Overview
Pharmaceutical Labeling Consultant Jobs in United States at Biotech Partners
Title: Pharmaceutical Labeling Consultant
Company: Biotech Partners
Location: United States
We are seeking a Part-Time (10-20 hours/week) Remote Consultant – Pharmaceutical Labeling Specialist to support the design, creation, and management of labeling materials, including label inserts, Instructions for Use (IFU), United States Prescribing Information (USPI), and Summary of Product Characteristics (SmPC). This role is fully remote and requires a detail-oriented professional with expertise in graphic design and pharmaceutical labeling regulations.
As a key contributor, you will collaborate with cross-functional teams to ensure our labeling materials are accurate, compliant, and visually optimized for readability.
Responsibilities
Graphic Design and Production:
Create and format graphic layouts for label inserts, IFUs, USPI, and SmPC using design software such as Adobe Illustrator and InDesign.
Ensure designs are compliant with regulatory and company standards, prioritizing readability and usability.
Regulatory Compliance:
Collaborate with regulatory teams to incorporate updates from the FDA, EMA, and other health authorities.
Ensure all labeling materials meet applicable regulatory guidelines and standards.
Content Validation:
Proofread and validate labeling content, including dosing instructions, warnings, and legal disclaimers.
Manage version control and track updates to ensure timely implementation of changes.
Collaboration:
Work with teams in Regulatory Affairs, Quality Assurance, Marketing, and Supply Chain to ensure labeling alignment with overall product requirements.
Coordinate with manufacturing teams to confirm compatibility with packaging specifications.
Technical Review:
Conduct mock-up testing to verify printability and layout consistency on physical packaging.
Validate the accuracy of graphical elements, such as barcodes and expiration dates.
Documentation and Record-Keeping:
Maintain detailed records of labeling revisions, approvals, and documentation in compliance with Good Documentation Practices (GDP).
Process Improvement:
Identify and recommend improvements in labeling processes to enhance efficiency and compliance.
Qualifications
Experience:
Minimum of 5 years of experience in pharmaceutical labeling, regulatory affairs, or graphic design for labeling materials.
Previous experience creating and managing labeling materials for the FDA and EMA is strongly preferred.
Technical Skills:
Proficiency in graphic design tools such as Adobe Illustrator, InDesign, and CorelDRAW.
Familiarity with document management systems and version control tools.
Regulatory Knowledge:
In-depth understanding of FDA and EMA labeling regulations for USPIs, IFUs, and SmPCs.
Other Skills:
Strong attention to detail and proofreading skills.
Excellent communication and collaboration abilities.
Ability to work independently and manage multiple projects within deadlines.
