Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
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
· 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
· 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