Discover a career that empowers you to make a difference in the lives of millions by joining Amgen, a pioneer in the biotechnology industry. With over four decades of innovation, Amgen has transformed healthcare through groundbreaking advancements in human genetic data and technology. This is your opportunity to be part of a world-class team committed to improving lives.
About Amgen: Pioneers in Biotechnology
Amgen was instrumental in establishing the biotechnology industry and continues to lead with cutting-edge solutions. With a focus on discovering, developing, manufacturing, and delivering innovative medicines, Amgen’s commitment is to serve patients worldwide. The company values innovation, collaboration, and the pursuit of excellence, ensuring that every team member plays a vital role in changing the future of healthcare.
Responsibilities as a Clinical Trials Disclosure Senior Associate
As a Clinical Trials Disclosure Senior Associate, you will:
- Prepare Clinical Regulatory Documents:
- Ensure proper anonymization of personal data and redact confidential information in compliance with regulations.
- Coordinate Disclosure Processes:
- Collaborate with cross-functional teams to define redaction strategies, review and approve documents, and ensure timely submissions.
- Maintain Quality Standards:
- Ensure consistent document quality and readiness for submission or public posting.
- Problem-Solving and Communication:
- Work with stakeholders to address issues and escalate problems when necessary.
- Support Process Improvements:
- Participate in trend analysis and implement enhancements to the disclosure process.
Qualifications Required
Basic Qualifications:
- Master’s Degree: 1 to 3 years of relevant experience.
- Bachelor’s Degree: 3 to 5 years of relevant experience.
- Diploma: 7 to 9 years of relevant experience.
Preferred Qualifications:
- Expertise in preparing regulatory documents for public disclosure.
- Familiarity with clinical research and regulatory guidelines.
- Knowledge of clinical trial disclosure regulations and best practices.
- Strong analytical skills for interpreting data and applying it effectively.
Skills That Make You Stand Out
- Self-motivation and excellent multi-tasking abilities.
- Attention to detail and strong follow-through.
- Proficiency in controlled processes and regulations.
- Exceptional spoken and written English.
- Ability to influence, negotiate, and solve complex problems.
- Project management expertise to prioritize tasks and meet deadlines.
