Clinical Trials Disclosure Senior Associate

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.

 
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 

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.