Senior Manager, Global Compliance and Strategic Initiatives

il y a 4 semaines


VélizyVillacoublay, Île-de-France Dassault Systèmes Temps plein

About Our Organization:

Dassault Systèmes: Innovating for a Sustainable Future

About the Team:

Become a vital part of Dassault Systèmes as we strive to revolutionize the management of clinical trials through cutting-edge technological advancements. We are in search of a committed expert to lead quality assurance and regulatory strategy within the Japanese market. As an essential contributor reporting to the Director of Global Compliance and Strategy for the APAC region, your responsibilities will include:

  • Engaging with local regulatory bodies to advocate for the interests of Dassault Systèmes.
  • Collaborating with clients on quality and regulatory matters pertaining to the application of technology in clinical trials.
  • Working across various departments to fulfill organizational objectives and long-term vision.
  • Contributing to the Unified Protection Strategy in partnership with multiple teams.
  • Assisting in the daily operations of the Global Compliance and Strategy division.
  • Providing operational support for a range of programs managed by the Global Compliance and Strategy team.

Key Responsibilities:

  • Comprehension of regulations governing clinical trials and data management practices.
  • Experience with clinical trial methodologies and technologies, including trial master files and electronic Trial Master Files (eTMF).
  • Familiarity with quality systems processes and their implementation.
  • Proficiency in Japanese at a native level and fluency in English.

Qualifications:

  • A bachelor's degree is required, along with substantial experience in the life sciences sector.
  • A solid grasp of regulations related to clinical trials.
  • Experience as a compliance subject matter expert with the capability to present findings to senior leadership.
  • Willingness to travel as necessary.

Join Dassault Systèmes and benefit from a comprehensive rewards package, which includes competitive benefits and performance bonuses. We are dedicated to supporting our employees in every aspect of their professional and personal lives.

We welcome applications for this position.



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