Amgen, a global leader in biotechnology, is expanding its team in Hyderabad, India, and is currently hiring for multiple roles, including Associate Data Management, Associate – Clinical Trial Submission Management, and Data Engineer. If you are passionate about making a difference in the biotech industry and have the skills to contribute to groundbreaking work, this is your opportunity to join a company dedicated to serving patients worldwide.
Below, we’ve outlined the details of each role, including responsibilities, qualifications, and how to apply.
1. Associate Data Management
Location: Hyderabad, India
Job Type: On-Site, Full-Time
Job Requisition ID: R-206616
Career Category: Operations
Job Description
As an Associate, Regulatory Data Management, you will play a critical role in ensuring the compliance and smooth flow of regulatory data across systems and processes.
Roles & Responsibilities
- Maintain the Regulatory Information Management (RIM) system.
- Create and archive clinical trial submissions, marketing applications, and health authority correspondence.
- Act as a liaison between regulatory representatives, CMC, safety teams, and submission management teams.
- Support data streamline projects by creating, running, and analyzing reports.
- Assist with US and EU Certificate of Pharmaceutical Product (CPP/CMP) processes during peak workloads.
- Adhere to Amgen’s processes, policies, and SOPs.
Required Knowledge and Skills
- Familiarity with regulatory procedures and filings.
- Knowledge of global health authority requirements (FDA, EMA, MHRA).
- Strong organizational and detail-oriented skills.
Preferred Knowledge and Skills
- Experience with the Veeva Vault platform.
- Knowledge of regulatory data standards like IDMP.
Education and Experience
- Master’s degree with some related experience OR
- Bachelor’s degree and 2 years of experience OR
- Associate’s degree and 4 years of experience OR
- High school diploma/GED and 5+ years of experience.
2. Associate – Clinical Trial Submission Management
Location: Hyderabad, India
Job Type: On-Site, Full-Time
Job Requisition ID: R-206610
Career Category: Safety
Job Description
In this role, you will ensure the technical compliance of Clinical Trial submissions by managing the flow of information between functional areas, local offices, and regulatory authorities.
Roles & Responsibilities
- Ensure compliance with the EU Clinical Trials Regulation (EU CTR) for Clinical Trial submissions.
- Prepare Submission Content Plans and documentation.
- Perform Quality Control (QC) of data and documents before CTIS upload.
- Coordinate the Requests for Information (RFI) process.
- Manage Clinical Trial Notifications through CTIS.
- Assist in developing processes to meet evolving CTIS needs.
Basic Qualifications
- Bachelor’s degree and 0-3 years of experience OR
- Diploma and 4-7 years of experience.
Preferred Qualifications
- Experience with Veeva Vault.
- Familiarity with global regulatory processes.
- Strong problem-solving and organizational skills.
3. Data Engineer
Location: Hyderabad, India
Job Type: On-Site, Full-Time
Job Requisition ID: R-204064
Career Category: Information Systems
Job Description
As a Data Engineer, you will design, develop, and deploy data pipelines for clinical data domains, enabling advanced analytics for clinical trial design and development.
Roles & Responsibilities
- Develop and support AWS, Databricks, and RStudio platforms.
- Build reusable program components using AI, Python, R, and NLP.
- Collaborate with Data Architects and Data Scientists to translate business requirements into technical solutions.
- Manage DevOps for cloud-based systems.
- Explore new tools and technologies to enhance data pipelines.
Basic Qualifications
- Master’s degree and 1-3 years of experience OR
- Bachelor’s degree and 3-5 years of experience OR
- Diploma and 7-9 years of experience.
Must-Have Skills
- Advanced skills in SQL, Python, R, AWS, and Databricks.
- Knowledge of AI/Machine Learning technologies.
- Experience with DevOps CI/CD tools like Git and Jenkins.
Good-to-Have Skills
- Experience in the biotech or pharmaceutical industry.
- Familiarity with Scaled Agile Framework (SAFe).
- Knowledge of clinical trial data standards and structures.
Certifications
- SAFe for Teams certification (preferred).
Why Join Amgen?
Amgen offers a collaborative, innovative, and science-driven culture. In addition to competitive salaries, Amgen provides comprehensive Total Rewards Plans aligned with local industry standards.
How to Apply
If you’re ready to take the next step in your career, apply now for these exciting opportunities at Amgen:
- Associate Data Management: Apply Here
- Associate – Clinical Trial Submission Management: Apply Here
- Data Engineer: Apply Here
