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Amgen
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.
Let’s do this. Let’s change the world. In this vital role, you will lead the preparation of clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with applicable regulations, guidances, and company requirements.
Work closely with the transparency team and crossfunctional stakeholders to define redaction strategy, implement redactions, lead crossfunctional review and approval, ensure submission readiness, and hand off for timely submission or posting
Support trend analysis and continuous improvement initiatives
Manage projects, coordinate the work of other staff, and prioritize work in order to meet internal and external deadlines
Master’s degree and 4 to 6 years of pharmaceutical industry experience OR
Bachelor’s degree and 6 to 8 years of pharmaceutical industry experience OR
Diploma and 10 to 12 years of pharmaceutical industry experience
Minimum of 2 years experience in preparation of regulatory documents for public disclosure
Familiarity with international regulations, guidances and best practices on clinical transparency & disclosure, including protection of personal information and commercially confidential information
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
Good communication skills including excellent spoken and written English
Ability to follow controlled processes
Leadership skills, including ability to teach, 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.
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