REGULATORY AFFAIRS CONSULTING SUPPORT SERVICES

这项研究是NIH帮助结束成瘾长期(Hear)倡议的一部分，该倡议旨在加快科学解决方案，以了解疼痛的基础并加强临床疼痛管理。 医疗写作顾问将负责为NIH项目准备和提交高质量的监管和其他支持文件。顾问将与LDTS协调，在项目时间表内准备、编辑、审查文件，并将文件提交给监管机构(例如FDA)。文件可能包括但不限于临床方案、新药研究申请(IND)、研究人员手册(IBS)、IND修正案、药物总档案、研究人员声明(FDA 1572表)和药物档案。

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.