Top 3 Must Have Skill Sets:
- Excellent understanding of project management processes and procedures (7-10 years experience)
- Proficient MS Project, MS Word, Visio, MS PowerPoint and MS Excel skills, Smart Sheets
- Expertise in business process development best practices and change management (process mapping, full cycle project/change management)
- Knowledge of global regulations and guidance’s for biologics and combination products (e.g. GCP, GMP, GVP, GDP, ICH)
- Provide planning, analysis, and execution of assessments/document revisions (execution of regulation assessments and document revisions)
- Strong communication skills to work with cross-program resources.
Day to Day Responsibilities:
- The primary focus will be working with Operations and Research & Development (R&D) Functional Area working team working to harmonize key quality management systems under the guidance and direction of the Work stream Lead. The initiative scope is broad and requires interaction with multiple cross-functional stakeholders in varies functions across Operations and R&D.
- Manage and maintain project documentation to support resource allocation and all phases of development life cycle (i.e. feasibility study, requirements, analysis, ROI, business plan, design, testing, and implementation planning).
- Ensures all project requirements and/or objectives are documented.
- Monitor critical time bound tasks
- Provide planning, analysis, and execution of assessments/document revisions
- Support/create project planning of each sub workstream as required.
- Identify and implement execution risk mitigation activities as required
- Coordinate and engage the associated functional cross-functional stakeholders and impacted populations with change management activities and communication
- Job Details: Manages one or more high-level, complex non-technical projects within the constraints of scope, quality, time, and cost, to deliver specified requirements. Projects may be strategic in nature. Responsibilities may include resource allocation and all phases of development life cycle (i.e. feasibility study, requirements, analysis, ROI, business plan, design, testing, and implementation planning). Regularly interacts with management. Coordinates and directs the activities of project team members. May be responsible for cross-functional teams. Ensures all project requirements and/or objectives are documented. May obtain and manage external resources required for project completion.; Skills: ; expertise in running medium to large scale projects ; excellent understanding of project management processes and procedures ; experience with project management and analyst methodologies and best practices ; strong analytical skills ; business process development best practices, change management ; strong MS Project, MS Word, Visio, MS PowerPoint and MS Excel skills ; understanding of systems for sharing and collaboration ; excellent communication skills to work with cross-program resources