
Clinical Content Specialist
4 days ago
About Our Client:
Our Client is a global IT services company headquartered in Southborough, Massachusetts. Founded in 1996, it specializes in digital engineering and IT services, helping clients modernize their technology infrastructure.
Job Title: Clinical Document Authoring
Skills: Protocol , Informed Consent Form (ICF) , FDA , EMA , ICH-GCP
Benefits:
- Hybrid work mode to balance flexibility with teamwork.
- Contract employment for those seeking short-term engagements.
Key Responsibilities:
We are looking for a skilled Clinical Document Author to join our team. The ideal candidate will have expertise in authoring and analyzing clinical trial documents. They will work closely with key stakeholders to create high-quality content that meets regulatory standards.
- Author and analyze clinical trial documents, ensuring compliance with FDA, EMA, and ICH-GCP regulations.
- Create, validate, and refine prompts for AI-assisted document generation.
- Apply knowledge of clinical trial phases, study design, and drug development to produce accurate and informative documents.
- Maintain quality control and timely delivery of assigned tasks.
- Collaborate with cross-functional teams to improve document accuracy and prompt effectiveness.
Required Skills and Qualifications:
To succeed in this role, the candidate should possess excellent communication skills, attention to detail, and the ability to work independently in a fast-paced environment. They should also be proficient in medical terminologies and ontologies.
Additional Benefits:
As a valued member of our team, you can expect regular updates and opportunities for growth and development.
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