Clinical Trials Disclosure Mgr

Career Category

Regulatory

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.

Roles & Responsibilities:

• 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, guidance, and company requirements
• Work closely with the transparency and disclosure team and with cross functional stakeholders to define redaction strategy, to ensure timely and accurate registration and results review/approval process, including the redaction process, for US and EU registries, lead cross functional 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

Required Skills:

• Experience understanding and interpreting data/information and its practical application
• Working experience with redaction/anonymization of clinical trial documents e.g. for EU CTR, HC-PRCI
• Working experience with disclosures on public registries e.g. ClinicalTrials.gov
• 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
• Serve as Process Administer for CTRS, support active CTRS users, system access, inquiries, and issue resolution 

Basic Qualifications:

• Graduate degree and 2 years of relevant work experience in the pharmaceutical industry

OR

• Bachelor’s degree, and 4 years relevant work experience in the pharmaceutical industry
• Minimum of 2 years experience in preparation of regulatory documents for public disclosure
• Familiarity with international regulations, guidance and best practices on clinical transparency & disclosure, including protection of personal information and commercially confidential information

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.

.