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.
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