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Seagen
Senior Associate Product Labeling
Product Supply Operations - Bothell, Washington - US Field Based
Description
Summary
The Senior Associate, Product Labeling role will be responsible for creation and maintenance of the Seagen catalogue of product labeling alongside the Product Labeling team. Attend and participate in label design meetings with internal and external stakeholders, and have an understanding of domestic and international pharmaceutical labeling regulations. Working knowledge of clinical and commercial product labeling requirements.
Principal Responsibilities:
- Research new regions for clinical and commercial labeling requirements and ongoing regulatory changes
- Create and maintain commercial & clinical labeling for current and pipeline programs in support of regulatory submission to the authorities
- Support the design of all labeling to parameters of corporate branding
- Utilize proofing of labeling materials using manual and electronic proofing tools
- Manage multiple projects concurrently, while complying with good manufacturing practices (GMPs), regulatory, quality systems standards and labeling requirements.
Required Qualifications:
- 4-6 years in FDA/Regulatory Affairs graphic design
- Professional experience in pharmaceutical labeling with knowledge in print technologies, graphics & artwork pre-press technologies
- Knowledge of packaging process and operations
- Flexibility to manage constantly shifting deadlines, varying deliverables, and communication complexities
- Knowledge in GS1 barcode standards
- Adobe - Creative Suite
Preferred Qualifications:
- BS/BS Degree in a business/life science field or graphic design
- Previous experience in GMP manufacturing environment
As the leading employer in our industry in the Pacific Northwest, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seagen, please visit www.seagen.com.
Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.
Apply:
Seagen
Seagen is an Equal Opportunity Employer
Submitted: 01/22/2021
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