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Clinical Trials Disclosure Senior Associate

2+ 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 revised, concise, and polished version of the Clinical Regulatory Disclosure Specialist job description:


Position: Clinical Regulatory Disclosure Specialist

Department: Clinical Transparency
Location: Amgen


About Amgen

Amgen combines biology and technology to combat the world’s toughest diseases and improve lives. As a biotechnology pioneer for over 40 years, we develop, manufacture, and deliver groundbreaking medicines that reach millions of patients worldwide. Our innovative use of human genetic data and cutting-edge technology propels us beyond the boundaries of today’s science.


What You Will Do

Let’s change the world together. In this essential role, you will ensure clinical regulatory documents are prepared for public disclosure while adhering to global standards and guidelines.

Key Responsibilities:

  • Prepare clinical regulatory documents for public disclosure, including anonymizing personal data and redacting commercially confidential information.
  • Collaborate with cross-functional teams to define redaction strategies, manage reviews and approvals, and ensure submission readiness.
  • Maintain consistent quality across documents and facilitate timely submission or posting.
  • Record and maintain redaction strategies for studies and products.
  • Address and escalate issues as needed while maintaining proactive communication with team members.
  • Contribute to trend analysis and continuous process improvements.

What We Expect of You

Basic 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.
  • At least 2 years of experience in preparing regulatory documents for public disclosure.

Preferred Qualifications:

  • Familiarity with clinical research processes and regulatory documentation.
  • Knowledge of clinical trial disclosure regulations, guidelines, and best practices.
  • Strong project management skills with the ability to prioritize tasks and meet deadlines.
  • Proficiency in interpreting data and applying it practically.
  • Excellent problem-solving, negotiation, and influencing skills.
  • Advanced proficiency in written and spoken English.
  • High attention to detail with a self-motivated, results-driven mindset.

Why Join Amgen?

At Amgen, we are united by a mission to serve patients and make a global impact. Our culture fosters innovation, collaboration, and professional growth.

Equal Opportunity Employer
Amgen provides equal opportunities for all applicants and is committed to creating an inclusive workplace. Reasonable accommodations are available for individuals with disabilities.


Apply Now
Make your next career move meaningful. Join us at careers.amgen.com.


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