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Clinical Trials Disclosure Manager

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 streamlined version of the Clinical Transparency and Disclosure Specialist job description:


Position: Clinical Transparency and Disclosure Specialist

Department: Regulatory Affairs
Location: Amgen


About Amgen

Amgen blends biology and technology to tackle the world’s toughest diseases, helping people live longer, fuller lives. As a pioneer in biotechnology for over 40 years, we leverage innovation and human genetic data to push beyond today’s boundaries.


What You Will Do

Let’s change the world. In this pivotal role, you will oversee the preparation of clinical regulatory documents for public disclosure. This includes the anonymization of personal data and redaction of commercially confidential information in compliance with global regulations and best practices.

Key Responsibilities:

  • Regulatory Document Preparation:

    • Lead the redaction of clinical documents, ensuring compliance with applicable regulations and company policies.
    • Collaborate with cross-functional teams to define and implement redaction strategies.
    • Conduct and lead reviews, approvals, and submission-readiness checks for public disclosure.
  • Project Management:

    • Manage timelines, coordinate team efforts, and prioritize tasks to meet external deadlines.
    • Oversee trend analysis and support continuous improvement initiatives.
  • Team Collaboration:

    • Partner with the transparency team and stakeholders to ensure alignment on objectives.
    • Provide training and guidance on best practices for clinical transparency and disclosure.

What We Expect of You

Basic Qualifications:

  • Master’s degree with 4–6 years of pharmaceutical industry experience, OR
  • Bachelor’s degree with 6–8 years of pharmaceutical industry experience, OR
  • Diploma with 10–12 years of pharmaceutical industry experience.
  • At least 2 years of experience preparing regulatory documents for public disclosure.

Preferred Qualifications:

  • Familiarity with international regulations and guidelines on clinical transparency and the protection of personal/commercially confidential information.
  • Strong project management and organizational skills.
  • Proven leadership abilities, including training, negotiation, and influencing others.
  • Proficiency in interpreting and applying complex data/information.
  • Excellent communication skills, both written and verbal.

Why Join Amgen?

We are committed to creating an inclusive, innovative workplace where employees thrive while making a global impact. Our culture emphasizes collaboration, integrity, and excellence.

Equal Opportunity Employer
Amgen provides equal opportunities for all applicants and is committed to diversity and inclusion. Reasonable accommodations are available for individuals with disabilities.


Apply now and help redefine what’s possible in the world of biotechnology.
Visit careers.amgen.com


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