Clinical Trials Disclosure Senior Associate

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.

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