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Clinical Document Anonymization and Regulatory Compliance Specialist at GSK

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GSK

Masterโ€™s degree in life sciences.

Bengaluru

4 years

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Are you passionate about clinical research and data transparency? GlaxoSmithKline (GSK), a global leader in biopharma, is seeking an Associate Transparency Specialist – Document Anonymisation to join their team in Bengaluru, Karnataka. This role offers a unique opportunity to contribute to GSKโ€™s mission of uniting science, technology, and talent to advance healthcare. If you have expertise in clinical document anonymization and regulatory compliance, apply now to make a meaningful impact!


Key Responsibilities

As an Associate Transparency Specialist, you will play a critical role in ensuring clinical document anonymization aligns with GSKโ€™s high standards and global regulatory requirements. Your responsibilities include:

  • Preparing and anonymizing clinical documents per GSK standards and regulations like EMA Policy 0070 and Health Canada PRCI.
  • Overseeing vendors and offshore service providers to ensure quality and timely delivery.
  • Managing relationships with external partners to streamline anonymization processes.
  • Monitoring quality through robust quality control and assurance measures.
  • Resolving issues to meet disclosure timelines and priorities.
  • Developing procedural and training materials for document anonymization.
  • Ensuring consistency and compliance in R&D document storage and standards.

Qualifications

To excel in this role, candidates should possess:

  • Experience: Minimum 4 years in document anonymization, regulatory compliance, and stakeholder management.
  • Education: Masterโ€™s degree in life sciences.
  • Skills:
    • Strong understanding of clinical trial lifecycles, metadata, and data.
    • Familiarity with R&D and clinical development processes.
    • Expertise in EMA Policy 0070 and Health Canada PRCI (preferred).
    • Excellent verbal and written communication skills.
    • Ability to bridge scientific and non-scientific audiences.
    • Strong attention to detail and independence.
    • Teamwork and interpersonal skills for cross-functional collaboration.
    • Ability to manage conflicting demands in a high-pressure environment.
  • Preferred: Knowledge of medical writing, publishing, and regulatory processes; experience reviewing clinical documents.

Why Join GSK?

GSK is a global biopharma company dedicated to preventing and treating diseases through vaccines, specialty, and general medicines. By joining GSK, youโ€™ll:

  • Work in a dynamic, inclusive environment where your contributions matter.
  • Collaborate with cutting-edge teams in infectious diseases, HIV, respiratory/immunology, and oncology.
  • Be part of a culture that values growth, wellbeing, and innovation.
  • Contribute to impactful healthcare solutions for billions worldwide.

How to Apply

Application Link

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