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Regulatory Writing Sr Mgr

14-18 years
Not Disclosed
10 Dec. 5, 2024
Job Description
Job Type: Full Time Education: BS/MS 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.

In this pivotal role, you will:

  • Prepare and Oversee the creation of regulatory submission documents that adhere to global regulatory standards.
  • Write or Supervise clinical study reports and Investigator Brochures for products across all clinical development phases (Phase 1 to Phase 4).
  • Author CTD Sections including Summary of Clinical Efficacy, Summary of Clinical Safety, Summary of Clinical Pharmacology, Summary of Biopharmaceutics, Clinical Overview, Table of All Studies, briefing documents, and safety narratives.
  • Develop Other Regulatory Documents, such as RTQs, PIPs, white papers, breakthrough therapy applications, and orphan drug applications.
  • Manage Study Timelines for regulatory documents and oversee regulatory submission strategies.
  • Act as a Functional Lead, representing medical writing within product teams.
  • Mentor and Guide Medical Writers, fostering growth and expertise within the team.
  • Supervise the GRW Staff to ensure efficient project delivery.
  • Contribute to Departmental Governance, including hiring, resourcing, and strategic planning for therapeutic areas and project teams.
  • Ensure Quality in regulatory submission documents at every development stage.
  • Provide Expertise in document design and good medical writing practices.
  • Collaborate Across Departments, participating in departmental and cross-functional initiatives to enhance processes and outcomes.

What We Expect of You

We value unique perspectives and diverse strengths to achieve our mission. Here’s what we are looking for in the ideal candidate:

Basic Qualifications:

  • Doctorate degree with 2 years of experience in regulatory or scientific document writing, OR
  • Master’s degree with 8–10 years of relevant experience, OR
  • Bachelor’s degree with 10–14 years of relevant experience, OR
  • Diploma with 14–18 years of relevant experience.

Preferred Qualifications:

  • BS, MS, or advanced degree in biology, chemistry, or a related scientific field.
  • Proven experience in writing clinical and regulatory documents.
  • Strong skills in negotiation, collaboration, and analytical judgment.
  • Advanced ability to analyze medical data and derive meaningful interpretations.
  • Deep knowledge of regulatory guidance (e.g., ICH) and compliance standards.
  • Excellent written and oral communication skills with a strong focus on detail.
  • Expertise in project and time management, negotiation, and leadership.
  • Experience mentoring and directing others within a team environment.

What You Can Expect from Us

As we strive to improve patient outcomes, we are equally committed to fostering your professional and personal development.

  • Competitive salary packages with comprehensive Total Rewards Plans aligned with industry standards.
  • A collaborative and inclusive workplace culture to support your journey at every step.

Ready to Make a Difference?

Apply now for a career that goes beyond imagination. Join us in making an impact.

Explore Opportunities at Amgen