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Clinical Trials Disclosure Senior Associate

7-9 years
Not Disclosed
10 Dec. 14, 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

Here's a tailored description of the Amgen Clinical Regulatory Documentation Specialist role:


Position: Clinical Regulatory Documentation Specialist

Company: Amgen
Location: [Specific location if provided, or mention "Various Locations"]


About Amgen

Amgen has been at the forefront of biotechnology innovation for over 40 years. We combine biology and advanced technology to address the world’s toughest diseases, improving the quality and longevity of millions of lives. As a pioneer in the biotech industry, we leverage human genetic data and cutting-edge science to develop and deliver innovative therapies for patients worldwide.


Key Responsibilities

As a Clinical Regulatory Documentation Specialist, you will:

  • Prepare clinical regulatory documents for public disclosure, including anonymizing personal data and redacting commercially confidential information.
  • Collaborate with cross-functional stakeholders to define redaction strategies, lead reviews and approvals, and ensure submission readiness for timely posting.
  • Maintain consistent quality across documents, ensuring submission readiness.
  • Communicate effectively with team members to resolve issues and escalate challenges when necessary.
  • Document and maintain written redaction strategies for studies and products.
  • Support trend analysis and contribute to process improvement initiatives.

What We Expect from You

Educational Qualifications

  • Master’s degree with 1–3 years of relevant experience, OR
  • Bachelor’s degree with 3–5 years of relevant experience, OR
  • Diploma with 7–9 years of relevant experience.

Experience and Skills

  • At least 2 years of experience preparing regulatory documents for public disclosure.
  • Strong understanding of clinical research and regulatory documents.
  • Knowledge of clinical trial disclosure regulations, guidelines, and best practices.
  • Proven ability to interpret data and apply it practically.
  • Self-motivated, with excellent attention to detail and ability to manage multiple tasks.
  • Strong project management skills, including prioritization to meet deadlines.
  • Proficiency in spoken and written English, with excellent communication and problem-solving abilities.
  • Ability to negotiate and influence effectively within cross-functional teams.
  • Familiarity with following controlled processes.

What We Offer

  • A diverse and inclusive workplace committed to equal opportunities for all.
  • Reasonable accommodations for individuals with disabilities to support job applications, interviews, and essential job functions.

Why Join Amgen?

At Amgen, you’ll have the opportunity to contribute to groundbreaking innovation in healthcare. Be part of a team that’s transforming science into life-changing medicines and creating a healthier world for future generations.


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