Specialist Global Labeling Operations

Purpose

Global Responsibility for operations labeling project execution within a highly cross functional environment and key subject matter expert on regulatory manufacturing and commercial labeling considerations to ensure the Global Label Management organization meets its performance objectives. The position will lead workflow coordination within artwork production and has responsibility for key tasks within artwork projects specific to (technical) redlining technical documentation commodity code assignment as well as disposition responsibilities within the workflow. Function as key subject matter expert within Operational Labeling and liaise primarily with Regulatory Affairs Packaging Engineering and Manufacturing. Ensure tasks are completed according to Right FirstTime principles. Collaborate closely with Proofreading and Artwork Development in support of development of label designs and verification of developed label copy against the source documents.

Responsibilities

• Lead coordination within artwork production in artwork management system to ensure on time completion
• Complete redlining tech doc and disposition tasks in the artwork management system
• Drive exception management for artwork workflow execution. Act as primary contact for stakeholders during artwork development proofreading and approval to resolve any issues coordinate recycles and provide support where needed to unsure workflow schedule is maintained
• Complete Change Plan tasks
• Understand performance within their area of responsibility and identify and implement continuous improvement opportunities
• Manage the labeling development and implementation schedule to meet established timelines and negotiate exceptions to planned delivery dates
• Act as owner for specific labeling business processes and assume role of documentation subject matter expert
• Key liaison and subject matter expert for packaging and labeling at AbbVie plants and ThirdParty Manufacturers
• Own coordination of regulatory submission required commodity samples
• For US market only; manage drug listing printed supply notification and commodity specifications

Qualifications :

Qualifications

• Bachelors Degree in Business / Engineering/Sciences preferred. Equivalent successful industry experience (minimum 4 years) can be considered
• Preferred: Labeling experience in Pharmaceutical or Biotech industry. Minimum of 4 6 years combined experience from the following areas: Quality/Regulatory Operations Pharmaceutical/Device Regulations.
• Proficient in English language
• Understands Regulatory Quality and Supply Chain aspects of labeling and impact of noncompliance.
• Demonstrate ability to work in a highly cross functional and global environment
• Ability to motivate and influence others over whom they have no direct authority.
• Knowledge of applicable regulations and standards affecting Pharmaceutical Device Device/Combo Products specifically regulations and standards affecting the Packaging and Labeling Quality System.
• Selfmotivated and strong focus on details and accuracy
• Strong written and interpersonal communication skills
• High affinity to IT systems

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.

• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.

• This job is eligible to participate in our shortterm incentive programs. 

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion.  It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.

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