Job Title: Clinical Trials Disclosure Associate
Location: Hyderabad, India
Employer: Amgen
Work Location Type: On-Site
Date Posted: February 24, 2025
Category: Clinical
About Amgen:
Amgen is a global biotechnology leader that pioneers cutting-edge treatments to tackle the world’s toughest diseases. For over 40 years, Amgen has focused on leveraging human genetic data and technology to create innovative medicines. With a rich history in biopharmaceutical advancements, Amgen is committed to improving the lives of patients worldwide.
Position Overview:
Amgen is hiring a Clinical Transparency & Disclosure Senior Associate to support the preparation and public disclosure of clinical regulatory documents. This position ensures regulatory documents comply with disclosure requirements, including anonymizing personal data and redacting commercially confidential information. The successful candidate will collaborate across teams to ensure high-quality, timely submissions and postings.
Key Responsibilities:
Document Preparation & Redaction: Prepare clinical regulatory documents for public disclosure, ensuring compliance with regulatory requirements by anonymizing personal data and redacting confidential information.
Collaborate & Resolve Issues: Work closely with team members to resolve problems and escalate issues where necessary.
Maintain Strategies: Develop and maintain redaction strategies for studies and products to ensure transparency.
Project Management: Manage timelines and coordinate tasks within the team to meet deadlines and ensure submission readiness.
Ensure Quality: Guarantee consistent quality across all documents and ensure that they are ready for timely submission or posting.
Required Skills:
Data Interpretation: Ability to understand and interpret regulatory data and information.
Multi-tasking & Attention to Detail: Strong ability to handle multiple tasks, with a keen eye for detail and follow-through.
Controlled Processes: Ability to follow defined processes for document preparation and submission.
Communication Skills: Excellent spoken and written English for clear communication.
Project Management: Strong organizational skills with the ability to prioritize tasks and meet deadlines.
Problem-Solving: Ability to solve problems proactively and efficiently.
Basic Qualifications:
Bachelor’s Degree in a related field.
At least 1 year of experience working with regulatory documents in a biotech or pharmaceutical environment.
Familiarity with clinical research and clinical regulatory documents.
Knowledge of clinical trial disclosure regulations, guidelines, and best practices.
Preferred Qualifications:
At least 1 year of experience specifically preparing regulatory documents for public disclosure.
What You Can Expect from Us:
Amgen is an Equal Opportunity Employer and ensures a welcoming work environment for everyone. The company provides reasonable accommodations for individuals with disabilities throughout the application and interview process.
Why Apply?
Joining Amgen as a Clinical Trials Disclosure Associate offers a chance to work with a global leader in biotechnology, driving transparency in clinical trials and contributing to groundbreaking medical advancements. You will be part of an innovative company that values collaboration, attention to detail, and making a real impact on patient outcomes.
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