Senior Regulatory Affairs Specialist

3 days ago

Nashik, Maharashtra, India beBeeClinical Full time ₹ 18,00,000 - ₹ 24,00,000

About People Prime Worldwide:

We are a global IT services company with deep industry expertise and agile development practices.

Our focus is on digital engineering and IT services, helping clients modernize their technology infrastructure and adopt cloud and AI solutions.

Our team operates in over 50 locations across more than 25 countries, has delivery centers in Asia, Europe, and North America, and is backed by leading private equity firms.

Job Title: Clinical Document Authoring

Key Responsibilities:

  • Author and analyze clinical trial documents.
  • Work with key clinical documents such as Protocol, Informed Consent Form, Clinical Study Report, Summary of Clinical Safety/Efficacy, Access Evidence Dossier, Statistical Analysis Plan, and more.
  • Create, validate, and refine prompts for AI-assisted document generation.
  • Apply knowledge of clinical trial phases, study design, and drug development.
  • Maintain compliance with global regulatory standards (FDA, EMA, ICH-GCP).
  • Utilize medical terminologies and ontologies for clarity and consistency.
  • Ensure quality control and timely delivery of assigned tasks.
  • Collaborate with cross-functional teams to improve document accuracy and prompt effectiveness.
  • Provide regular updates and flag risks to the project manager.

Skillset: Protocol, Informed Consent Form (ICF), FDA, EMA, ICH-GCP, Medical Terminologies, Ontologies

Requirements:

  • 1-5 years of experience.
  • Any graduation degree.

This role requires strong analytical and communication skills, attention to detail, and ability to work in a fast-paced environment.

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