job title:clinical trial disclosure associate(amgen)

Roles & Responsibilities:

• Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with regulatory requirements and the agreed strategy defined by the cross functional team

• Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting

• Collaborate with team members to resolve problems and escalate issues

• Record and maintain written redaction strategy for the study and product

• Manage timelines and coordinate work across team

Required Skills:

• 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

• Project management skills, including ability to prioritize work in order to meet required deadlines

• Problem solving ability

Basic Qualifications:

• Bachelor’s degree

• Minimum of 1 year experience working with regulatory documents in a biotech/ pharmaceutical environment

• Familiarity with clinical research and clinical regulatory documents

• Knowledge of clinical trial disclosure regulations, guidelines, and best practices

Preferred Qualifications:

• One year experience preparing regulatory documents for public disclosure