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Sr Compliance Specialist I

Pharmaceutical Product Development (PPD)

Mexico City, Mexico

Job Description

As a Senior Compliance Specialist with responsibility for project support in the Quality Risk Management Technology Solutions team, you are responsible for coordinating set-up, maintenance and modification of the team project schedules for delivery of enhancements to the Veeva Quality Suite. The Compliance Specialist works in collaboration with Global Process Owners (GPOs), Subject Matter Experts (SMEs) and operational representatives across the Clinical Research Group (CRGs) operational groups to support enhancements in the Veeva Quality Vault for Veeva Quality Docs (VQD) and Veeva Quality Management Solution (QMS). The Senior Compliance Specialist also consults on project management issues and supports overall function of the Technology Solutions team. This role will also support Change Management activities.

Essential Duties and Responsibilities (other duties may be assigned):

· Manages ongoing projects. Develops new schedules using project management tools and templates as appropriate and in collaboration with functional teams.

· Creates, tracks and updates project plans.

· Compiles project reports and status updates.

· Schedules meetings, prepares and distributes agendas, records and distributes minutes.

· Monitors assigned tasks, adjusts priorities and work schedule to meet deadlines and provide high quality deliverables. Completes additional tasks as needed in support of project, client, and departmental objectives.

· Brings together information from internal project functions to coordinate the execution of project deliverables.

· Manages and coordinates cross-functional gathering of information for project risks (from identification to closure).

· Maintains compliance with all organization policies, standard operating procedures (SOPs), and project specific requirements

Personal Skills & Competencies:

· Basic understanding of project management (time, quality, cost) and change management skills.

· General knowledge of Quality Assurance in a regulated environment

· Good organizational skills. Ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines.

· Ability to be attentive to stakeholder needs. Ability to learn how to manage stakeholders.

· Raises concerns for perceived risks including out of scope.

· Strong attention to detail. Demonstrated experience in identification and resolution of technical problems in a professional environment.

· Demonstrated positive attitude, enthusiasm toward work, and the ability to work well with others.

· Proactive and results oriented, including ability to be attentive to stakeholder needs.

· Ability to effectively use automated systems and computerized applications such as Microsoft Outlook, Excel, Word, PowerPoint, Project, Visio, etc.

· Excellent written and verbal communication skills (English required).

Job posted: 2024-02-21

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