Overview Aroga Biosciences is an award-winning Contract Research Organization (CRO) based in San Diego, CA. We specialize in providing regulatory writing and submission services for biotech and pharmaceutical projects. Our team has extensive regulatory and medical writing experience across therapeutic areas, and we are committed to delivering high-quality deliverables while maintaining flexibility and adherence to regulatory standards. Role Description This is a full-time hybrid role for a Regulatory Medical Writer (levels up to Director). The Regulatory Medical Writer will develop high-quality regulatory documents (e.g., clinical study reports, clinical protocols, and Investigator’s Brochures). The position requires collaboration with cross-functional teams, reviewing and interpreting data, and ensuring compliance with regulatory guidelines. While primarily based in San Diego, CA, there is flexibility for some remote work. Responsibilities Develop regulatory documents such as clinical study reports, clinical protocols, and Investigator's Brochures. Collaborate with cross-functional teams and interpret data to ensure regulatory compliance. Review and interpret data, ensuring adherence to regulatory guidelines and requirements. Qualifications Master’s or doctoral degree (M.S., Ph.D., Pharm.D, M.D., or equivalent) Scientific Writing, Medical Communications, and/or Medical Writing experience Experience writing and reviewing regulatory documents Strong research and analytical skills Excellent written and verbal communication skills Attention to detail and ability to meet tight deadlines Knowledge of regulatory guidelines and requirements Experience in the biotech or pharmaceutical industry is a plus Senior-level candidates should have management/mentorship experience Benefits and Perks Competitive salary; salary and position commensurate with experience Comprehensive medical, dental, and vision insurance Flexible work week Hybrid schedule – onsite with option to work remotely on Mon and Fri Remote employment may be considered with 10% travel 401(k) options Location San Diego, CA Seniority level Mid-Senior level Employment type Full-time Job function Regulatory Writing and Medical Writing #J-18808-Ljbffr Aroga Biosciences
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