Clinical Transparency & Disclosure Sr. Associate
Location: Hyderabad, India
Job ID: R-205348
Department: Global Regulatory Affairs & Strategy (GRAAS)
Work Location: On-Site
Category: Clinical
Hiring Manager: Jennifer Vande Weghe
About Amgen
Amgen is a global biotechnology leader dedicated to harnessing the power of biology and technology to combat the world’s most challenging diseases. With over 40 years of innovation, we develop, manufacture, and deliver life-changing medicines to millions of patients. Our commitment to scientific excellence drives us to push the boundaries of what’s possible in healthcare.
Role Overview
As a Clinical Transparency & Disclosure Sr. Associate, you will be responsible for preparing clinical regulatory documents for public disclosure. This includes anonymizing personal data, redacting commercially confidential information, and ensuring compliance with regulatory guidelines. You will work closely with cross-functional teams to maintain quality standards and meet submission timelines.
Key Responsibilities
Prepare clinical regulatory documents for public disclosure, ensuring compliance with regulatory requirements and internal strategies.
Anonymize personal data and redact commercially confidential information as per industry standards.
Ensure document quality, submission readiness, and timely handover for posting or regulatory submission.
Collaborate with cross-functional teams to address challenges and escalate issues when necessary.
Maintain written redaction strategies for specific studies and products.
Manage timelines and coordinate tasks across the team.
Required Skills & Qualifications
Basic Qualifications
Bachelor’s degree in a relevant field.
At least 1 year of experience working with regulatory documents in a biotech or pharmaceutical environment.
Familiarity with clinical research and regulatory documentation.
Knowledge of clinical trial disclosure regulations, guidelines, and industry best practices.
Preferred Qualifications
One year of experience preparing regulatory documents for public disclosure.
Key Competencies
Strong analytical skills with the ability to interpret and apply regulatory data.
Self-motivated with excellent attention to detail and ability to multitask.
Ability to follow structured processes and regulatory guidelines.
Proficiency in spoken and written English.
Strong project management skills, including the ability to prioritize tasks and meet deadlines.
Effective problem-solving and collaboration abilities.
Equal Opportunity Statement
Amgen is an Equal Opportunity Employer committed to fostering an inclusive and diverse workplace. We welcome applicants regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.
If you require accommodations to participate in the application or interview process, perform essential job functions, or access employment benefits, please contact us for support.
Ready to make a difference? Apply now!
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Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
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