Senior Regulatory Scientific Advisor

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

⏱ Part Time

🟠 Senior

🚔 Compliance

👻 Ghost score 11%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Evolution Research Group

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2014

💼 Consulting

🏥 Healthcare

🧬 Biotechnology

Consulting • Healthcare • Biotechnology

Evolution Research Group is a clinical research organization dedicated to advancing medical science through innovative clinical trials. Specializing in therapeutic areas such as psychiatry, neurology, pain management, addiction, and various chronic conditions, ERG collaborates with healthcare providers and advocacy organizations to ensure inclusivity and thorough patient recruitment. With a robust database of potential participants and expertise in early-phase trials, Evolution Research Group aims to transform healthcare by supporting the development of life-changing therapies.

📋 Description

• Provide senior-level regulatory and scientific guidance on FDA guidance and regulatory requirements as they apply to clinical research • Perform clinical reviews and advise on findings • Advise on clinical trial design, including protocol development and review, trial conduct, and analysis of trial data • Offer scientific opinions on development programs and the impact of regulatory expectations • Participate in Scientific Leadership Team meetings, generally Mondays and Wednesdays from 4:00–5:00 pm Eastern Time • Review meeting agendas, topics, protocols, and related materials in advance • Learn about new opportunities under consideration and provide opinions • Request involvement in projects where the company is open to it • Agree in advance with company leadership on anticipated hours for specified advisory work • Take on special projects only when discussed and approved in advance • Maintain confidentiality of company materials, information, and business plans • Perform other duties supporting clinical research and development activities

🎯 Requirements

• Medical degree (MD) or equivalent advanced scientific degree required • Extensive senior-level experience in clinical research and regulatory affairs required • Demonstrated experience with FDA guidance and clinical reviews required • Strong background in clinical trial design, conduct, and data analysis required • Experience evaluating new development opportunities and communicating clear, practical opinions to executive and scientific leadership preferred • Ability to complete required training, including GCP, HIPAA, and company SOP training • Ability to work independently and remotely, with availability for Monday and Wednesday afternoon meetings when possible • Sound judgment and discretion in handling confidential and proprietary information • Successful completion of a background check and drug screening • Signed non-disclosure and at-will employment agreements • Maintain compliance with company policies, HIPAA requirements, and applicable regulatory standards

🏖️ Benefits

• PRN position with a baseline commitment of approximately 5 hours per week • Remote work from a home-office setting • Company-provided or standard office equipment, including computer, telephone, video conferencing, and internet access

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