Senior Medical Writer
BeOne Medicines
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $101,700 - $136,700 per year
Job Level
About the role
- Responsible for writing, editing, and formatting clinical regulatory documents
- Ensure documents conform to regulatory submission and internal document standards
- Collaborate effectively with cross-functional groups
- Manage timelines and communicate with team members
- Review and edit documents authored by others
- Develop and maintain medical writing processes, standards and tools
Requirements
- 4 years' relevant industry experience as a regulatory medical writer
- BA/BS degree; PhD/PharmD in life sciences preferred
- Strong project management skills
- Experience in writing regulatory documents such as clinical study reports, protocols, and protocol amendments
- Keen understanding of FDA and ICH guidelines
- Technical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems
- Proficiency in Microsoft Outlook, Excel and PowerPoint
Benefits
- Medical
- Dental
- Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory writingclinical study reportsprotocolsprotocol amendmentsproject managementdocument formattingeditingmedical writing processesFDA guidelinesICH guidelines
Soft skills
collaborationcommunicationtime management