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Senior Principal Medical Writer
BeOne MedicinesSenior Principal Medical Writer at BeOne providing regulatory writing expertise for oncology drug development. Leading document management and mentoring Medical Writers in a remote setting.
About the role
Key responsibilities & impact- Responsible for providing expertise to support the development of clinical and regulatory documents
- Mentor Medical Writers as needed
- Manage document writing tasks and ensure compliance with regulatory guidelines
- Navigate through uncertainties to manage timelines for multiple documents
- Identify risks and develop mitigation plans
- Contribute to process/tool optimization and establishment
- Lead training programs and mentorship for Medical Writers
Requirements
What you’ll need- Advanced degree (MS/PhD/PharmD/MD) in life science, pharmacy, medical, or health-related science preferred
- BS with a minimum of 7 years of regulatory document writing experience, Masters with 5+, or PhD/PharmD/MD with 3+ years of regulatory document writing experience
- Technical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems
- Proficiency in Microsoft Outlook, Excel, and PowerPoint
Benefits
Comp & perks- Medical
- Dental
- Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
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Hard Skills & Tools
regulatory document writingdocument writing tasksprocess optimizationrisk identificationmitigation plans
Soft Skills
mentorshiptraining programscommunicationleadershiporganizational skills
Certifications
advanced degreeMSPhDPharmDMD