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Senior Medical Writer
A company is looking for a Senior Medical Writer to author and contribute to clinical and regulatory documents. Key Responsibilities: Author clinical study protocols, amendments, IBs, and other supporting documents Co-author CSRs and data summaries for regulatory submissions, ensuring data integrity Advocate for best practices in Medical Writing and identify opportunities for process improvement Required Qualifications: Bachelor's degree in a scientific discipline; advanced degree is a plus Minimum of 4+ years of regulatory medical writing experience in the biotech/pharmaceutical industry Proven track record of managing clinical study documents and submissions Strong knowledge of global pharmaceutical regulations and guidelines Proficiency in word processing software and document management systems
A company is looking for a Senior Medical Writer to author and contribute to clinical and regulatory documents.
Key Responsibilities:
Author clinical study protocols, amendments, IBs, and other supporting documents
Co-author CSRs and data summaries for regulatory submissions, ensuring data integrity
Advocate for best practices in Medical Writing and identify opportunities for process improvement
Required Qualifications:
Bachelor's degree in a scientific discipline; advanced degree is a plus
Minimum of 4+ years of regulatory medical writing experience in the biotech/pharmaceutical industry
Proven track record of managing clinical study documents and submissions
Strong knowledge of global pharmaceutical regulations and guidelines
Proficiency in word processing software and document management systems