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Clinical Transparency Associate
2 weeks ago
Leverage your expertise to lead the development and preparation of documents for public disclosures according to systems and processes, ensuring global transparency regulations and requirements are followed. This role will collaborate with cross-functional teams across multiple geographies and phases of drug development to ensure accurate and timely disclosure of clinical trial information.
Key Responsibilities:
- Document Preparation, Development and Finalization/Document Management
- Clinical Transparency and Disclosure Environment Expertise: Clinical Trial Registration on , Trial Results Posting on , EUDRA.CT/EU CTIS; Plain Language Summaries of Study Results; Document Redaction, including Health Canada and EMA Policy 70 Transparency Submissions
- Effective Project Initiation/Kickoff Meeting to Ensure Product/Study Team Alignment and Understanding
- Presentation of Information in a Clear, Complete, Accurate, and Concise Manner
- Quality Checks for Accuracy and Coordination of Expert/Scientific Reviews
- Negotiation of Timelines and Content with Team Members
Required Skills and Qualifications
- Bachelor's Degree in a Scientific, Health, or Communications Related Field or, Bachelor's Degree in Any Field with at Least Two Years of Experience in Transparency
- High-Level End-User Computer Skills (Adobe, MS Office Applications, Word, Excel, PowerPoint)
- Mastery of English Language Skills, Written and Spoken
Benefits and Preferences
- Experience with Transparency Processes (CT Registry, Redaction, Plain Language Summary), Including Knowledge of Regulations, Guidelines, and Standards
- Understanding of Biostatistics and Clinical Study Designs
- Verbal Reasoning, Attention to Detail, Critical Thinking, and Analytical Ability
- Demonstrated Project Management and Time Management Skills
- Ability to Deal with Ambiguity and Plan, Prioritize, and Manage Conflicting Priorities
Seniorities and Employment
- Seniority Level: Entry Level
- Employment Type: Full-Time
- Job Function: Research, Analyst, and Information Technology
- Industries: Pharmaceutical Manufacturing
