Reg Cmc Project Planner H/F

Hiring By - Biostaffic



Job Highlights

Not Disclosed

Posted 4 months ago
Job details
Ividata Life Sciences est la filiale du groupe Ividata qui accompagne les industriels de la santé depuis 2013 sur l'ensemble du territoire français autour de problématiques scientifiques, techniques et opérationnelle. Nos collaborateurs et nos experts interviennent sur les métiers des opérations cliniques, la biométrie & data science, la pharmacovigilance, les affaires réglementaires, l'assurance qualité. Notre ambition ? Challenger l'existant, anticiper demain, et accélérer notre développement tout en étant soucieux de maintenir notre niveau de relation de confiance avec nos consultants et nos clients
Nos consultants sont le coeur de notre réussite : nous sommes convaincus que le bien-être de nos équipes est la clé pour garantir le meilleur accompagnement possible auprès de nos clients.
Fort de ses 300 experts, Ividata propose une approche complète intégrant stratégie, conseil, services et technologie. Ses 3 piliers : excellence, innovation & bien-être.
The Regulatory CMC Division of our is looking for a Reg CMC Project Planner.
Activities & Responsibilities
  • Create and maintain effective work planning tools to give CMC Regulatory a short, medium and long term view of planned activities.
  • Support CMC Regulatory Teams in setting up project/product master schedules. Initiate, maintain and follow-up the Project Master Schedule and critical path for the Project. Monitor the upstream status of projects status upstream, highlighting any unresolved major risks and potential overruns to CMC Regulatory Leadership Team. In case of risk of slippage, provides supports with building and monitoring mitigation plans to achieve agreed-upon timelines.
  • Provide the CMC Regulatory Leadership Team with forward visibility of resource gaps to facilitate budget and prioritization discussions.
  • Support the CMC Regulatory organisation to improve departmental planning and forecasting capability by developing tools and processes that fit with our vision of process simplification. Identify continuous improvement opportunities for both planning tools and process. Proactively communicate with stakeholders to improve visibility and plans for CMC regulatory activities. Act as the link with stakeholders, as required, in order to meet established business goals.
  • Develop and deliver training to CMC Regulatory on project planning good practice. Provide support to team on an individual basis to plan the efficient delivery of CMC regulatory projects to support goals and prioritization model.
  • Project management of assigned department projects ensuring that project plans are in place and action items are identified and tracked.
  • Project Planner with 6 - 8 years experience with at least 3 of them in a similar position in the Pharma industry
  • BS/ MS degree in a relevant field or related experience
  • Experience in project planning within the pharmaceutical industry, GMP manufacturing or R&D environment
  • Excellent project planning capability and broad knowledge of planning tools
  • Excellent communication skills, organization and planning skills and attention to detail
  • Must BE able to communicate effectively in the English language
  • Ability to work both independently and under supervision in a timely manner
  • Demonstrates a solution oriented mind set
  • Ability to manage complexity in a range of situations
  • Creativity in problem identification and resolution and a relentless, hands-on drive to implement and accomplish company goals and objectives in a rapid-paced, changing business environment
  • Strong analytical skills and attention to detail
  • Effective communication with ability to influence others at every level (Persuasive) in a highly scientific and technical environment (written and verbal) including diplomacy, negotiation skills
  • Thinks big picture and can connect the dots easily
  • Collaborates well with other areas of the business

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No


  • France

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 18, 2024
Company Overview
Ividata Life Sciences
Ividata Life Sciences

Current Openings: 0

Ividata Life Sciences est un cabinet de conseil dédié aux acteurs de la santé : industrie pharmaceutique, biotechnologies, dispositifs médicaux, cosmétologie… Nos consultants sont experts en Recherche & Développement (R&D) de l’industrie Life Sciences : opérations cliniques, biostatistiques et programmation statistiques, data science, pharmacovigilance, assurance qualité, affaires réglementaires, etc.. Chaque jour, ils accompagnent nos clients sur l’ensemble du cycle de vie du médicament, en oncologie, maladies rares, immunologie, vaccins, contribuent à l’avancée de la recherche médicale en France.
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