Regulatory planner

Description

• Owner of the operational planning of several Pharma & Vaccines projects for all regulatory activities, whatever their location.
• Ensures the project strategy is reflected in terms of Planning into the operational plan. Is accountable for the customization of the operational plan with the most known information.
• Is accountable of a rolling update of the activities under their functional perimeter
• Is an active member of the Monthly Project Planning Review meeting with other Planning actors, sharing news on planning/execution and highlighting potential risks/impacts
• Analyzes the project deliverable timelines and critical path activities.
• Works closely with all Planning actors (CSO, TMU, CMC OPCMs and PPM) for anticipating and identifying any deviation and alerting key OPCM interfaces in case of major events having an impact on project milestones and proposes recommendations / facilitates decision making. 
• Supports impact management by making analyses and assessing planning scenarios with project and planning actors.
• Is active contributor of the Program Financial Valorization exercise for Governance decision by creating appropriate scenarios in the project portfolio management tool.
• Once agreed with Project actors, OPCM is the single accountable person for the accuracy of the plan entered and its customization in the planning tool. He/she ensures history data follow-up in the planning tool and coordinates quality controls of Planning data.
• Communicates the updates to the appropriate stakeholders as well as any report (e.g., Gantt chart) supporting decision management.
• Provides reporting and analysis to support the project team and GRA operational teams, including during project (sub) team meetings.
• Leads, supports, implements and communicate the operational planning standards / templates improvement (Libraries of activities) in the RDPM planning tool as well as the development of the quality checks.
• Participates in any user requirement definition &/or testing for new reports & upgrades of existing ones
• Leads &/or represents OPCM in any initiative aiming at improving, simplifying or automating planning updates & OPCM ways of working, such as process definition & maintenance of processes, planning best practices, etc.
• Represents Regulatory OPCM in Master Data Management (MDM) topics such as in study coding & tool enhancement.

Qualifications

Minimum master in a scientific degree and / or regulatory affairs

• Rigor, Analytical skills and spirit of synthesis, Quality orientation
• Excellent organizational skills, rigor, striving for results, high accuracy orientated
• Strong communication skills and interpersonal relationship demonstrated
• Excellent presentation skills (verbal and written)
• Strong Networking skills
• Creative problem-solving skills

Technical Skills

• Good computers skills
• Knowledge of planning tool (Gantt chart)