Project Specialist (Regulatory Affairs)

The Project Specialist will provide project level and support to the Project Lead (PL) or Technical Lead (TL) and team members of assigned projects during any and all phases of the project (planning, initiation, steady state and close out).

Key Accountabilities:

Project Initiation Management Ensures tools are set-up according to SOPs and work instructions (for example, Project Management Plan, SOP list, TIME task codes list, Team list, Project View) Setup of Project Specific Training in LMS Works with PL to create an initial schedule and resource plan in Project View Assists with drafting a consistent and coherent project management plan, including coordinated planning of the different project activities and input from the different functions Project Execution and Control Management Responsible for reporting and analysis and for highlighting issues for project team Maintains the project schedule and resource changes with input from Project Lead Prepares portions of the monthly management and dashboard reports Updates and maintains project tracking databases, compiles data for reports, and other project-related materials Organizes incoming and outgoing correspondence for project management May be responsible for managing project document storage Responsible for updating the project plan as needed and collaborating with the PL/TL to execute the plan. Project Meetings Supports preparation of required information for various project meetings. Support tracking and follow-up of action items. Distributes agendas prior to meetings, and prepares and distribute minutes of internal and client meetings. Project Financial Management Responsible for collating monthly project financial metrics. Reviewing TIME reports against allocated/budgeted time. Reviewing and processing pass through cost invoices. Interacts with Independent Consultants to collect timesheets and processes invoices for payment. Project Closure Management Collaborates with PL/PM/TL on ensuring that documents are archived and final work handed over to the sponsor Closes all project systems and interfaces upon project end. QualificationsIdeal candidate will possess: Initial years of experience in a similar role within life science industry. Fluent English and Romanian. Bachelor’s degree in a science-related field, with an advanced degree desirable PMP or equivalent desirable