Senior Clinical Regulatory Document Specialist

1 week ago


Bengaluru, Karnataka, India ScaleneWorks Full time
Job Description

We are seeking a highly skilled Senior Clinical Regulatory Document Specialist to join our team at ScaleneWorks. In this role, you will be responsible for driving the development of high-quality clinical regulatory documents, including protocols, clinical study reports, and NDA/MAA CTD submission documents.

Key Responsibilities:
  • Develop and execute complex writing assignments involving a thorough understanding of clinical trial designs and interpretation of statistically analyzed research data.
  • Coordinate the process to draft, review, and approve written assignments, ensuring accuracy and compliance with global pharma company standards and global, regional, and local regulatory requirements.
  • Plan and prioritize projects without supervision, managing multiple tasks and deadlines effectively.
  • Collaborate with cross-functional teams to ensure delivery of high-quality clinical documents that accurately reflect associated data.
  • Proven track record in writing clinical regulatory documents, including protocols, clinical study reports, investigator brochures, briefing documents, and responses to regulatory authority questions.
Requirements:
  • PhD or relevant working experience within the life sciences space.
  • Clinical regulatory writing experience in the pharmaceutical industry.
  • Demonstration of leadership and ability to work in multicultural settings.
  • Excellent English language skills (verbal and written).
  • Working knowledge of International Committee for Harmonisation (ICH)/Good Clinical Practice (GCP).
Estimated Salary: $120,000 - $160,000 per year

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