Develops or contributes to the development of the organization's products once human trials begin. Participates in international product teams to define and implement development policy and programs that best support the product strategy and future positioning of the organization.
Purpose:
• Operational public disclosure of 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, including regular updates and maintenance of the disclosed information according to internal and external requirements.
• Contribute to the development and continuous update of Bayer's disclosure processes for clinical trial information based on cross functional internal requirements and the rapidly changing external legal and regulatory requirements, industry commitments and obligations.
• Disclose information on Bayer's Clinical Trials at high level quality by fully complying to the related Quality Assurance processes
Key tasks:
• Manage the public disclosure of clinical trial information, ensuring timely and accurate posting of trial summaries on international and company websites in accordance with internal rules, external guidelines, and general legislation.
• Provide up to date and consistent Clinical Trial Posting data on required company owned and public websites.
• Formal quality control of publicly disclosed clinical trial information according to the QA process established.
• Contribute to the ongoing development and optimization of Bayer’s disclosure processes, adapting to evolving legal,regulatory, and industry requirements.
• Position holder directly interacts with study and product teams, Nuclei, SM teams, RegAff and other CD&O; / MA / PV and CH managers and teams.