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!
...Administrative Coordinator I In this challenging role, you will be supporting the SSA - Student Affairs department at Greenville Technical... ...diploma and relevant experience in business management, public administration, or administrative services or a bachelor's degree...
...Furniture AssemblyJoin a manufacturing team building office furniture through assembly, welding, painting, and material handling. We offer 1st and 2nd shift opportunities with overtime available, competitive pay, and room to grow your career in a fast-paced production...
...Identify pipe by size, type, and wall thickness Perform simple rigging operations Install pipe hangers, supports, anchors, and... ...needed.Essential Qualifications Five (5) years minimum Field experience in trade Ability to identify all techniques of welding (TIG,...
...Breakfast Server Serve guests of the Inn a fantastic, cooked to order breakfast! Working as a member of our Food & Beverage Team, ensure that guests have an enjoyable dining experience by providing quality customer service, including accurately taking orders, understanding...
...Assistant / Feeder to support our pressroom operations.In this role, you will work directly... ...with basic press setups, including loading paper, hanging plates, and preparing blankets... ...& Housekeeping: Perform routine, basic machine maintenance and keep the press area clean...