- Provide expertise supporting development of clinical and regulatory documents for products in BeOne’s pipeline
- Support documents through development, submission, approval, and life-cycle management
- Write clinical study protocols, investigator brochures, clinical study reports, and clinical modules of IND submissions
- Manage assigned writing tasks and ensure compliance with regulatory guidelines and company standards
- Manage multiple complex documents in collaboration with cross-functional and study teams
- Contribute to document development direction and strategy
- Provide feedback on writing templates and guidance
- Develop and manage timelines and resolve document risks and issues
- Build connections with study teams
- Identify process and tool optimization opportunities
- Participate in and provide feedback on training programs
- Guide study teams within defined medical writing scope and responsibilities
- Provide insight on global medical writing deliverables and related departmental knowledge
- Provide mentoring and feedback to team members
Requirements
- An advanced degree (MS/PhD/PharmD/MD) in life science, pharmacy, medical, or health-related science by July 2027
- Curriculum vitae (CV), letter of intent, and unofficial college transcript required when applying
- Ability to manage assigned writing tasks and ensure adherence to regulatory guidelines, BeOne SOP/WIs, templates, and style guides
- Ability to manage multiple complex documents, urgent timelines, and external collaboration
- Ability to critically analyze, synthesize, and present complex information
- Ability to develop and manage document timelines and identify risks, issues, and resolutions
- Ability to communicate clearly and escalated questions/issues appropriately
- Microsoft Word and Adobe Acrobat technical expertise
- Proficiency in Microsoft Outlook, Excel, and PowerPoint
- Occasional travel as needed
Core Competencies
Demonstrates expertise in clinical and regulatory document development, including writing clinical study protocols and IND submissions, while ensuring compliance with regulatory guidelines. Capable of managing complex documents and timelines, providing mentorship, and optimizing processes within cross-functional teams.
Highest-signal resume keywords
- Clinical Study Protocol Writing
- Regulatory Document Management
- Microsoft Word Expertise
- Document Timeline Management
- Advanced Degree in Life Science
Hard Skills
- Clinical Study Report Writing
- IND Submission Development
- Document Risk Identification
- Critical Analysis and Synthesis
- Document Compliance Management
Soft Skills
- Clear Communication
- Mentoring and Feedback
- Collaboration with Study Teams
- Problem-Solving
Industry Keywords
- Life Science
- Pharmacy
- Health-Related Science
- Regulatory Guidelines
- SOP/WIs
Tools & Technologies
- Microsoft Outlook
- Microsoft Excel
- Microsoft PowerPoint
- Adobe Acrobat
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Medical Writing Fellow Arbeitgeber: Jobtailor
Als Front Office Supervisor in unserem dynamischen Team bieten wir Ihnen die Möglichkeit, in einem unterstützenden und freundlichen Arbeitsumfeld zu wachsen. Wir legen großen Wert auf die berufliche Entwicklung unserer Mitarbeiter und bieten regelmäßige Schulungen sowie die Chance, Verantwortung zu übernehmen. Unsere Lage ermöglicht es Ihnen, Teil einer lebendigen Gemeinschaft zu sein, während Sie gleichzeitig die Standards unseres Franchise-Partners einhalten und unseren Gästen einen unvergesslichen Aufenthalt bieten.
