Clinical Trials Disclosure Manager

Career Category Clinical Job Description 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 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 What we expect of you 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. . Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen

Apply Job!