
Senior Medical Writer
2 days ago
About Our Client:
Our Client is a global IT services company headquartered in Southborough, Massachusetts, USA. Founded in 1996, the company specializes in digital engineering and IT services helping clients modernize their technology infrastructure, adopt cloud and AI solutions, and accelerate innovation.
The company operates in over 50 locations across more than 25 countries, has delivery centers in Asia, Europe, and North America and is backed by leading investors.
Job Title: Clinical Document Authoring
Key Responsibilities:
- Author and analyze clinical trial documents.
- Work with key clinical documents: 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.
- 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.
Requirements:
• 1-5 years of experience in clinical research associate roles.
• Any graduation degree.
• Hybrid work mode available.
• Employment type: Contract.
• Notice period: Immediate - 15 Days.
• Interview Mode: 2 Rounds of Technical Interview.
Benefits:
• Competitive salary package.
• Opportunities for career growth and professional development.
• Collaborative and dynamic work environment.
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