Instagram
youtube
Facebook

Regulatory Writing Manager

10-12 years
Not Disclosed
10 Dec. 5, 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

Let’s Do This. Let’s Change the World.

Join Amgen, where your contributions make a lasting impact. In this pivotal role, you'll lead the development of critical regulatory submission documents, collaborate with cross-functional teams, and mentor peers to ensure the successful delivery of innovative therapies to patients globally.


What You Will Do

In this vital role, you will:

  • Author Regulatory Submission Documents:
    Prepare Clinical Study Reports, Investigator Brochures, Protocols, Amendments, Informed Consent Forms, eCTD Module 2 summaries, and other regulatory documentation.
  • Review and Approve Documents:
    Conduct formal reviews adhering to applicable SOPs and regulatory standards.
  • Manage Submission Activities:
    Oversee writing tasks for product submissions, including drug applications and biologics license applications, with guidance.
  • Collaborate Across Teams:
    Act as a functional lead on product teams, contributing to global regulatory plans and goals.
  • Mentor and Train Peers:
    Provide support to junior writers, contract staff, and freelancers.
  • Drive Innovation:
    Participate in departmental initiatives and keep abreast of evolving professional knowledge and technology.
  • Ensure Timely Deliverables:
    Create and manage document timelines with input from team members.

What We Expect of You

Every Amgen team member brings unique strengths and skills to serve patients effectively.

Basic Qualifications

  • Doctorate degree, or
  • Master’s degree with 4–6 years of relevant experience, or
  • Bachelor’s degree with 6–8 years of relevant experience, or
  • Diploma with 10–12 years of relevant experience.

Preferred Qualifications

  • Proficiency with Microsoft Office and word processing tools.
  • In-depth knowledge of scientific/technical writing and editing for clinical development.
  • Strong understanding of ICH and GCP guidelines.
  • Ability to interpret and apply complex SOPs, guidance documents, and work instructions.
  • Expertise in scientific/technical principles and industry standards.

Soft Skills

  • Exceptional communication and attention to detail.
  • Strong leadership and collaboration abilities in a team setting.
  • Advanced time management and organizational skills.
  • Self-driven with perseverance to achieve results.

What You Can Expect of Us

At Amgen, your well-being and career growth are our priorities. We offer:

  • Competitive and comprehensive Total Rewards Plans aligned with local industry standards.
  • A culture that champions innovation, collaboration, and inclusivity.
  • Opportunities for continuous learning and career development.

Equal Opportunity Statement

Amgen is an Equal Opportunity employer, welcoming candidates regardless of race, color, religion, gender, sexual orientation, national origin, veteran status, or disability. Reasonable accommodations are provided to ensure equal access throughout the hiring process.


Apply Now

Transform lives, including your own. Join us today at careers.amgen.com.

Objects in your future are closer than they appear.
Join Amgen.