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