Senior Specialist, Pharmaceutical Labeling Artwork

Job Description

The role of Senior Specialist, under the supervision of the US Market Artwork Team Lead, as a Labeling Artwork Lead is responsible for:

• Develop and revise artwork for US market for NDA/BLA submissions/supplements to FDA, production needs and human factors testing.

• Revise artwork for WHO submission and production.

• Initiate artwork projects in Artwork Management System and review and approve composed artwork.

• Coordinate the end-to-end US artwork development process for labeling and work cross-functionally with CMC and manufacturing sites to implement new or revised labeling.

• Support Artwork in product launches and unique or complex artwork execution.

• Work with a cross-functional team to enable artwork reviews and drive consensus, ensuring all appropriate stakeholders are aligned.

• Participate in creation of FDA response documents and meetings when necessary.

• Provide labeling components for NDA/BLA Annual Reports

• Participate in special project assignments related to artwork and related labeling when needed.

Education:

• Bachelor’s Degree is required

Required Experience and Skills:

• Minimum of 4 years pharmaceutical/biological labeling artwork experience or relevant professional experience. 

• Regulatory submission and approval experience

• Expertise in labeling regulations, and artwork processes

• Detail oriented, well organized, and excellent planning and prioritization skills. 

• Experience leading teams, driving consensus and results. 

• Excellent communication, interpersonal and collaboration skills.

Preferred Experience and Skills:

• Experience and knowledge of supply chain

• Medical Device & Combination Product Labeling

• Adobe Creative Suite and Microsoft Office

• Perigord and Docu-Proof

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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US and Puerto Rico Residents Only:

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