Amgen is at the forefront of biotechnology, dedicated to developing innovative therapies that transform lives. With a collaborative and inclusive culture, Amgen fosters an environment where individuals can thrive professionally and personally. By joining Amgen, you become part of a mission-driven team working to change the world of healthcare.
Responsibilities in the Job
As an Associate GRAAS Operations, you will be responsible for ensuring technical compliance and smooth execution of Clinical Trial submissions in the EU. Your core responsibilities include:
- Managing Clinical Trial Submissions:
- Oversee Clinical Trial Application approvals throughout the study lifecycle.
- Act as a technical expert in the EMA Clinical Trial Information System (CTIS).
- Collaborating Across Teams:
- Work closely with the EU Regulatory Lead to prepare Submission Content Plans and documentation.
- Coordinate the Requests for Information (RFI) process from review to submission.
- Quality Control:
- Perform QC of data and documents before CTIS upload.
- Ensure timely and accurate archiving of data into internal systems.
- Process Development:
- Assist in defining and implementing processes to meet evolving CTIS needs.
- Proactively resolve issues impacting submission timelines.
Qualifications
Amgen values individuals with diverse experiences and unique perspectives. For this role, the qualifications include:
Basic Qualifications:
- Bachelor’s Degree with 0–3 years of relevant experience, OR
- Diploma with 4–7 years of related experience.
Preferred Qualifications:
- Hands-on experience with Veeva Vault.
- Knowledge of global regulatory processes and standards.
- Ability to learn new software, regulations, and processes quickly.
- Strong organizational and problem-solving skills.
Skills Required
To excel in this role, you should possess:
- Technical Expertise: Proficiency with CTIS and familiarity with EU Clinical Trials Regulation (EU CTR).
- Attention to Detail: Strong QC capabilities for document and data review.
- Collaboration: Excellent teamwork and cross-functional coordination skills.
- Problem-Solving: A proactive, innovative mindset to tackle challenges.
