Senior Medical Writer

Role & Responsibilities
• Write, edit, and compile high-quality scientific and regulatory documents across CMC, nonclinical, clinical, medical affairs, and regulatory domains
• Develop documents for regulatory submissions, sponsor use, publications, and presentations
• Lead or contribute to scientific discussions on planning, production, and review of written deliverables
• Perform literature searches and systematic literature reviews as required
• Ensure compliance with global regulatory requirements including US FDA, Health Canada, and EU authorities
• Apply industry best practices and regulatory guidance throughout document development
• Edit, review, and guide documents prepared by junior writers or clients
• Mentor and support less-experienced Medical Writers
• Contribute to development of templates, SOPs, and writing guidelines
• Identify and mitigate project risks related to documentation quality and timelines
• Collaborate with cross-functional project teams and maintain strong client relationships
• Support business development activities including proposal writing and bid defense participation

Qualification
• Bachelor’s degree in a scientific discipline (mandatory)
• Master’s, PhD, PharmD, MD, or equivalent advanced scientific degree strongly preferred

Experience
• Minimum 4+ years of experience in medical writing and regulatory documentation
• Proven experience as lead writer for clinical protocols, CSR, ICFs, narratives, or regulatory submissions
• Hands-on experience with drug, biologic, or medical device development documentation

Skills
• Strong knowledge of US FDA, EU, and Health Canada regulatory requirements
• Excellent scientific writing, editing, and communication skills in English
• High attention to detail with strong quality focus
• Critical thinking and analytical skills
• Client-facing communication and stakeholder management abilities
• Proficiency in MS Word, PowerPoint, Excel, Adobe Acrobat, and web-based collaboration tools

About the Company
• Allucent is a global consulting organization supporting drug, biologic, and device development Works across clinical research, regulatory affairs, and medical writing services.