REGULATORY AFFAIRS CONSULTING SUPPORT SERVICES

这项研究是美国国立卫生研究院帮助结束长期成瘾（HEAL）倡议的一部分，旨在加速科学解决方案，以了解疼痛的基础并加强临床疼痛管理。

This study is part of the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to understand the basis of pain and enhance clinical pain management. 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.