Main responsibilities:

•          Develop the planning of 3 to 4 New Vaccines projects, for both research & development, based on the strategy/tactics discussed by the project team and based on governance decisions.

•          Analyse the project timelines and ensure optimal critical path.

•          Alert the project team on any planning issues and provide guidance on project planning optimization.

•          Based on GPM/ GPT request, develop optimized timelines scenario and provide recommendation

•          Coordinate with GPM to align project and operational planning with the project strategy.

•          Collaborate efficiently with all operational planning actors to ensure consistency between the project plan and the operational plans.

•          Ensure Project level plan is up to date (at least monthly) in RDPM planning system.

•          Monitor the progress, the deviation with their explanations and the associated action plan on a monthly basis.

•          Ensure consistency and high-quality production of planning data by conducting QC of the plan and adjust with relevant planning actors.

Act as Super user in Vx Project planner community:

Manage process, tool and support all users/clients and ensure consistency, robustness and optimization,
Conduct training, education, and refresher sessions as needed for new planners,
Provide feedback on evolution of NV template / metrics updates.
For CTD Development:

•          In cooperation with the Global Regulatory Lead (GRL) members of the Global Regulatory Team and Global Project Manager (GPM), develop a comprehensive table of content listing all documents part of CTD.

•          Develop a schedule for individual document draft, review, and approval, predecessor and successor logic and expected durations with the support of the Global Project Manager and the leaders of CTD satellite teams (e.g. clinical, nonclinical)

•          Verify resource assignments for document preparation (to ensure the schedule is viable) and escalates resource issues to the core CTD Taskforce.

•          Lead tracking efforts through effective schedule management, maintains status update reports for CTD satellite teams, sub-team leads, and CTD task force.

•          Maintain status update reports for CTD satellite teams, sub-team leads, and CTD task force.

•          Escalate resourcing and schedule problems and provide solutions as needed to remove impediments, resolve schedule conflicts, and meet document approval timelines.

•          Provide support to coordinate the preparation of the Health Authorities answers to questions and updated relevant CTD modules if needed and ensure on time delivery of answers / updated CTD modules for submission of answer to questions.

•          Evaluate and assess the document preparation and review results through effective metrics, tracking tools and lessons learned to inform future CTD preparation planning.

About you

Experience:

•          Previous experience in the pharmaceutical industry with understanding of R&D and its project lifecycle,

•          Previous experience project / planning management.

•          Knowledge of drug/ vaccine development & regulatory pathways,

•          Knowledge of CTD structure/ Experience of a major filing,

Soft Skills:

•          Teamwork and transversal collaboration, strong networking skill & customer oriented,

•          Ability to coordinate activities and manage various stakeholders, in a multi-cultural environment,

•          Evaluate and assess the document preparation and review results through effective metrics, tracking tools and lessons learned to inform future CTD preparation planning.

•          Strong communication skills (written and oral),

•          Analytical, data quality driven, synthesis and reporting skills,

•          Evaluate and assess the document preparation and review results through effective metrics, tracking tools and lessons learned to inform future CTD preparation planning.

•          Pragmatism, agility, autonomy, adaptability, curiosity, culture of sharing.

•          Strong negotiation, communication and influencing skills,

•          Conflict resolution experience.

Technical skills: 

•          Knowledge of drug/vaccine development process and in-depth understanding of interconnections between all contributors to the project strategy at all stages of development,

•          Solid project / planning management skills (experiences in Project team),

•          Knowledge of a planning tool,

•          Planisware® technology would be a plus.

Education: 

•          Bachelor-level University Scientific degree or in Planning/Project Management  

Language(s):

Strong English skills (verbal and written), ability to exchange fluently in a global environment
Proficiency in French would be a plus.