Manager, Clinical Supply Planning and Logistics in Bernards, NJ at Apex Life Sciences

Date Posted: 10/13/2018

Job Snapshot

Job Description


 Manager, Clinical Supply Planning and Logistics

Duties:

Develops and updates Study Supply Plans in close communication with CSO project Managers.

Responsible for the Clinical Label Development process which includes creation of master label text, translations, and label proofs.

Manages CMO documentation reviews (i.e, 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.

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.

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 PM in executing additional operational and logistical duties as discussed and agreed to by management.

Acts as point of contact for operational clinical supply matters during the course of a clinical trial including facilitating the review of temperature excursions.

Skills:

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/CMO's.

Experience managing multiple vendors per project required.

Import/export knowledge desirable.

Working in a matrixed environment

Excellent communication, negotiating, and computer skills.

Strong team orientation.

Experience with IRT highly preferred

Keywords:

Education:

BS/BA required.  Degree in pharmacy or related field preferred.  MS or PharmD highly beneficial.

To apply for this position please send resume to:

Vickie Dagit, Recruiter at vdagit@apexlifesciences.com  

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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