Clinical Labeling Associate – Investigational Product Labels & Artwork (Remote, US)

Spark CMC Consulting is a life sciences consultancy supporting biotech and pharma clients with CMC and regulatory documentation. We’re looking for a Clinical Labeling Associate to support a client’s clinical-stage development programs on a contract basis. Responsibilities Manage and update investigational product label text and artwork through review and approval cycles, working with the client’s packaging and labeling vendor. Keep approved label text consistent with related submission documents, including the Investigator’s Brochure, protocol, and CMC sections such as stability data and expiry dating. Track label versions, change requests, and approvals so every update is documented and traceable. Proof label drafts and artwork against approved text and flag discrepancies before they reach print. Maintain labeling records in line with GMP documentation standards. Work with the client’s regulatory affairs, medical writing, clinical operations, and CMC teams. Qualifications 2–5 years of hands-on experience with clinical trial (investigational product) labeling, not only commercial labeling. Experience preparing or reviewing clinical label text for multi-country studies, including EU CTR Annex VI and US 21 CFR 312.6 requirements. Experience proofing label artwork and managing version control through review cycles. Based in the US and able to work remotely during US Eastern business hours. Nice to have Experience at a clinical packaging and labeling provider or in a clinical supply chain role at a biotech. experience supporting just-in-time (JIT) labeling. Familiarity with booklet labels, expiry date extensions, or relabeling driven by stability updates. Exposure to labeling or proofing tools such as Prisym, Veeva, GlobalVision, or similar. Engagement details Contract, hourly (1099). Rate: Hourly rate, dependent on experience. Fully remote, US-based. Pay: From $50.00 per hour Work Location: Remote

View the full posting and apply