Labeling Project Coordinator
Proclinical is currently recruiting for a Labeling Project Coordinator with a pharmaceutical company located in Santa Monica, CA. A successful candidate will have project management experience, change controls, clinical labeling/label designs, knowledge of GDP, cGMP, & FDA standards, and a Bachelor's degree or higher.
- 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.
- Interacts with internal cross-functional teams to provide input into labeling options.
- Engages the clinical labeling group to meet company goals including department improvement projects.
- Works 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.
Skills and Requirements:
- Strong computer and organizational skills required.
- Project and document management experience.
- Experience with Change Controls.
- 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.
- Prior experience with clinical labeling, including the technical aspects of label design.
- Requires a Bachelor's degree and a minimum 2 years of relevant industry experience preferably in clinical labeling or regulatory roles.
If you are having difficulty in applying or if you have any questions, please contact Catherine Nguyen at 215-531-5643.
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.