Clinical Supplies Manager

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide.

Job Title: Clinical Supplies Manager

Location: Paramus, NJ, 07652

Duration: 3 Months

Job Type: Temporary Assignment

Work Type: Onsite



Shift: 9.00AM-5.00PM

Job Description:

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.

• Manage and processing of CMC Team project invoices and internal project budget requests (ARIBA), and monitoring of project financial tracking.

• Assist and support Regulatory Affairs (RA) to provide any documents for their submissions (US and Global).

• Assist and support the Quality Assurance Unit (QAU) regarding the review of investigations and conduct vendors and internal audits.

• Assist and support Clinical Operations on document reviews related to the study specifics, such as pharmacy manual, study protocols, investigational brochures, etc.

Responsibilities:

Technical Management

• Assist collaborated team to prepare clinical supplies request forms for new and existing studies when its need 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 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.

• Assist and support in writing and preparation of SOPs and interpreting and reviewing SOPs and study protocols.

• Review manufacturing, packaging, and labeling Master and Executed Packaging Work Orders/Batch Records (MBR/EBR, Packaging Labeling Approval Forms (PLAF), Labeling Approval Forms (LAF), etc.

• Assist and prepare Excel tables when needed.

• Assist in the maintenance of SOPs related to reflecting current clinical supply activities.

• Assist and support Investigational Product Returns and Reconciliation at the end of the studies and collect all necessary documentation from vendors.

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:

• Bachelor's degree in chemistry (preferred analytical) and up to 5-8 years of experience working in an analytical laboratory background. Ability to read, analyze, and interpret basic scientific protocols, reports, and technical journals. Also, should be able to interpret financial reports.

• Expert technical skills, good organization skills, ability to follow directions, and good communication skills.

• Computer aptitude is a plus, especially proficiency with Microsoft Office, and in particular use of Excel and the ability to plot data.

• Understand protocols, write SOPs, and have technical knowledge of packaging and labeling activities.

• Knowledge of pharmaceutical stability protocols, assessment of expiration dating for investigational drug products

• Knowledge of GMP batch record development, review, and approval process

• Demonstrated understanding of the entire supply chain and associated cost drivers

• Ability to execute the Clinical Supply portion of User Acceptance Testing (UAT) for the IRT system.

• Knowledge of GCP and global cGMP regulations, (knowledge of EU GMP QP regulations is preferred), a plus.

• Knowledge of warehousing, distribution (including cold chain distribution), and logistics, a plus.

• Ability to review, analyze, and interpret the IVR/IRT reports and specification requirements, a plus.

• Ability to understand, maintain, and demonstrate troubleshooting on vendor's IRT/IVRS system, a plus.

TekWissen Group is an equal opportunity employer supporting workforce diversity.