Vaccine R&D Project Planning Manager

• Job title: Vaccine R&D Project Planning Manager


• Location: Budapest, Hungary


• Job type: Permanent, full-time


• Hybrid working
  

About the job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Join our global R&D Resource & Demand Planning team as a Vaccine R&D Project Planning manager and you'll develop and manage the Project level plan in Planning tool of each New Vaccine project (from M0 to License) in ensuring a proactive support to the Global Project Manager and Project team. In addition, you would also be in charge of the Common Technical Document (the timelines, scheduling, coordination, and tracking of all contributing documentation for the CTD submission for First licensures for initial submissions (including Q&A) & major variations under the scope of R&D (US/EU/CN/JP).

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.

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team in an international work environment


• Work from an "Office of the Year 2023" award winner with flexible home office policy


• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact


• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave


• An individual and well-structured introduction and training of new employees and we will dedicate a Buddy for you to better navigate in your first weeks


• Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs)

Pursue Progress . Discover Extraordinary .

Progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let's pursue progress. And let's discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at !

Discover our Code of Conduct , that serves as the moral compass that guides us when chasing the miracles of science to improve people's lives. Please ensure to have read this document before applying.

&D