Coordinate global clinical labeling implementation, map and validate label content in Bartender, partner with Regulatory Affairs and quality teams, author SOPs and process improvements, and support labeling updates to ensure compliance with FDA, cGMP, and company requirements.
Our client, a world
leader in biotechnology and gene therapy, is looking for an Clinical
Labeling Operations Specialist (100% Remote).
Job Duration: Long
Term Contract (Possibility Of Extension)
Pay Rate : $56.79/hr on
W2
Company Benefits: Medical, Paid Sick
leave, 401K
The Labeling Operations
Specialist coordinates the implementation of new clinical labeling and labeling
updates across Regulatory Affairs, Quality Assurance, Supply Chain, project
teams, and packaging sites worldwide. This role ensures label content is accurately
transferred, mapped, reviewed, and implemented in accordance with source
documents, FDA requirements, cGMP standards, and applicable regulatory
guidance.
Key Responsibilities
- Coordinate
global clinical labeling implementation with Regulatory Affairs, Quality,
Supply Chain, PMs, and packaging sites.
- Create
and map label content within Bartender and develop Business
Continuity Labels.
- Review
final product label content and mapping for accuracy and alignment with
source documents.
- Partner
with Regulatory Affairs to obtain approved text, manage timelines, and
ensure requirements are met.
- Lead
operational excellence and process improvement projects.
- Author
and update SOPs, guidelines, and work instructions.
- Support
labeling updates and collaborate cross-functionally to meet departmental
objectives.
Required Qualifications
- Bachelor’s
degree with 6+ years of relevant experience, or Master’s degree
with 4+ years of relevant experience.
- Experience
in the pharmaceutical or other regulated industry.
- Experience
with clinical or commercial supply chain operations.
- Familiarity
with pharmaceutical artwork and labeling production.
- Knowledge
of FDA regulations, cGMP standards, and regulatory guidance.
- Strong
project coordination, communication, technical writing, and interpersonal
skills.
- Proficiency
with Microsoft Office.
Preferred: Experience with Bartender
software and label content mapping.
If interested, please
send us your updated resume at
[email protected]/[email protected]
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