Deciphera is seeking a Senior Specialist in Clinical Trial Transparency and Disclosure (CTD) to join our expanding Global Medical Writing (GMW) & CTD department. This role involves managing transparency/disclosure processes, ensuring compliance, and leading cross-functional teams in developing disclosures for clinical trial programs.Responsibilities:Oversee end-to-end processes for transparency/disclosure deliverables.Ensure compliance with global regulations (EU CTIS, EMA Policy 0070, Health Canada PRCI, ClinicalTrials.gov).Coordinate CTD strategy and project manage deliverables.Educate company-wide on CTD procedures and industry trends.Develop CTD work instructions and user guides.Provide oversight of quality and vendor/CRO deliverables.Assist in operational support of GMW & CTD.Lead cross-functional teams in maintaining Company Confidential Information (CCI) and Protected Personal Data (PPD).Measure and communicate internal compliance and performance metrics.
