REGULATORY AFFAIRS CONSULTING SUPPORT SERVICES

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Medical Writing consultants will be responsible for the preparation and submission of high-quality regulatory and other supporting documents for NIH projects. The consultants will coordinate with LDTs to prepare, edit, review, and submit documents to regulatory agencies (e.g., FDA) within project timelines. Documents may include but are not limited to clinical protocols, Investigational New Drug applications (INDs), Investigator Brochures (IBs), IND Amendments, Drug Master Files, and Statement of Investigators (Form FDA 1572) and drug dossiers.