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Global Clinical Trial Disclosure Strategist
hace 2 meses
About the Role
We are seeking a highly skilled Global Clinical Trial Disclosure Strategist to join our team at Bayer. As a key member of our organization, you will play a crucial role in 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.
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 the cross-functional internal requirements and the 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 to the 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 2-3 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 to 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.
Estimated Salary
$85,000 - $115,000 per year, depending on qualifications and experience.
About Us
Bayer is a leading global healthcare company that has been improving people's lives for over 150 years. We are committed to innovation, sustainability, and diversity and inclusion. If you're looking for a challenging and rewarding career in a dynamic and growing company, we encourage you to apply.
