Sr. Clinical Supplies Manager
Based in NJ
- 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.
- Supervise and mentor Associate(s) in Clinical 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.
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 an extremely exciting 12+month Consulting Assignment and competitive hourly rate.