Senior Clinical Supplies Manager
1 Year Contract – NJ
Medical Affairs Global Neuroscience Business Unit
- Manage all aspects of clinical supply packaging and labeling for a wide range of studies – includes relationship management with 3rd party vendors.
- Manage timelines for Clinical Supplies – both internally and externally.
- Review protocols and provide innovative solutions for packaging and labeling of the studies,
- Create globally compliant label text and coordinate regulatory certification and translation.
- Ensure regulatory, patient and site compliance of the drug supplies.
- Oversee and track re-test dates for all products at 3rd party vendors, investigational sites, labs etc.
- Evaluate and select new clinical supply packagers (includes attending GMP audits of the facilities)
- Maintain and improve understanding and knowledge of global regulations associated with clinical supplies.
- Build relationships with study team members and facilitate communication between Clinical Supplies and study teams.
- Identify areas of improvement within Clinical Supplies – propose and implement improvement strategies.
- Facilitate communication with other sites and build global relationships.
- Present on Clinical Supplies to study teams and at kick-off/investigator meetings as required.
- Bachelor of Science degree in a relevant scientific discipline and 5 to 7 years broad pharmaceutical industry experience, including line management experience and outsourcing management.
- Previous experience in Pharma or Biotech industry in clinical supplies.
- Knowledge of Global clinical supplies/packaging regulations preferred.
- Experience with Neuroscience a plus, not required.
- Good knowledge of regulatory documents; domestic and international regulatory requirements (including ICH and GCP guidelines)
- Exceptional organizational, time management and attention to detail skills
- Extremely proficient computer skills including MS Word, Lotus Notes, and Documentum
- Strong verbal, written and interpersonal communication skills, especially needed to work effectively in a cross-functional team environment
- Good knowledge of the drug development process
- Able to develop strong relationship with functional areas
- Provide innovative packaging and labeling recommendations/solutions
Company offers very competitive hourly rate for contract role.