Senior/Principal Medical Writer Job at Eldridge Writing & Consulting LLC, Remote

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  • Eldridge Writing & Consulting LLC
  • Remote

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 

Job Tags

Remote job, Full time, Flexible hours

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