ABOUT AMGEN
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We 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.
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
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
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
EQUAL OPPORTUNITY STATEMENT
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.