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Senior Clinical Disclosure Professional

5+ years
Not Disclosed
10 Feb. 24, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Position: Senior Clinical Disclosure Professional
Location: Bangalore, India
Job Category: Clinical Development


The Position:

Novo Nordisk is seeking a Senior Clinical Disclosure Professional to join our dynamic team. In this role, you will drive process improvements and ensure quality deliverables in clinical trial disclosure. If you have expertise in clinical trial disclosure and a passion for regulatory compliance, we invite you to apply for this life-changing opportunity.

Key responsibilities include:

  • Clinical Trial Disclosure: Perform disclosure tasks related to clinical trials, ensuring accurate and timely reporting.

  • Quality Control: Conduct quality control measures to ensure disclosure tasks meet high standards.

  • Skill Development: Drive skill development within the team to enhance competencies and ensure quality deliverables.

  • Process Improvement: Contribute to continuous improvement initiatives and promote a quality mindset within the team.

  • Stakeholder Collaboration: Foster collaboration with global colleagues to enhance project outcomes.

  • Resource Planning: Work with the manager to support resourcing requirements for the team.


Qualifications:

We are looking for candidates with the following qualifications:

  • Education: PhD, MSc, MPharm, MD, BDS, or an equivalent degree.

  • Experience:

    • Minimum of 5 years of experience in clinical trial disclosure, data evaluation, and communication, ideally in the pharmaceutical or CRO industry.

    • Knowledge of clinical drug development, GCP, and regulatory requirements.

    • Familiarity with EudraCT, CT.gov clinical trial registration, and transparency regulations.

    • Strong understanding of clinical trial methodology.

    • Previous experience working in an international, project-oriented environment.

    • Proficiency in using IT tools for clinical trial disclosure and transparency.


About the Department:

You will be part of the Clinical Reporting – GBS team. This department oversees clinical development activities from planning clinical trials to submitting regulatory documents to authorities. We offer a wide range of resources and support, including Biostatistics, Programming, Data Management, and Clinical Pharmacology, to ensure the smooth execution of clinical trials.