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