This specialty biopharmaceutical client understands the importance of recruiting the very best people at every level of the organization. They emphasize a culture that encourages teamwork and achievement. Bureaucracy has no place in their culture.

This individual will play a key role in coordinating the development of new drug delivery applications through clinical research. The candidate will have responsibility for developing plans, timelines and budgets. Will ensure other team members are aware of assignments and deliverables. Will collaborate with peers and others to develop effective regulatory strategies, identify vendors and their capabilities , negotiate and manage contractors and their performance, and report project status to senior management. Will participate in drug development plans and coordinate and manage their implementation. Responsible for meeting aggressive timelines.

Requires a BS degree (MS or MBA preferred) in a biomedical or related science and at least 5 years experience in project management and drug development in an FDA environment. Must have current knowledge and experience with project management tools (PMP certification preferred). Must be experienced in GCPs and FDA requirements for drug development and approval. Effective communication, leadership, documentation and computer skills are expected, as well as a collaborative approach to working with colleagues and other groups.