Grad Intern - Global Regulatory Affairs Cmc

2+ years

Not Disclosed

Remote, USA

10 Nov. 26, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Join Amgen’s Mission of Serving Patients
At Amgen, our shared mission—to serve patients living with serious illnesses—drives everything we do. Since 1980, we’ve helped pioneer biotechnology in the fight against the world’s toughest diseases. With a focus on Oncology, Inflammation, General Medicine, and Rare Disease, we reach millions of patients each year. Join us and make a lasting impact on the lives of patients while transforming your career.

Grad Intern - Global Regulatory Affairs CMC

What You Will Do
Let’s change the world together! During this program, you will work within the Global Regulatory Affairs Chemistry, Manufacture, and Controls (CMC) organization to support Amgen’s commercial product portfolio. The goal is to collect global regulatory intelligence and help develop processes and tools to efficiently manage post-approval CMC regulatory activities. This internship will provide you with a chance to understand the responsibilities of a CMC regulatory scientist. The specific goals of the internship include:

Collecting regulatory intelligence for post-approval regulatory activities.
Assisting in the development of processes and tools for effective management of post-approval submissions.
Participating in group meetings and ad-hoc assignments to gain an understanding of CMC regulatory responsibilities.

What We Expect of You
The dynamic individual we seek is a Ph.D. candidate with the following qualifications:

Basic Qualifications:

18 years or older.
Graduated with a bachelor’s degree from an accredited college or university.
Currently enrolled in a Ph.D. program (preferably in biochemistry, pharmacology, organic chemistry, pharmaceutical science, or a related field) and completed at least one year of your graduate program by the internship start date.
Enrolled in an accredited college or university during the internship.
Not employed at the time the internship starts.
Must be located in the United States for the internship duration.

Preferred Qualifications:

Ph.D. candidate in biochemistry, pharmacology, organic chemistry, pharmaceutical science, or a related biomedical field (in at least the 3rd year of graduate school).
Scientific knowledge in protein biochemistry, synthetic chemistry, microbiology, molecular biology, or cell biology.
Familiarity with AI tools for research.
Strong written communication skills.

What You Can Expect of Us
At Amgen, we support your professional and personal growth. In addition to competitive benefits, we offer opportunities for networking and community engagement. Here's what you can expect:

Base pay range: $30 - $40 per hour.
A chance to build a network of colleagues that will grow throughout your time with us.
Participate in executive and social networking events, as well as community volunteer projects.
Bring your authentic self and contribute to a culture that values diversity and flexibility.

Apply Now
For an internship that defies imagination, join us. Keyword: R-200490.

Application Deadline:
Amgen does not have a fixed deadline for this position; we will continue accepting applications until we have selected a candidate.

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Grad Intern - Global Regulatory Affairs Cmc

Job Description

Grad Intern - Global Regulatory Affairs CMC

Basic Qualifications:

Preferred Qualifications:

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