Clinical Supply Specialist – Green Key Resources – San Francisco, CA, USA
Education: A minimum of a Bachelors degree in a scientific discipline is required. Equivalent experience may be accepted. A minimum of 5 years’ experience in the pharmaceutical or other related regulated industry is required. A thorough understanding of the FDA and cGMPs is required. Must have a thorough knowledge of areas impacting Clinical Supply Management and the Supply Chain such as, Finance, Quality, Engineering, Manufacturing, and Facilities. Experience and familiarity with cGMP practices and knowledge of CFR, ICH, CDER guidelines for storage, handling, and distribution of drug products, experience with IVRS systems is required. Experience in refrigeration materials (cold chain management) and controlled drug substances is preferred. Knowledgeable in global import/export requirements. Experience in successful management of relationships with contract service providers is required. Must be able to adhere to strict (or changing priority) project timelines and work independently with minimal supervision. The candidate should have good communication skills (oral and written), strong initiative, be highly motivated and ability to work in a fast-paced, dynamic environment.
Duties: Coordinates aspects of pharmaceutical clinical drug supply logistics. Provides support to clinical trial material supply planning and distribution. Actively supports the forecasting, planning, scheduling, coordination, and implementation of clinical supplies for multiple projects, which may involve controlled substances and global distribution. Responsibilities also include labeling, packaging, storage, distribution, disposal, and final reconciliation of products across the Client development pipeline of oral and parenteral dosage forms.
Skills: Supports and maintains forecasts for clinical trial materials. Coordinates definition of drug product for packaging, assess product dating, storage conditions, primary components, analytical testing needs, and retain quantities. Collaborates with Clinical Operations to develop, implement, and maintain IVRS. Works with Biostatistics to determine requirements for randomization and material codes and ensures the packaged drug products are consistent with the code assignments. Defines and obtains approval for the labeling and packaging requirements for Client products for clinical development in the United States and other countries. Works with Quality to ensure supplies are prepared in accordance with applicable GMP and GCP regulations, US and global requirements as well as DEA regulations. Works closely with Accounting to review and approve invoices, and works closely with Supply Management and with suppliers to reconcile invoices. Ensures timely review and disposition of suppliers’ invoices. Manages Purchase Orders and monitors supplier’s performance against each contract, including cost tracking for each PO/contract.