Clinical Trials Disclosure Senior Associate

• Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information
• Work closely with cross-functional stakeholders to define redaction strategy, lead review and approval, ensure submission readiness, and hand off for timely submission or posting
• Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting
• Communicate with team members to resolve problems and escalate issues
• Record and maintain written redaction strategy for the study and product
• Support trend analysis and process improvement

• Masters degree and 1 to 3 years of relevant experience OR
• Bachelors degree and 3 to 5 years of relevant experience OR
• Diploma and 7 to 9 years of relevant experience
• Minimum of 2 years experience in preparing regulatory documents for public disclosure
• Familiarity with clinical research and clinical regulatory documents
• Knowledge of clinical trial disclosure regulations, guidelines, and best practices

Basic Qualifications:

• Experience understanding and interpreting data/information and its practical application
• Self-motivated with developed skills in multi-tasking, attention to detail, and follow-through
• Ability to follow controlled processes
• Excellent spoken and written English
• Ability to negotiate and influence
• Project management skills, including ability to prioritize work in order to meet required deadlines
• Problem solving ability