[Hiring] Senior/Principal Medical Writer @Eldridge Writing & Consulting LLC

Role Description We're looking for a Senior or Principal Medical Writer who combines strong scientific judgment with a proactive, service-oriented mindset. This is a lead authorship role embedded within an interconnected, high-performing writing team — you'll bring strategic influence and deep submission expertise while collaborating closely with colleagues, clients, and cross-functional partners to drive documents from planning through submission. What You'll Do • Document authorship • Serve as lead author on a range of submission-ready regulatory and clinical documents, including: • CSRs • Protocols • Investigator's brochures • Briefing documents • NDA/BLA submission documents, including CTD Modules 2 • Integrated summaries • Strategy and execution • Interpret and synthesize clinical data into clear, accurate, and compelling narratives, with an eye toward fixing issues before they affect downstream deliverables • Provide strategic input on document planning, content, and messaging • Anticipate client milestone deliverables based on development status, identify all necessary project inputs, and propose efficient pathways to meet client goals • Anticipate roadblocks and scenario plan proactively to protect timelines • Format and QC submission-ready documents aligned with client and regulatory preferences • Strategically review and edit documents prepared by colleagues • Client and project management • Collaborate directly with clients and cross-functional teams to ensure clarity, consistency, and compliance across all written materials • Independently prepare for and lead adjudication meetings • Manage multiple projects simultaneously with minimal oversight, balancing timelines, quality, and client expectations • Demonstrate flexibility, reliability, and clear communication — internally and externally — to consistently exceed client expectations • Team and company contribution • Contribute to internal training, process improvements, and knowledge-sharing initiatives • Mentor colleagues and uphold team quality standards • Uphold and embody company core values: excellence, agility, ingenuity, servant leadership, and passion Qualifications • Advanced degree (MS, PhD, PharmD, MD, or equivalent) preferred • Substantial regulatory medical writing experience, including submissions • Comfort and credibility in client-facing settings • Solid command of ICH guidelines and global regulatory expectations • Excellent analytical, writing, and editing skills Requirements • Accountable — you own your work, follow through, and can be counted on • Flexible — you understand every project and team is unique, and you adapt easily • Detail-oriented — you operate with precision and accuracy • Collaborative — you're a problem solver and make the team stronger • Service-minded — you genuinely care about client outcomes and go above and beyond to deliver excellent service Apply tot his job Apply To this Job