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Clinical Trials Disclosure Associate

1+ years
Not Disclosed
10 March 3, 2025
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

Clinical Trials Disclosure Associate

Location: Hyderabad, India
Job ID: R-205348
Work Location Type: On-Site
Category: Clinical
Date Posted: Feb. 24, 2025

About Amgen:

Amgen combines biology and technology to combat the world’s most challenging diseases, aiming to enhance and extend lives. As a pioneer in biotechnology for over 40 years, we continue to drive innovation through cutting-edge technology and human genetic data.

Role: Clinical Transparency & Disclosure Sr. Associate

Department: Global Regulatory Affairs & Strategy (GRAAS)
Hiring Manager: Jennifer Vande Weghe
Role GCF: 3

Key Responsibilities:

  • Prepare clinical regulatory documents for public disclosure, including data anonymization and redaction of commercially confidential information.
  • Ensure consistent quality across documents and readiness for submission or public posting.
  • Collaborate with cross-functional teams to resolve issues and escalate concerns as needed.
  • Maintain a written redaction strategy for studies and products.
  • Manage timelines and coordinate work across teams to ensure regulatory compliance.

Required Skills:

  • Ability to understand and interpret data for practical applications.
  • Strong attention to detail, multi-tasking, and follow-through.
  • Ability to adhere to controlled processes with accuracy.
  • Fluent spoken and written English.
  • Project management skills, with the ability to prioritize tasks to meet deadlines.
  • Problem-solving ability and a structured approach to challenges.

Qualifications:

Basic Qualifications:

  • Bachelor’s degree.
  • Minimum 1 year of experience working with regulatory documents in a biotech/pharmaceutical setting.
  • Familiarity with clinical research and clinical regulatory documents.
  • Knowledge of clinical trial disclosure regulations, guidelines, and best practices.

Preferred Qualifications:

  • 1 year of experience preparing regulatory documents for public disclosure.

Equal Opportunity Statement:

Amgen is an Equal Opportunity Employer, ensuring fair consideration for all applicants regardless of race, gender, religion, sexual orientation, disability, or veteran status.

Reasonable accommodations are available for individuals with disabilities to support their participation in the application process, job functions, and employment benefits.

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