[Close] 

Clinical Supplies Manager Job

Company Name:
Arca24.com
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.
J2W: CLINICAL
MONJOB
J2WMIDATL
Ref:
SFSF: LS

Don't Be Fooled

The fraudster will send a check to the victim who has accepted a job. The check can be for multiple reasons such as signing bonus, supplies, etc. The victim will be instructed to deposit the check and use the money for any of these reasons and then instructed to send the remaining funds to the fraudster. The check will bounce and the victim is left responsible.