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Senior Manager, Global Compliance and Strategic Initiatives
Il y a 3 mois
About Dassault Systèmes:
Transforming Industries and Enriching Lives
About the Team:
Join our dedicated team at Dassault Systèmes, where we are committed to revolutionizing the landscape of clinical trials through cutting-edge technological innovations. We are in search of a passionate professional to concentrate on quality assurance and regulatory strategy within the Japanese market. As an integral member of our team, reporting directly to the Director of Global Compliance and Strategy for the APAC region, your role will encompass:
- Engaging with local regulatory bodies to advocate for the interests of Dassault Systèmes.
- Collaborating with clients on quality and regulatory matters associated with technology applications in clinical trials.
- Working collaboratively across various teams to fulfill corporate objectives and long-term strategic vision.
- Contributing to the Unified Protection Strategy in partnership with multiple departments.
- Assisting with daily operations within the Global Compliance and Strategy division.
- Providing operational support for diverse programs managed by the Global Compliance and Strategy team.
Key Responsibilities:
- Comprehension of regulations governing clinical trials and data management.
- 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.
Required Qualifications:
- A Bachelor's degree is essential, accompanied by substantial experience in the life sciences sector.
- A robust understanding of the regulations governing clinical trials.
- Experience as a compliance expert with the capability to present insights to executive leadership.
- Willingness to travel as necessary.
At Dassault Systèmes, we offer a comprehensive rewards package, inclusive of benefits and bonuses. We are dedicated to supporting our employees in every facet of their professional and personal lives.
We look forward to receiving your application for this position.