Let’s do this. Let’s change the world. In this vital role you will discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.
What you will do
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
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.
Basic Qualifications:
Master’s degree and 1 to 3 years of relevant experience OR
Bachelor’s degree and 3 to 5 years of relevant experience OR
Diploma and 7 to 9 years of relevant experience
Preferred Qualifications:
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
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
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com