Address: Paramus, NJ 07652
Telephone: 901-207-8038
Email Address: smithassociates1725@gmail.com
Hours: Office Hours – 3:30 PM – 8:00 PM CST
Company is in search for a Clinical Supply Manager to join their team.
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Position Title : Clinical Supplies Manager
ATTENTION : ” $TOP PAY “( Interviewing Now )
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Location : Paramus, NJ
Salary : Competitive (DOE)
– Experience level: Mid-senior
– Experience required: 8 Years
– Education level: Bachelor’s degree
– Job function: Management
– Industry: Pharmaceuticals
– Total position: 1
– Relocation assistance: No
– Visa sponsorship eligibility: No
SUMMARY OF POSITION :
– Assist and support the Associate Director in managing Contract
Development and Research Organizations (CDMO) in the areas of Clinical
Supplies.
– Review master batch records (MBR), Master Packaging Work Orders
(MPWO), and clinical related supplies-related documents.
– Assist and support the review of packaging, labeling, storage, logistics,
and distribution documentation of the investigational product.
– Assist and support the management of clinical supply inventories using
Interactive Response Technology.
– Expected to prepare data tables when needed for data interpretation.
– Assist with documentation and process internal and external change
controls.
– Assist and support clinical supply activities for investigational products,
such as import and export, customs clearance, DEA Controlled Drug
experiences, etc.
KEY RESPONSIBILITIES : Technical Management
– Assist collaborated team to prepare clinical supplies request forms for new
and existing studies when it needs it.
– Prepare requests for proposals for activities in support of clinical supply
projects.
– Review CDMO Project proposals and provide feedback to the
Associate Director before selecting a specific vendor, review and audit slides,
tables, and budget calculations.
– Assist and prepare CDMO Vendor Comparison slides and assist in the
selection of an appropriate CDMO based on technical ability, cost, and ability
to deliver on time.
– Provide technical support for vendor’s IRT/IWRS system in support of SK
clinical studies.
– Utilize inventory forecasting software to ensure an adequate amount of
CTMs is available to supply clinical sites when needed.
– Assist and support in writing and preparation of regulatory submission
documents: drug product and drug substance sections in IND, Annual reports,
and Informational amendments.
Financial Management :
– Prepare Ariba process for internal budget approval of new/ongoing CMC
Team projects.
– Prepare, maintain, and monitor project budgets for the CMC Team
– Review and process clinical supply CMO invoices for project activities.
– Prepare and assist the FP&A team on project-specific spending and accrual
monthly and quarterly basis, if requested.
– Participate in project budgeting and forecasting process for the CMC Team’s
annual project budget management activities.
QUALIFICATIONS:
1. Bachelor’s degree in chemistry (preferred analytical) and up to 5-8 years of
experience working in an analytical laboratory background.
12. Ability to understand, maintain, and demonstrate troubleshooting on
vendor’s IRT/IVRS system, a plus.
For consideration you must act now, send resume to
smithassociates1725@gmail.com. Sincerely,
Gerald Smith
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