Job Details

ID #53572403
Estado Massachusetts
Ciudad Waltham
Tipo de trabajo Full-time
Salario USD TBD TBD
Fuente Deciphera Pharmaceuticals
Showed 2025-03-04
Fecha 2025-03-04
Fecha tope 2025-05-03
Categoría Etcétera
Crear un currículum vítae
Aplica ya

Senior Specialist, Clinical Trial Transparency and Disclosure (CTD)

Massachusetts, Waltham, 02451 Waltham USA
Aplica ya

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.

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