Job Description
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
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