Sr. Clinical Supply Manager

A biotechnology client is looking for a Sr. CMC Medical Writer. The position is 100 % Remote.

Overview

• This position will assist and support Associate Director in managing Contract Development and Research Organizations (CDMO) in the areas of Clinical Trial Material (CTM) manufacturing. The management of these activities involves review of master batch records (MBR), Master Packaging Work Orders (MPWO), protocols, and reports; documentation, archiving, and processing internal and external change controls, preparation of data tables when needed for data interpretation
• The candidate will also be supporting management of clinical supply inventories and manage IRT/IVRS. The candidate is expected to communicate with Clinical Operations on routine basis to understand the current and future scope of the clinical trial and convey the clinical supplies need to plan future manufacturing, packaging, and labeling. Experience in use of related software tools is expected.
• This position is expected to verify completion of work, manage and process invoices and internal project budget requests (ARIBA), and monitor work specific budget.

Responsibilities

1. Technical Management

• Manage study specific US and global /ROW clinical supply management
• Assist and prepare CRO/CMO Vendor Comparison slides and assist in the selection of an appropriate CRO/CMO
• Provide technical support for vendor’s IRT/IVRS system in support of SK projects
• Utilize inventory management and forecasting software to ensure adequate amount of CTMs are available to supply clinical sites.
• Review manufacturing, packaging, and labeling Master and Executed Packaging Work Orders/Batch Records, Packaging Labeling Approval Forms (PLAF) and Labeling Approval Forms (LAF)

2. Financial Management

• Prepare requests for proposals for the clinical supply projects; including preparation of Ariba PR and PO, and PR-Amend of Clinical Supply proposals, contracts change of scope, SOWs
• Review CRO/CMO Project proposals and provide feedback to manager prior to selecting the vendor; review and audit slides, tables, and budget calculations
• Prepare Ariba process for internal budget approval of new/ongoing CMC Team projects
• Prepare, maintain, and monitor project budgets for CMC Team
• Review and process clinical supply CMO invoices for project activities
• Prepare and assist FP&A team on project specific spending and accrual monthly and quarterly base, if requested.
• Participate in project budgeting and forecasting process for the CMC Team annual project budget management activities

3. Additional Responsibilities

• Assist in archiving of clinical supply documents
• Assist in writing and preparation of regulatory submission documents: drug product and drug substance sections in IND, Annual reports, and Informational amendments
• Assist in writing and preparation of SOPs and interpreting and review of SOPs and protocols

Qualifications

Education:

• Bachelor’s degree up to 5 -8 years’ experience working in a in clinical supplies environment.

Experience:

• Ability to understand, maintain and demonstrate troubleshooting on vendor’s IRT/IVRS system.
• 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 have good communication skills. Computer aptitude a plus, especially proficiency with Microsoft Office, in particular use of Excel.
• Understand protocols, write SOPs, and 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 entire supply chain and associated cost drivers
• Experience that would be a plus:
• Ability to execute Clinical Supply portion of User Acceptance Testing (UAT) for IRT system.
• Knowledge of GCP and global cGMP regulations, (knowledge of EU GMP QP regulations is preferred).
• Knowledge of warehousing, distribution (including cold chain distribution), and logistics.
• Ability to review, analyze and interpret the IVR/IRT reports and specification requirements.
• Experience in using inventory and forecasting software.