Senior Medical Writer - 3446783

Senior Medical Writer

We are seeking an experienced Senior Medical Writer with strong expertise in Phase IIII clinical studies and regulatory documentation. This role focuses heavily on authoring Clinical Study Reports (CSRs), protocols, and related clinical documents within biotech, pharma, or CRO environments.

The ideal candidate is a highly experienced hands-on writer who spends the majority of their time developing clinical and regulatory documentation, especially CSRs.

Key Responsibilities

Clinical & Regulatory Writing

• Author and edit:
  • Clinical Protocols & Amendments
  • Informed Consent Forms (ICFs)
  • Clinical Study Reports (CSRs)
• Prepare aggregate safety and efficacy documents:
  • Investigator's Brochures (IBs)
  • DSURs
  • PBRERs
  • Other periodic safety reports
• Support regulatory submissions:
  • eCTD Module 2 & Module 5 documents
  • Briefing books
  • Integrated summaries

Cross-Functional Collaboration

• Lead document planning and timelines
• Manage review/comment adjudication processes
• Facilitate study team and development meetings
• Represent Global Medical Writing in cross-functional discussions
• Build strong partnerships with clinical and regulatory teams

Process & Quality

• Provide peer review support for:
  • Statistical Analysis Plans
  • CRFs
  • Other study materials
• Assist with SOPs, templates, and process improvements
• Ensure compliance with regulatory and internal standards

Required Experience

Medical Writing

• 710+ years of medical/scientific writing experience in pharma, biotech, or CRO environments
• Strong experience authoring:
  • Clinical Study Reports (CSRs)
  • Protocols & Amendments
• Experience with:
  • INDs, BLAs, NDAs
  • PBRERs, DSURs, PAERs
  • Regulatory briefing books preferred
• Advanced knowledge of:
  • AMA/Chicago/CBE style guides
  • MedDRA & WHO Drug dictionaries
  • Clinical data presentation and interpretation

Clinical Development Knowledge

• Strong understanding of:
  • Drug development lifecycle
  • Clinical trial conduct & reporting
  • Safety and efficacy reporting
  • Database management & data integration
• Direct documentation experience across multiple phases of development

Regulatory Expertise

• Familiarity with:
  • eCTD IND/NDA submissions
  • Modules 2, 3, 4 & 5
  • ISS / ISE documentation

Project Management

• Ability to manage multiple priorities and strict timelines
• Experience leading cross-functional review processes
• Strong communication and conflict-management skills

Education

• Bachelor's degree or higher required
• Scientific background preferred
• AMWA certification or related medical writing training is a plus

Technical Skills

Proficiency with:

• Microsoft Word, Excel, PowerPoint
• Adobe Acrobat
• MS Project / Project Server
• Document management systems:
  • Veeva
  • SharePoint
  • LiveLink

Ideal Candidate

• Extremely seasoned Phase IIII clinical medical writer
• Strong focus on:
  • Clinical science
  • CSR authoring excellence
• Must be a primary author, not mainly an editor or project lead
• Candidate should spend 75%+ of time writing CSRs
• Biotech/Pharma experience strongly preferred
• CRO experience acceptable
• Medical device/diagnostic background considered with lower preference