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Clinical Trials Disclosure Senior Associate

4-9 years
Not Disclosed
10 July 31, 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 Senior Associate – Amgen, Hyderabad

Job Summary:
Amgen is seeking a Clinical Trials Disclosure Senior Associate for its Hyderabad office. This role involves the preparation, redaction, and public disclosure of clinical regulatory documents in compliance with global standards. Ideal candidates will have 4–9 years of experience in regulatory document handling within clinical research settings. This is an on-site opportunity.


Key Responsibilities:

  • Prepare clinical regulatory documents for public disclosure

  • Anonymize personal data and redact confidential information

  • Define and document redaction strategies

  • Collaborate with cross-functional stakeholders for review and approval

  • Ensure submission readiness and timely document posting

  • Communicate and resolve disclosure-related issues

  • Support process improvement and trend analysis initiatives


Required Skills & Qualifications:

  • 4–9 years of experience in clinical trial disclosure or related regulatory documentation

  • Strong knowledge of clinical regulatory documents and disclosure regulations

  • Familiarity with clinical research practices

  • High attention to detail and strong organizational skills

  • Excellent written and spoken English

  • Strong project management and problem-solving abilities

  • Ability to work independently while following controlled processes

  • Strong negotiation and communication skills


Perks & Benefits:

  • Competitive compensation (not explicitly mentioned; inquire during interview)

  • Inclusive and ethical workplace environment

  • Professional growth in a global biopharmaceutical leader

  • Equal opportunity employer with accommodation support for applicants with disabilities


Company Description:

Amgen is a global leader in biotechnology, leveraging biology and cutting-edge technology to develop innovative therapies for serious illnesses. With over 40 years of industry leadership, Amgen remains at the forefront of scientific innovation and patient-focused care.


Work Mode: On-site (Hyderabad, India)


Call-to-Action:
Ready to drive meaningful change in global clinical research transparency? Apply now to join Amgen as a Clinical Trials Disclosure Senior Associate and help ensure patient-centric communication in medical science.