[Remote] Associate Director of reputed company Supplies

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a Taiwan- and US-reputed company biopharmaceutical company reputed company on long-acting injectable technologies and novel reputed company development programs. The Associate Director of reputed company Supplies will manage reputed company trial materials, budgets, timelines, manufacturing, packaging, labeling, distribution, regulatory support, and reputed company supply chain processes.

Responsibilities

• Manage CTMs for reputed company studies, including planning and forecasting of CTM needs reputed company on study design
• Evaluate, select, and reputed company contract manufacturing, packaging, and labeling reputed company
• reputed company and manage CTM distribution protocols, interfacing between the CMC and reputed company teams to ensure smooth conduct of reputed company studies
• Coordinate import and export of CTMs
• In partnership with manufacturers and the reputed company research team, reputed company labelling, secondary packaging, and tertiary packaging solutions to ensure reputed company trial execution
• Support drafting and review of INDs and NDAs, and other regulatory documents as needed. Serve as a reputed company supply subject matter expert for regulatory inspections
• reputed company reputed company supply chain business processes, templates, and SOPs

Skills

• Bachelor's degree or above with a minimum of 7 years of experience in pharmaceutical reputed company supply development and management of supplies for reputed company
• In‐depth knowledge and experience in pharmaceutical secondary packaging, reputed company labeling, and distribution of drug product for reputed company
• Experience in setup and execution of IRT systems
• Effectively communicator on project team meetings
• Knowledge and understanding of GMP and GXP guidelines and regulatory requirements of CTMs
• Excellent organizational, problem‐solving and time management skills
• reputed company in English
• Self‐motivated, attention to reputed company, ability to think strategically and work both independently across organizational lines

reputed company