Documentation and Compliance L06

Job Description

Functional leadership in CDC by providing tactical planning and oversight of VAULT eTMF and other systems, to include being the liaison with other functional areas. Project Manager of business process efficiencies and improvements related to VAULT eTMF and other systems, to include implementation and user acceptance/knowledge management. SME for all CDC processes, including work instructions. May conduct training and participate in mentoring junior staff.

• Manages day-to-day eTMF system utilization by: -managing the implementation of VAULT eTMF system enhancements across the business -managing initial and ongoing training/coaching on system functionality and processes to all internal and external VAULT eTMF users -works collaboratively with study support colleagues to coordinate audit and inspection readiness activities related to eTMF; -works collaboratively with study support colleagues to ensure quality checks are being conducted on the eTMF
• Project Manager for the planning and execution of eTMF transfers to/from external partners.
• Participates in the review of and assessment of metrics/ dashboards.
• Evaluates and updates work instructions related to department processes.
• Project manages the process of evaluating and updating the artifact maps/Expected Document Lists.
• Complies with GCP, AbbVie SOPs and functional area processes.
• Reports to an Assistant/Associate Director and will have direct reports.

Qualifications

• Bachelor degree or international equivalent is required, degree related to IT/Systems preferred
• With at least 6 years Pharma experience or related professional experience.
• Demonstration of successful coaching/mentoring in a matrix environment.
• Proven communication, organizational, project management and leadership skills.
• Demonstrates problem solving skills
• Competent utilization of electronic systems
• Possesses a high level of core and technical competencies related to development, product, and trial master file maintenance and processes
• Proven successful coaching/mentoring in a matrix environment​

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 long-term 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 Company's sole and absolute discretion unless and until paid and may be modified at the Company’s 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 and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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