Regulatory Affairs Consultant - Fully Remote | Upto $170/hr
关于工作的职位,默科尔将精英创意和技术人才与领先的人工智能研究实验室联系起来。总部位于旧金山,我们的投资者包括 Benchmark,General Catalyst,Peter Thiel,Adam D'Angelo,Larry Summers 和 Jack Dorsey.职位:临床监管专家类型:合同补偿:130$~170$/小时 地点:远程承诺:2025小时/周角色责任 ·根据 FDA 证据标准和格式预期验证临床数据室和文件。·作者 FDA 信息请求和模型响应。设计提示,黄金输出和 rubrics 以量化 AI 代理能力。·确保遵守故意测试缺陷的监管判断。· 独立和异步地工作,以满足截止日期并提高 AI 模型性能。资格必须有5年以上监管角色经验。· MD, PhD, PharmD 或等级。· 在 CMC,患者水平数据,调查员资格以及生物标志物或终点证据中审查或响应 FDA 信息请求的经验。• 与当前联邦雇主没有利益冲突。优先 · 1025年的经验。· 关于面试过程和平台信息的详细信息,请查看:· 任何帮助或支持,联系:PS:我们的团队每天审查申请。请完成你的 AI 面试和申请步骤以考虑此机会。最初发布在喜马拉雅山脉
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About the job
Mercor connects elite creative and technical talent with leading AI research labs. Headquartered in San Francisco, our investors include Benchmark, General Catalyst, Peter Thiel, Adam D'Angelo, Larry Summers, and Jack Dorsey.
Position: Clinical Regulatory Expert
Type:Contract
Compensation:$130–$170/hour
Location:Remote
Commitment:20–25 hours/week
Role Responsibilities
- Validate clinical data rooms and documents against FDA evidentiary standards and formatting expectations.
- Author FDA information requests and model responses. Design prompts, golden outputs, and rubrics to quantify AI agent capabilities.
- Ensure compliance with deliberate defects testing regulatory judgment.
- Work independently and asynchronously to meet deadlines and improve AI model performance.
Qualifications
Must-Have
- 5+ years of experience in regulatory roles.
- MD, PhD, PharmD, or equivalent.
- Experience reviewing or responding to FDA information requests across CMC, patient-level data, investigator qualifications, and biomarker or endpoint evidence.
- No conflict of interest with a current federal employer.
Preferred
- 10–25 years of experience.
- Direct FDA review experience preferred over sponsor-side liaison work.
Application Process (Takes 20–30 mins to complete)
- Upload resume
- AI interview based on your resume
- Submit form
Resources & Support
- For details about the interview process and platform information, please check:
- For any help or support, reach out to:
PS: Our team reviews applications daily. Please complete your AI interview and application steps to be considered for this opportunity.
Originally posted on Himalayas