Senior Medical Writer
Metro Associates
Senior Medical Writer
About the Role
We are seeking an experienced Senior Medical Writer with strong expertise in Phase I-III 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
Medical Writing
Proficiency with:
About the Role
We are seeking an experienced Senior Medical Writer with strong expertise in Phase I-III 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
- 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
- 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
Medical Writing
- 7-10+ 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
- 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
- Familiarity with:
- eCTD IND/NDA submissions
- Modules 2, 3, 4 & 5
- ISS / ISE documentation
- Ability to manage multiple priorities and strict timelines
- Experience leading cross-functional review processes
- Strong communication and conflict-management skills
- Bachelor's degree or higher required
- Scientific background preferred
- AMWA certification or related medical writing training is a plus
Proficiency with:
- Microsoft Word, Excel, PowerPoint
- Adobe Acrobat
- MS Project / Project Server
- Document management systems:
- Veeva
- SharePoint
- LiveLink
- Extremely seasoned Phase I-III 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
Vacancy posted 1 day ago
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