Clinical Trial Disclosure Specialist

hace 1 semana

Barcelona, Barcelona, España Bayer A tiempo completo

About Bayer

At Bayer, we're driven to solve the world's toughest challenges and strive for a world where health for all and hunger for none is no longer a dream, but a real possibility.

Job Summary

We're seeking a highly skilled Clinical Trial Disclosure Specialist to join our team. As a key member of our Global Development Management team, you will be responsible for managing and publicly disclosing clinical trial information into clinical trial registries and posting of clinical trial result summaries on company-owned and public international websites.

Key Responsibilities

  • Manage and publicly disclose clinical trial information into clinical trial registries and posting of clinical trial result summaries on company-owned and public international websites based on internal rules and external guidelines, obligations, and legislations for the entire Bayer product portfolio.
  • Analyze cross-functional internal requirements and rapidly changing external legal and regulatory requirements, industry commitments, and obligations to further develop and continuously update Bayer's disclosure strategy for clinical trial information.
  • Disclose information on Bayer's Clinical Trials at high-level quality by fully complying with related Quality Assurance processes.
  • Contribute to further development and implementation of related Quality Assurance processes.

Requirements

  • Advanced degree in Medicine, Life Sciences, or Natural Sciences or equivalent long-term professional experience.
  • Minimum years of experience in clinical trial disclosure with significant experience related to the conduct and analysis of clinical trials.
  • Advanced understanding of global legislations, regulations, and guidelines; strong ability to understand and comply with complex legislations and regulations.
  • Advanced understanding of ICH/GCP regulations.
  • Advanced understanding of drug development process over different stages.
  • Advanced understanding of IT processes and Systems used in Clinical Development, especially Clinical Trial Management Systems, Document and Workflow Management Systems.
  • Strong skills in English language, both oral and written (fluent speaking mandatory).
  • Advanced knowledge of the Bayer product and development portfolio.
  • Solid understanding of cross-divisional business requirements of R&D functions and other internal customers.
  • Advanced written and oral communication skills; advanced understanding of Bayer's general communication policy to the public, to Health Authorities, and to Regulatory Bodies.
  • Advanced project management and project leadership skills.
  • Good ability to manage resources smartly and to do things simply and effectively.
  • Good ability to think and act with customers in mind.
  • Good ability to overcome complexity and to provide oversight.

What We Offer

Bayer offers a dynamic and challenging work environment with opportunities for professional growth and development. We are committed to diversity and inclusion and strive to create a workplace that is welcoming and inclusive for all employees.

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