Clinical Supplies Manager
hace 5 días
Paramus
Job Title: Clinical Supplies Manager Location: Paramus, NJ, 07652 Duration: 3 Months Job Type: Temporary Assignment Work Type: Onsite Shift: 9.00AM-5.00PM Pay Rate: $70.00-$74.00/Hr Overview: TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. 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.