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Regulatory Writing Mgr

10-12 years
Not Disclosed
10 Dec. 23, 2024
Job Description
Job Type: Full Time Education: PhD/BSc/MSc/DPharma/PharmD/MBBS/BDS/BAMS/BHMS/MD 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

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Join Amgen’s Mission to Serve Patients

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

Since 1980, we’ve been at the forefront of biotechnology, tackling the world’s toughest diseases. With a focus on Oncology, Inflammation, General Medicine, and Rare Disease, we impact millions of lives annually. By joining our team, you’ll help deliver groundbreaking medicines that enable people to live longer, fuller, and happier lives.

Our award-winning culture fosters collaboration, innovation, and science-based problem-solving. If you’re passionate about challenges and the opportunities they create, you’ll thrive with us. Join Amgen to transform patients' lives while advancing your career.


What You Will Do

Let’s do this. Let’s change the world.

In this pivotal role, you will author and gain approval for scientific and regulatory submission documents aligned with global standards. You’ll collaborate with cross-functional product teams and may serve as a functional area lead, manage writing activities, mentor junior writers, and contribute to departmental initiatives.

Key Responsibilities:

  • Author Regulatory Documents: Clinical Study Reports, Investigator Brochures, Protocols, eCTD Module 2 Clinical Summary Documents, and more.
  • Manage Submission Writing Activities: Including new and supplemental drug applications/biologics license applications.
  • Collaborate Across Teams: Serve as the functional lead for product teams, such as the Global Regulatory Team and Label Working Group.
  • Mentorship and Training: Train junior medical writers and contribute to cross-departmental initiatives.
  • Ensure Compliance: Follow applicable SOPs, guidance documents, and work instructions during document reviews and approvals.
  • Project Management: Generate and manage document timelines with team input.

What We Expect of You

We celebrate diversity and leverage unique contributions to serve patients better.

Basic Qualifications:

  • Doctorate degree OR
  • Master’s degree with 4-6 years of directly related experience OR
  • Bachelor’s degree with 6-8 years of directly related experience OR
  • Diploma with 10-12 years of directly related experience.

Preferred Qualifications:

Functional Skills:

  • Proficiency with Microsoft Office tools, especially Word.
  • Comprehensive understanding of scientific writing, editing, and clinical development processes.
  • Strong knowledge of ICH, GCP guidelines, and regulatory requirements.

Soft Skills:

  • Excellent written and oral communication skills.
  • Leadership abilities, with strengths in negotiation, collaboration, and analytical judgment.
  • Effective time and project management skills.
  • Self-starter with determination and a results-driven mindset.

What You Can Expect From Us

We’re committed to supporting your professional growth and well-being. Amgen offers competitive benefits and a collaborative culture to support your journey every step of the way.

Equal Opportunity Statement:
Amgen is an Equal Opportunity employer. We evaluate applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Reasonable Accommodations:
Individuals with disabilities are encouraged to request reasonable accommodations for any part of the job application or interview process.


Apply Now
Transform your career while transforming lives.

Join us at careers.amgen.com for a future that defies imagination.


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