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Associate Director, Global Regulatory Writing

5+ years
Not Disclosed
10 Dec. 14, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Here’s a revised and succinct version of the Senior Regulatory Medical Writer job description for Amgen:


Position: Senior Regulatory Medical Writer

Department: Global Regulatory Writing (GRW)
Location: Amgen


Defy Imagination with Amgen

At Amgen, we’re part of something bigger—a mission to serve patients. As one of the world’s leading biotechnology companies, we collaborate globally to deliver innovative medicines to over 10 million patients. Join us to transform lives and your career.


What You Will Do

In this vital role, you will lead the development of clinical and regulatory documents, ensuring that data is clearly and concisely presented in compliance with ICH guidelines and global regulatory standards. As a key contributor to submission strategies, you will guide product teams, provide scientific expertise, and uphold Amgen's reputation for excellence in regulatory submissions.


Key Responsibilities

Document Development and Oversight

  • Lead the creation of regulatory documents, including NDA/BLA submissions, INDs/CTAs, Protocols, Clinical Study Reports, and Orphan Drug Designation Requests.
  • Ensure adherence to ICH guidelines and global regulatory standards.
  • Oversee the authoring, review, and approval processes for key documents.

Team Leadership and Collaboration

  • Manage and mentor regulatory medical writers, fostering career growth and adherence to Amgen’s values.
  • Serve as the functional lead on Product Teams, guiding submission strategy and ensuring consistency across programs.
  • Collaborate with cross-functional teams to align messaging and meet submission timelines.

Operational Excellence

  • Develop project timelines and allocate resources to ensure timely delivery.
  • Participate in cross-functional initiatives, including process improvement and training program development.
  • Contribute to departmental operations, including resource planning, metrics generation, and budget management.

Innovation and Continuous Improvement

  • Lead the design of methods and processes to enhance the creation of regulatory outputs.
  • Integrate industry trends and data into plans and deliverables to maintain best-in-class standards.

Knowledge and Skills

  • Advanced expertise in scientific/technical writing and regulatory processes.
  • Proficiency in document management systems and Microsoft Office tools.
  • Strong leadership, analytical, and project management skills.
  • Comprehensive knowledge of ICH guidelines, GCP requirements, and clinical development.

What We Expect of You

Basic Qualifications:

  • Master’s degree with 10–14 years of regulatory writing experience OR
  • Bachelor’s degree with 14–16 years of regulatory writing experience OR
  • Diploma with 18–20 years of regulatory writing experience.
  • 3+ years of managerial or team leadership experience.

Preferred Qualifications:

  • 5+ years of regulatory writing in the Biotech/Pharmaceutical industry.
  • Expertise in regulatory submission processes and document types.
  • Advanced knowledge of ICH/GCP guidance and global regulatory requirements.

Why Join Amgen?

What We Offer:

  • Competitive salary and comprehensive Total Rewards Plans.
  • Opportunities for growth in a dynamic, inclusive, and collaborative environment.

Equal Opportunity Employer

Amgen is committed to creating a diverse and inclusive workplace. We provide reasonable accommodations for individuals with disabilities.


Ready to Transform Lives?

Apply now and join us in reshaping the future of healthcare.

Visit careers.amgen.com


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