Clinical Supplies Manager Job

Company Name:
Salary period: Annual
Clinical Supplies Manager needed for a contract opportunity with Yoh's client located in Woodcliff Lake, NJ.
What You'll Be Doing:
- 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.
What You Need to Bring to the Table:
- 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 Pharmaceutical 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
Opportunity is Calling, Apply Now!
Recruiter: Krista Leach
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Click here to contact us if you are an individual with a disability and require accommodation in the application process.

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