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    Grad Intern - Global Regulatory Affairs Cmc

    Amgen
    Freshers years
    Not Disclosed
    Remote, USA
    11 Nov. 26, 2024
    Job Description
    Job Type: Full Time Remote 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, you’re not just part of a company, you’re part of a movement. Our shared mission—to serve patients living with serious illnesses—drives everything we do. Since 1980, we’ve pioneered biotech in the fight against the world’s toughest diseases. By focusing on four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease—we reach millions of patients every year. Join Amgen, and make a lasting impact on patients' lives while transforming your career.

    Grad Intern - Global Regulatory Affairs CMC

    What You Will Do
    Let’s change the world together! During this internship, you will work in the Global Regulatory Affairs Chemistry, Manufacture, and Controls (CMC) team, supporting Amgen’s commercial product portfolio. The goal of this internship is to collect global regulatory intelligence and help develop processes and tools that support the effective compilation of post-approval CMC regulatory activities. You’ll gain valuable experience in understanding the responsibilities of a CMC regulatory scientist. The internship objectives include:

    • Collecting regulatory intelligence for managing post-approval regulatory activities.
    • Assisting in the development of processes and tools to manage post-approval submissions efficiently.
    • Participating in group meetings and assignments to understand CMC regulatory responsibilities.

    What We Expect of You
    Amgen is looking for 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 related biomedical field) and completed at least one year of graduate study before the internship starts.
    • Enrolled in an accredited college or university during the internship.
    • Must not be employed at the time the internship begins.
    • Must be located in the U.S. for the duration of the internship.

    Preferred Qualifications:

    • Ph.D. candidate in biochemistry, pharmacology, organic chemistry, pharmaceutical science, or a related field (at least in the 3rd year of graduate school).
    • Scientific knowledge in protein biochemistry, synthetic chemistry, microbiology, molecular biology, and/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. Along with competitive benefits, we provide a collaborative culture that fosters your development. Here’s what you can expect:

    • Base pay range: $30 - $40 per hour.
    • Build lasting networks with colleagues across the organization.
    • Participate in executive and social networking events, as well as community volunteer projects.
    • Be your authentic self in 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 set deadline for this position. We will accept applications until we find the right candidate.

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    Peru | Argentina |

    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Sweden :

    Sweden |

    Taipei :

    Taipei |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Kyiv Oblast :

    Kyiv |

    Dubai :

    Dubai |

    Hà Nội :

    Hà Nội | Hanoi |

    Ho Chi Minh :

    Ho Chi Minh City |