Full-Time Senior Clinical Trial Specialist

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.

1. Oversee end-to-end processes for transparency/disclosure deliverables.
2. Ensure compliance with global regulations (EU CTIS, EMA Policy 0070, Health Canada PRCI, ClinicalTrials.gov).
3. Coordinate CTD strategy and project manage deliverables.
4. Educate company-wide on CTD procedures and industry trends.
5. Develop CTD work instructions and user guides.
6. Provide oversight of quality and vendor/CRO deliverables.
7. Assist in operational support of GMW & CTD.
8. Lead cross-functional teams in maintaining Company Confidential Information (CCI) and Protected Personal Data (PPD).
9. Measure and communicate internal compliance and performance metrics.

Requirements:

• Bachelor's Degree in pharmacy, biology, chemistry, medicine, or equivalent required; Master's of Science Degree preferred.
• 3+ years of experience in the pharmaceutical industry and clinical trial transparency/disclosure.
• Working knowledge of global laws, regulations, and guidelines related to clinical trial documents and data disclosure.
• Experience with plain language summaries, CCI redaction, PPD anonymization, and registration/results postings on ClinicalTrials.gov and EU CTIS.
• Excellent organizational, communication, time, problem-solving, and project management skills.
• Proficient with Microsoft Office products, Smart Sheet, Please Review, Veeva Vault, and Adobe Suite.

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