Senior Medical Writer

BioPhase Solutions specializes in recruiting top talented professionals for the San Diego County Scientific community. We are currently looking for a REMOTE Associate Director Medical Writer to work for a leading San Diego biotech company. Responsibilities • Partner cross-functionally with Clinical Development, Biostatistics, and Regulatory teams to translate complex data into clear, high-quality regulatory documents • Lead and/or contribute to the preparation of clinical and regulatory deliverables, including CSRs, IBs, protocols, briefing documents, and Module 2 summaries • Drive consistency in messaging, structure, and scientific accuracy across documents, including facilitating data interpretation and review discussions • Oversee and/or support document timelines, ensuring efficient review cycles, comment resolution, and on-time submission readiness • Ensure all deliverables align with global regulatory standards (FDA, EMA, ICH), including QC review and collaboration with QA and Regulatory Operations • Contribute to regulatory submissions (IND/NDA), including supporting responses to health authority inquiries Requirements • At least 10+ years of medical writing experience within sponsor pharma or biotech • Advanced degree required • Demonstrated experience developing regulatory documents, with strong exposure to CSRs and IBs • Extensive experience with owning, contributing to or supporting NDA regulatory submissions • Background in small molecule drug development required • Working knowledge of FDA, EMA, and ICH guidelines (including ICH E3 and E6) • Strong ability to interpret scientific data and communicate it clearly in a regulatory context • Proven ability to manage multiple deliverables and collaborate effectively in a fast-paced environment • Proficiency in Microsoft Office and Adobe; familiarity with Veeva or eCTD systems is a plus • Ability to work remotely while aligning with West Coast hours, with occasional travel as needed What we offer: As we work to develop innovations that take care of others, we also work to care for our teammates’ professional and personal growth and well-being. · Full support and career-development resources to help you reach your potential · A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act Apply now and lets make work better!