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    Regulatory Writing Manager

    Amgen
    3-12 years
    Not Disclosed
    Hyderabad
    10 Oct. 9, 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 to Serve Patients

    At Amgen, you’re part of something bigger. Our shared mission—to serve patients facing serious illnesses—drives everything we do.

    Since 1980, we’ve pioneered the biotech industry, tackling some of the world’s toughest diseases. Focusing on four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease—we reach millions of patients each year. As an Amgen team member, you’ll have the opportunity to make a lasting impact on patients’ lives by researching, manufacturing, and delivering innovative medicines that help people live longer, healthier lives.

    Our award-winning culture is collaborative, innovative, and science-driven. If you thrive on challenges and the opportunities they present, you’ll excel at Amgen. Join us in transforming the lives of patients while advancing your career.

    What You Will Do

    Let’s make a difference together. In this vital role, you will:

    • Author regulatory submission documents, including Clinical Study Reports, Investigator Brochures, Protocols, Informed Consent Forms, and more.
    • Conduct formal reviews and approvals of authored documents, adhering to standard operating procedures.
    • Manage regulatory writing activities for product submissions, including new and supplemental drug applications/biologics license applications, with considerable supervision.
    • Serve as a functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team).
    • Provide input for the Global Regulatory Plan and team goals as needed.
    • Collaborate with contract and freelance writers.
    • Participate in the training and mentoring of junior medical writers.
    • Contribute to departmental and cross-departmental initiatives as appropriate.
    • Generate document timelines with team input.
    • Stay updated on relevant professional information and technology.

    What We Expect From You

    We value unique contributions in our mission to serve patients. The ideal candidate possesses:

    Basic Qualifications:

    • Doctorate degree OR
    • Master’s degree with 3 years of directly related experience OR
    • Bachelor’s degree with 5 years of directly related experience OR
    • Associate’s degree with 10 years of directly related experience OR
    • High school diploma/GED with 12 years of directly related experience

    Preferred Qualifications:

    Functional Skills:

    • Proficiency in word processing and Microsoft Office programs
    • Strong knowledge of scientific/technical writing and editing, as well as the clinical development process
    • Ability to understand and follow complex standard operating procedures (SOPs) and guidance documents
    • Understanding of International Council on Harmonization (ICH) and Good Clinical Practice (GCP) guidelines

    Soft Skills:

    • Excellent written and oral communication skills, with a keen attention to detail
    • Leadership abilities in a team environment, demonstrating negotiation, collaboration, and analytical judgment
    • Strong time and project management skills
    • Self-starter with a drive to achieve results

    What You Can Expect From Us

    As we develop treatments for others, we also prioritize your professional and personal growth. From competitive benefits to a supportive culture, we’re committed to your journey every step of the way.

    In addition to a competitive salary, Amgen offers a comprehensive Total Rewards Plan aligned with industry standards.

    Apply Now

    Embark on a career that defies imagination. Your future at Amgen is closer than it appears.

    careers.amgen.com

    Amgen is committed to fostering an inclusive environment of diverse, ethical, and highly accomplished individuals. We respect each other and uphold the values that drive our mission to advance science for patients.

    Amgen is an Equal Opportunity employer and welcomes all qualified applicants regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

    We are dedicated to providing reasonable accommodations for individuals with disabilities to participate in the application or interview process, perform essential job functions, and access benefits and privileges of employment. Please contact us to request accommodations.

    Apply Now!

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    Warsaw |

    Remote :

    Remote - Africa | McFarland | Nairobi | Xzagreb | Riga | Medan | Thailand | Remote - Europe | Castlebar | Lenexa | Remote - Middle East | Leinster | Remote | Ireland | Switzerland | Lousiana | Zaragoza | Remote, USA | Melbourne | Bishop | Springville | Victoria | Hungary | Manipal | Texas | Bountiful | Tulsa | Hammond | Green Way | Belgium | French | Blue Bell | Slovakia | Minnesota | Faridabad | Remote - South America (Latin Americal) |

    Bucharest :

    Bucharest |

    Makkah :

    Rabigh | Riyadh | Khulais | Jeddah | King Abdullah Economic City | Najran |

    Nišava District :

    Niš |

    Singapore :

    Singapore |

    South Africa :

    South Africa | Midrand |

    Brazil :

    Sao paulo | Brazil |

    South America :

    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 |