Clinical Supply Chain Associate, Supply Planning & Logistics in Bernards, NJ at DSI

Date Posted: 9/30/2018

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years and Counting!

With over 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 hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.

Job Summary

This position is responsible for supporting the on-time delivery of clinical supplies projects across the DSI portfolio. This role will be responsible for both supporting CSO Project Manager’s and the Director of Supply Planning and Logistics, by contributing to various work streams with key service providers and supporting special projects/continuous improvement initiatives as required. 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

1. Updates and maintains Study Supply Plans in close communication with CSO project. Managers. Supports the CSO PM in executing operational and logistical duties as discussed and agreed to by management.
2. Supports the clinical product label development process which includes creation of master label text, translations, and label proofs.
3. Manages CMO documentation reviews (i.e, packaging Batch Record) review and approval process with Quality Assurance and other CSO personnel. Coordinates authorized destruction of investigational products with approved vendors and obtains required documentation.
4. Works closely with Quality Assurance to obtain temperature excursion disposition to update impacted inventory in IRT and other related systems.
5. Supports investigational product distribution activities at the vendor, including generation of drug orders, review of shipping documentation and obtaining approval to ship.
6. Oversees clinical site and depot inventories through the course of a study and ensures alignment with supply forecast and study requirements. Reviews IRT specifications, participates in UAT as requested and maintains settings in IRT to align with supply plans.
7. Responsible for updating relevant Trial Master Files (TMF) with CSO-related documents. Supports other department initiatives as requested.

Qualifications

Education
  • BS/BA preferred, however candidates with experience in lieu of a bachelors degree will be considered. Degree in life sciences preferred.
Experience
  • Minimum 2-3 years of related experience, including prior CMO experience, Clinical Supply packaging and labeling, IRT, Clinical Supply Chain Management and operating in a GMP/highly regulated environment. Oncology experience is preferred.
Competencies
  • Good understanding of Pharmaceutical Development and clinical manufacturing organization (CMO) operations.
  • Solid knowledge of manufacturing, packaging, and labeling and associated documentation.
  • Experience interacting with and/or managing third-party contract clinical supply operations/CMO’s.
  • Experience participating in IRT specification reviews, UAT, implementation and maintenance.
  • Experience working in a highly matrixed environment.
  • Import/export knowledge desirable.
  • Excellent communication and computer skills. Ability to multi-task and handle multiple projects at once while balancing timelines and priorities.
  • 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.