Medical Labeling Lead
Cincinnati, OH Posted: 5/8/2019
Our client is a global contract research organization supporting data management, biostatistics, statistical programming, clinical operations, regulatory affairs, safety, pharmacovigilance, toxicology, medical affairs, medical writing, quality, risk, and compliance services to the pharmaceutical, biotechnology, and medical device industries worldwide.
Medical Labeling Lead - This is full time permanent role with our client located in Cincinnati, OH.
They are seeking a talented Medical Labeling Lead to serve as single point of contact and coordinate global labeling activities including with offshore team. Duties include;
- Coordinate between stakeholders / SME's and Supplier offshore team
- Undergo the primary knowledge transfer of labeling application(s) and successively train the offshore team
- Tracking and maintaining deliverables for planning and conducting offshore transition & training sessions
- Interact with Client, understand their requirement & provide delivery team with client expectations
- Work closely with outside services such as translation houses, service bureaus, design houses and consultants as needed.
- Coordinate and lead plan progression meetings and vendor (printers) concurrence on drawings
- Work closely with project leaders on collaborating and collecting the right inputs
- Serve as the primary resource accountable for leading New Product Development, Lifecycle Management and Process Improvement projects for Product Labeling
- Ensure systems interface to schedule design, approve and release artwork for all labelling
- Proactively identify opportunities to improve/enhance labeling systems and processes
- Documentation and maintaining of labeling procedures, change orders and Vendor follow up including Graphic design, updates and conversion of labels
- Project coordination including setting up of offshore team and Manage regular labeling deliverables and other related activities
- Review and inspection of content accuracy and Update drawings for labeling
- BS/BA Degree or equivalent education/experience
- Four plus years related experience in medical labeling preferably in the Consumer Products, Pharmaceutical, Biotech or Medical Device industry
- Effective interpersonal, organizational and communication skills with strong attention to detail
- Strong understanding of FDA and industry regulations and labeling guidelines
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