InSight Project Manager with GxP
Creative Solutions Services LLC - Cambridge, MA

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our client in cambridge, ma is looking for a IT Project manager with biotech regulatory experience. This is a long term consulting position. Job Summary:
The INSIGHT Project Manager is responsible for the planning and execution of business process improvement and regulatory information management project. The INSIGHT Project Manager will work with business process owners, information technology staff, and subject matter experts to lead business process initiatives or implement enhanced information technology capabilities that support Regulatory Affairs operational and strategic goals. The individual will not necessarily have strategic or operational responsibilities, but will focus on project management responsibilities to ensure that assigned projects are completed on-time and within budget. Responsibilities: ? Leads moderately complex projects from project initiation to implementation. ?
Facilitates the definition of the project mission, goals, milestones, tasks, deliverables and resource requirements. ?
Develops and maintains project plans, status reports, issue logs, and other project related artifacts. ?
Creates strategies for risk mitigation and contingency planning. ?
Effectively communicates project status, issues, schedule and accomplishments to various management and stakeholder groups, as needed. ?
Ensures that assigned projects are conducted in compliance with applicable regulatory, information technology, enterprise, and departmental regulations, guidance, policies, procedures and methodologies. ?
Assists in assembling the project staff and provides assessments and evaluations of team member performance to appropriate people managers. ?
Coaches, motivates, and creates a sense of belonging and ownership among team members. ?
Builds coalitions among the various stakeholders and negotiates authority to move the project forward. ?
Efficiently identifies and resolves project issues. Minimum Educational Requirements: Bachelor?s Degree in Information Technology, Management Information Systems, Business Management or associated field required. Master Degree preferred.
Skills / Knowledge Required: ? 5+ years of experience as a Project Manager ?
Pharmaceutical, Bio-Technology, or Life Science industry experience ?
Experience working in a GxP validation environment ?
Systems Development Life Cycle (Analysis through Implementation) ?
Experience with Regulatory Processes and Systems a plus ?
Experience with Liquent?s InSight software platform or other Submissions Management systems a plus ?
Awareness of Business and Enterprise Architecture ?
Strong Customer and Business Relationship Management skills ?
Project experience with COTS and web application requirements, design, or development