Title: Clinical Labeling Operations
Contract: 18 Months
Pay: $57.44/hr. on w2
Onsite-
Location: Full list of preferred locations (ranked in order of preference) is within 50 miles of:
- Thousand Oaks, CA
- El Segundo, CA
- Frederick, MD
- Oceanside, CA
- Foster City, CA
Essential Functions:
- Responsible for the coordination of new clinical labeling implementation with Regulatory Affairs Labeling, Quality Assurance Labeling, Supply Chaing Labeling BPO, PM’s and multiple packaging sites worldwide.
- Creates labels content and maps content to the appropriate fields in Bartender
- Creates Business Continuity Labels and maps contents to the appropriate fields
- Reviews clinical final product label content and Bartender mapping to ensure all content matches source documents and text is mapped to the appropriate fields.
- Liaises with Regulatory Affairs Labeling colleagues to obtain correct text, negotiate timelines and ensure that all requirements have been met.
- Manages the completion of operational excellence projects where prior precedents may not be set and outcomes require executing without prior experience.
- Authors standard operating procedures, guidelines and work instructions.
- Collaborates with team members to meet departmental goals and objectives.
- Completes labeling updates as assigned.
Knowledge, Experience and Skills:
- Highly capable at directing and coordinating project work. Strong verbal, technical writing and interpersonal skills.
- Proficient in Microsoft Office applications. Knowledge of FDA and cGMP standards as well as regulatory guidance documents.
- Prior experience in pharmaceutical or other regulated industry is required.
- Prior experience in clinical or commercial supply chain
- Familiarity with artwork/labeling production.
- Familiarity with Bartender software is bonus.
- 6+ years of relevant experience and a BS or BA or 4+ years of relevant experience and a MS.