Job Description

Associate Director, Business System Labeling Management

Required experience and skills:

• Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement experience strongly preferred, and experience with IT System/Business System Management.

Education Min. Requirement:

BS/BA or an equivalent certification/experience in science, engineering, IT or related discipline with functional working experience in System Development/Management within Manufacturing or Research areas preferred.

Start date: As soon as possible.

Job Description:

Seeking a full-time Business System Associate for the Labeling Operations area within the GRACS Regulatory Innovation & Information Management organization.

Primary area of responsibilities will include:

• Project support for System Development, Maintenance, Enhancement and System Monitoring related initiatives.

• Serve as a liaison between the Global Labeling Business Users of the Systems and the associated IT Partners for defining Business Requirements and ensuring the system is aligned to meet the business needs.

• Facilitate System Operations Mtgs including discussions to resolve issues and manage competing priorities utilizing proper escalation pathways to ensure limited impact to delivery timelines for workstream activities.

• Support the development of User facing System Resources ensuring supporting materials remain aligned with the current system version. Work collaboratively with stakeholders in Global Labeling, System Support Team, IT and Learning & Development organizations to meet required delivery timelines associated with User Resources.

• Support System Releases in collaboration with IT Business Partners including activities relating to Requirements Gathering, Documentation, Testing, Implementation, Deployment and Hypercare phases.

• Facilitate and oversee the System Support Model for systems within remit including:

  • Monitor user support cases, ensuring proper investigation are conducted, CAPAs detailed and closed effectively and communication is consistently done to reduce instances of recurrence.

  • Identify and design improvement opportunities within the Support Model to reduce compliance risk and increase efficiency for the Support Team and End Users.

• Conduct System Administrator activities supporting the alignment of the Global organizational processes with the System Capability cross-functionally and cross-regionally.

• Provide support and facilitation, as applicable, for the System Specific Global User Group Forums, Release/System Communication authoring and Program Updates, as requested.

Preferred Experience and Skills:

• Candidate must be familiar with IT system and business process support, preferably in the Regulatory or Labeling Management space with general understanding of Label Update process.

• Analytical and process minded with a short learning curve for systems and processes to drive results based on specified objectives.

• Demonstrates strong leadership and problem-solving skills and ability to gather relevant facts and distill information. 

• Effortlessly works in a collaborative manner with cross-functional and cross-regional users and stakeholders while building strong working relationships.

• Effective communication skills (verbal and written).

• Ability to work cooperatively with others and provides significant contributions as a member of a team in addition to serving in a leadership capacity.

• Strong organizational skills. 

• The ability to be flexible and handle multiple tasks well, under pressure.

• Demonstrates strong attention to detail.

• Process-oriented with familiarity of GMP requirements and working in a highly regulated industry.

• Experience with business process mapping and system design for workflow management is an asset.

• Strong aptitude for authoring Technical Guidance documentation such as User Guidance and Standard Operating Procedures (SOP) and change control management is desirable.

• Good understanding of SDLC Documentation requirements and processes pertaining to system management for GxP/GMP applications.

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