destruction of investigational products with approved vendors and obtains required documentation.
- 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
- Assists in the creation of SOP’s and work instructions specific to CSO Supply Planning as requested.
- Responsible for updating relevant Trial Master Files (TMF) with CSO-related documents
- Supports the CSO Project Mgmt Lead in executing additional operational and logistical duties as discussed and agreed to by management
- Bachelor's Degree required
- Extensive relevant experience will be considered in lieu of an advanced degree. preferred
- PharmD or related field preferred
- Master's Degree preferred
- 7 or More Years of related experience, including Project Management, Clinical Supply Management, and/or Pharmaceutical Development. preferred
- Oncology experience preferred
- Creation of Supply Planning tools preferred
Company
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 more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
For more information, please visit: www.daiichisankyo.com.
Daiichi Sankyo, Inc., headquartered in Basking Ridge, New Jersey, is a member of the Daiichi Sankyo Group. To learn more about Daiichi Sankyo, Inc., please visit www.dsi.com.
STOCK EXCHANGE: Tokyo Stock Exchange
STOCK SYMBOL: 4568
- Website
- http://www.daiichisankyo.com/
- Phone
- (908) 992-6400
- Location
-
211 Mt. Airy Road
Basking Ridge
New Jersey
07920
United States
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