Responsible for providing overall global coordination of the entire clinical supplies lifecycle for the projects assigned. Responsible for managing the full spectrum, least complicated to highly complex, without guidance. These studies require primary and/or secondary packaging and labeling design, drug projections, drug distribution and returns, drug inventory management, budgeting and developing project specific material for multiple projects at the same time. Provides consultation services to clients regarding global packaging, labeling, and distribution requirements. Serves as the groups lead consultant to clients regarding global packaging, labeling, and distribution requirements. Serves as the main point of contact between the client, clinical project teams, third party vendors, and study sites for entire programs that may include up to 5-10 individual studies. Act as mentor to junior level Global Supply Project Managers.
The Global Clinical Supplies Department consists of approximately 75 employees located in all regions of the world. This role contributes to the overall strategic objectives of the department by completing assigned objectives in a timely and error free manner and offering our internal and external clients innovative clinical supplies management services.
Education and Experience:
- Bachelor's degree in a science or related discipline
- 8-10 years in clinical research industry, specifically in the area of Clinical Supplies, Clinical Development, QA/Regulatory Affairs.
- Familiar with clinical supply terminology and practices and principles.
- Familiar with protocol interpretation and packaging and labeling design
- Familiar with cGMP, GCP, and ICH knowledge and experience essential
Knowledge, Skills and Abilities:
Skilled in bid preparation and defense
Strong working knowledge of the drug development process with demonstrated understanding of the following practices:
- Drug formulation
- Analytical method development
- Stability profiles and concepts
- Bulk drug manufacturing practices
Very strong communication skills both written and verbal.
Excellent interpersonal skills and problem solving/decision making skills.
Demonstrate effective leadership and team building skills.
Strong computer skills: working knowledge of Microsoft Project, Excel, and Microsoft Word is required.
Strong organizational skills required.
Strong multi tasking skills required.