Overview:

TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. The below job opportunity is with one of our pharmaceutical and healthcare clients, whose purpose is to reimagine medicine to improve and extend people's lives. They use innovative science and technology to address some of society's most challenging healthcare issues. They discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible.

Job Description:

• Responsible for supporting compliant and efficient regulatory submissions through the creation, management and approval of Sandoz product labeling artwork in accordance with applicable procedures and standards.
• Responsible for preserving a consistent look-and-feel throughout the technical design and development of labeling materials, protecting existing approved brand guidelines in all creative development.
• Support development of artwork for a variety of regulated products, including pharmaceuticals, medical devices, and combination products.
• Responsible for organizing and archiving all creative files in accordance with Sandoz current practice.
• Must have the capacity to create original line art to be used as instructional images in Patient Information labeling.
• Demonstrated accuracy and attention to detail when finalizing artwork and creating files; must have experience with proofreading and redline documents.
• Must have an excellent grasp of printing and production processes that result in setting up print files properly for our print vendors.
• Responsible for clear and direct communication, both written and verbal; ability to gather customer inputs, incorporate feedback, and set expectations for project delivery.
• Must have exceptional organizational and time management skills, an excellent level of productivity, and the flexibility to respond to changing deadlines
• Must be an independent, organized worker with high attention to detail who is able to set priorities and manage multiple projects with minimal supervision.
• Ability to work and collaborate with onsite and remote team members to obtain and complete artwork jobs.
• Basic understanding of the Regulatory requirements for labeling artwork including, but not limited to, PLR requirements (21 CFR 201.56 and 201.57), NDC placement (21 CFR 201.2), established and proprietary name requirements (21 CFR 201.10) and Drug Facts (21 CFR 201.66) wherever necessary.

Education:

• bachelor's or associate degree in graphic design or other related field.

Experience:

• bachelor's degree plus a minimum of 4 years in the pharmaceutical industry with 2 years of those years in regulatory affairs artwork creation.
• Associate degree plus a minimum of 6 years pharmaceutical industry experience with at least 4 years in regulatory affairs artwork creation.
• Experience designing for both print and digital platforms Using Adobe Creative Suite (Illustrator and In- Design) and barcoding software.
• Must have experience using design software on MacBook and PC optional.
• Familiarity with Microsoft Office Suite, SharePoint and Text Verification Tool (TVT) a plus.

TekWissen® Group is an equal opportunity employer supporting workforce diversity.

Job Types: Full-time, Contract

Pay: $50.00 - $56.00 per hour

Application Question(s):

• Do you have Experience designing for both print and digital platforms Using Adobe Creative Suite (Illustrator and In- Design) and barcoding software.?
• Do you have Basic understanding of the Regulatory requirements for labeling artwork including, but not limited to, PLR requirements (21 CFR 201.56 and 201.57), NDC placement (21 CFR 201.2), established and proprietary name requirements (21 CFR 201.10) and Drug Facts (21 CFR 201.66) wherever necessary?

Experience:

• Pharmaceuticals: 1 year (Preferred)
• regulatory affairs: 1 year (Preferred)

Work Location: Hybrid remote in Newark, NJ 07102

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