Meet is partnering with an exciting midsized biotech company 25 years ago currently with about 500 employees. They are an oncology focused business with 3 commercial products on the market. These products generate a revenue stream which has turned them into a very profitable business. With those profits they have reinvested that back into the business being able to expand their R&D, allowing them to build out new Bio and Chem labs. They have multiple partnerships with big names in the industry and are looking for a Director of Process, Standards, and Training who would support the process and training management for Development Operations. Any seasoned professional looking to get their foot in the door at this great company with a contract to hire opportunity is encouraged to apply.
• Co-lead Development Operations training curricula activities.
• Partners in Root Cause Analyses and advises on content for training and knowledge management initiatives.
• Identifies and supports remediation issues related to training assigned to Development Operations functional areas.
• Identifies and develops shared solutions across Development Operations for formal and informal competency development, and learning/knowledge sharing, to increase productivity and performance.
• Develops and reports metrics to reflect progress and status of training activities.
•Facilitate review of SOPs and WI
• Develop new processes to complement our maturing organization with expanded pipeline
• Collaborate with functional heads and Quality to refine role-based training curriculum
• Evaluate company’s CROs procedures with a formal gap assessment
• 10+ years of related experience and/or combination of experience and education/training.
• 10+ years of pharmaceutical/biotechnology/CRO in quality management of clinical trials, training, clinical operations, project management.
• Advanced knowledge of ICH-GCP guidelines and applicable drug development regulations.
• Advanced experience with training development and implementation required.
• Experience with training methodologies and design.
• Experience in supporting clinical trial GCP compliance/quality management activities.
• Strong understanding of drug development and clinical trial execution, including other required functional areas involved in clinical trials.
All interested parties are encouraged to apply!
Everything discussed will remain confidential.