The role
Med Communications needs a senior regulatory writer to lead documents for investigational and marketed products and manage several client projects at once. You'll work with cross-functional teams across Europe.
What you'll do
- Lead writing of protocols, CSRs, briefing books, INDs and NDAs
- Manage timelines and communications for at least three concurrent projects
- Run document review meetings and resolve conflicting feedback from experts
- Quality-control documents and contribute to peer reviews
- Help improve SOPs and mentor less experienced writers
What they're looking for
- 2+ years (typically 3-5) of regulatory or medical writing in pharma
- Mastery of three or more regulatory document types
- Ability to apply regulatory guidelines to content
- Strong attention to detail and written and verbal communication
- Proficiency in Word, Excel, PowerPoint and Outlook
Skills and platforms
- Regulatory writing
- Medical writing
- Protocol development
- Clinical study reports
- IND preparation
- NDA preparation
- Regulatory compliance
- Project management
- Cross-functional collaboration
- Quality control
- SOP development
- Mentoring
- Microsoft Word
- Microsoft Excel
- Microsoft PowerPoint
- Microsoft Outlook
The company
Med Communications
Business Consulting and Services
Med Communications is a trusted global provider of medical affairs services to the life sciences industry specializing in medical information contact centers, scientific communications and…
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