Senior Specialist, Clinical Trial Transparency and Disclosure - Remote

Overview

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.

In Short

• 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.

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.

Benefits

• Competitive salary and annual bonus.
• Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.
• Generous parental leave and family planning benefits.
• Outstanding culture and opportunities for personal and professional growth.