Senior Regulatory Medical Writer

A company is looking for a Senior Regulatory Medical Writer (FSP; Remote; US). Key Responsibilities Serve as primary author for FSP clients, writing and providing input on clinical study reports and study protocols Research, write, or edit complex clinical and scientific documents, including IBs, INDs, and MAAs Review documents prepared by junior team members and provide training and mentorship on document preparation Required Qualifications, Training, and Education Bachelor's degree in a scientific discipline or equivalent; advanced degree preferred 5+ years of relevant experience in medical writing, preferably in the pharmaceutical/CRO industry Experience working within Functional Service Provider (FSP) environments preferred Additional qualifications in medical writing (AMWA; EMWA; RAC) are advantageous Equivalency of education, training, and/or directly related experience may be considered

Apr 17, 2025 - 04:21

A company is looking for a Senior Regulatory Medical Writer (FSP; Remote; US). Key Responsibilities Serve as primary author for FSP clients, writing and providing input on clinical study reports and study protocols Research, write, or edit complex clinical and scientific documents, including IBs, INDs, and MAAs Review documents prepared by junior team members and provide training and mentorship on document preparation Required Qualifications, Training, and Education Bachelor's degree in a scientific discipline or equivalent; advanced degree preferred 5+ years of relevant experience in medical writing, preferably in the pharmaceutical/CRO industry Experience working within Functional Service Provider (FSP) environments preferred Additional qualifications in medical writing (AMWA; EMWA; RAC) are advantageous Equivalency of education, training, and/or directly related experience may be considered