Added
25 days ago
Type
Full time
Salary
Salary not provided

Related skills

regulatory affairs clinical trials medical writing health canada clinicaltrials.gov

๐Ÿ“‹ Description

  • Independently lead the preparation, review, and delivery of clinical trial transparency and
  • Develop and review protocol registrations, results postings, plain language summaries (PLS), lay
  • Apply advanced medical writing expertise to clinical and regulatory documents, including study
  • Provide strategic and regulatory guidance to clients and internal teams on clinical trial
  • Lead client interactions and provide consultation on complex disclosure and regulatory matters.
  • Manage complex disclosure projects independently from initiation through final delivery, ensuring

๐ŸŽฏ Requirements

  • Demonstrated professional experience in medical writing, with significant specialized expertise in
  • Thorough knowledge of global clinical trial disclosure requirements and platforms, including
  • Extensive experience with protocol registration, results reporting, registry maintenance, and
  • Strong understanding of health literacy principles and proven ability to develop clear, accessible
  • Thorough knowledge of data protection requirements and their practical application to anonymization
  • Advanced expertise in identifying, assessing, and justifying personally identifiable data (PPD) and

๐ŸŽ Benefits

  • Full-time remote position based in Bengaluru, India.
  • Opportunity to work on global clinical research and clinical trial transparency projects.
  • Exposure to complex regulatory requirements across multiple international jurisdictions.
  • Opportunity to collaborate with global clients and multidisciplinary clinical research teams.
  • Professional development through mentoring, regulatory expertise, and involvement in process
  • Meaningful opportunity to contribute to greater clinical research transparency and patient access
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