Job 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

What You Bring

• 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

Who You Are

We're looking for someone who is:

• 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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