Labeling Project Coordinator - II
Proclinical is currently recruiting for a Labeling Project Coordinator for a biotechnology company located in Santa Monica, CA. Successful candidate will work collaboratively with other members of Clinical Labeling, Quality, Clinical Operations, Package Engineering, Supply Chain, Regulatory and Project Management staff to meet project deliverables.
- Responsible for processing clinical labeling documents and completing activities associated with multiple clinical development programs. These include but are not limited to label generation and approval per regulatory guidelines.
- Interact with Kite internal cross-functional teams to provide input into labeling options.
- Engage the clinical labeling group to meet company goals including department improvement projects.
- Work closely with ancillary groups to process and approve GMP documents Authors and reviews documents to ensure GMP compliance.
- Responsible for change control task closures and preliminary assessments.
- May participate in other Clinical Supply chain roles.
Skills and Requirements:
- Prior experience with clinical labeling, including the technical aspects of label design, is preferred.
- Bachelor's degree and 2+ years' relevant industry experience preferably in clinical labeling or regulatory roles
- Excellent verbal, written, and social communication skills are required.
- Strong computer and organizational skills required.
- Project and document management experience a plus.
- Experience with Change Control is beneficial.
- Able to anticipate client obstacles and difficulties and act upon this in order to meet goals.
- Ability to write clear, concise and error-free documents.
- Able to exercise discernment within defined procedures and policies in order to resolve and take appropriate action.
- Possess a knowledge of the GDP, cGMP, FDA standards as well as regulatory mentorship documents such as Annex 13.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Brendan Thalheimer at (+1) 215-531-5299 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.