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 let's make work better!
...After-school support person near 51201 needed to assist with various activities, provide guidance and monitor student behavior during after-school hours. Flexible schedule and ability to work well with youth essential. Previous experience working with students preferred...
Class B Local Class B Driver - 4 Day Work Week JobWorking as a Full-Time Driver (DOT-Class B CDL), you will be representing the Fastenal fleet... ...(***) ***-**** Tell em' Gary's Job Board sent you.This truck driving job may have an alternate application method. Look...
...Company Description Job Location: Fargo, ND Are you a civil engineering or survey technician student looking for an internship... ...leading-edge science-based solutions to public, private and non-profit clients. Consider joining our team as a Survey intern...
Target is seeking an Executive Team Leader to drive guest-first service and store performance in a dynamic retail environment. You will set staffing plans, coach leaders, and ensure training and development align with business goals.You will lead hourly teams, monitor...
...CDL-A Local Live Haul Driver Good Pay + Bonus | Home Daily Earn $80,000 per... ...trailers Average 3-4 inbound loads per day Approximately 15-20 stops per week... ...Automatic and manual day cabs Flatbed trailers Trucks cannot be taken home Load securement...