Department: Not specified
Location: Not specified
Amgen leverages the power of biology and technology to address the world’s toughest diseases, making lives easier, fuller, and longer. As a pioneer in biotechnology for over 40 years, Amgen continues to innovate using cutting-edge technology and human genetic data. Our mission is to discover, develop, manufacture, and deliver groundbreaking medicines that help millions of patients globally.
In this vital role, you will be responsible for leading the preparation of clinical regulatory documents for public disclosure, ensuring that personal data is anonymized and commercially confidential information is redacted in compliance with applicable regulations, guidance, and company requirements. You will work closely with cross-functional teams to define redaction strategies, lead review processes, and ensure the timely submission or posting of documents. Additionally, you will support continuous improvement initiatives and manage projects to meet deadlines.
Lead Preparation of Regulatory Documents for Public Disclosure:
Manage the preparation of clinical regulatory documents for public disclosure, including anonymizing personal data and redacting commercially confidential information, adhering to relevant regulations and best practices.
Collaboration with Cross-Functional Teams:
Work closely with the transparency team and stakeholders to define redaction strategies, implement redactions, and lead the review and approval processes for submission readiness.
Ensure Timely Submission:
Oversee the submission process, ensuring documents are ready for timely submission or posting as required by regulatory bodies or other authorities.
Trend Analysis & Continuous Improvement:
Support trend analysis and contribute to continuous improvement initiatives related to the clinical transparency and disclosure processes.
Project Management:
Manage projects, coordinate staff, and prioritize work to meet internal and external deadlines, ensuring effective delivery of clinical transparency tasks.
We are looking for a self-motivated, organized, and detail-oriented individual with strong leadership skills, capable of managing multiple tasks and projects while adhering to deadlines. The ideal candidate will have:
Educational Qualifications:
Experience:
Skills & Abilities:
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We ensure that individuals with disabilities are provided with reasonable accommodations to participate in the job application or interview process, perform essential job functions, and receive other benefits of employment. Please contact us to request an accommodation.
To apply, visit careers.amgen.com
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Siliguri |Illinois :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Tallinn |Hà Nội :
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Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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