Consultant I, Medical Writing

Overview

The MWS Consultant I authors and manages regulatory documents, supports client regulatory strategies, and ensures high-quality deliverables that align with client expectations and regulatory standards.

What you'll do

• Author a variety of regulatory documents, including Clinical Study Reports (CSRs), study protocols, and client submission materials.
• Lead the development of complex modules (e.g., Module 2 summaries, Briefing Documents, Orphan Drug, Fast-Track, and Breakthrough Designation applications).
• Apply quality control and submission-readiness processes to deliver high-quality documents within agreed client timelines.
• Serve as a project owner by tracking timelines, adjusting schedules, and coordinating with clients to address evolving demands.
• Plan for and anticipate project challenges, update visual timelines, and maintain adherence to deadlines.
• Facilitate client interactions, including meetings, inquiries, and feedback discussions, while building and maintaining client trust.
• Ensure consistency, accuracy, and alignment across documents with client updates and applicable regulatory standards.
• Collaborate with cross-functional teams to ensure the quality and accuracy of regulatory documents.
• Contribute to the development of regulatory strategies for early-stage and smaller clients.
• Provide guidance on tools, document management systems, and client SOPs.
• Engage in continuous learning through exposure to new document types, processes, and industry best practices under senior mentorship.

What you'll need

• 3+ years industry experience
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Teams, and MS Project
• Familiarity with regulatory document management systems, such as Veeva Vault
• Experience with regulatory submissions and understanding of global regulatory standards
• Strong foundation in medical writing, regulatory writing, and interpretation of scientific content
• Knowledge of pharmaceutical and biopharmaceutical environments, including clinical trials and regulatory submissions
• Effective written and verbal communication skills, with the ability to communicate complex scientific and regulatory information clearly and concisely
• Exceptional project and time management skills, with the ability to prioritize multiple projects and adjust timelines proactively
• Patient and empathetic approach, especially in cross-cultural and client-facing environments
• Positive attitude toward feedback and a willingness to apply it for continuous improvement
• Strong critical thinking and data analysis skills to ensure scientific claims align with evidence and regulatory requirements
• High attention to detail, ensuring alignment and accuracy across multiple document reviews

Nice to have

• An advanced degree (e.g., M.S., PharmD, Ph.D., or M.D.) in life or health science
• RAC certification

Details

• Work location: eligible for remote work based on company requirements, with no minimum in-office requirement
• Physical demands: regularly use a computer keyboard and mouse, reach, talk and listen; frequently walk and sit; lift and carry objects up to 25 pounds; occasionally stand, stoop or kneel; close vision and ability to adjust focus
• Work environment: moderate noise level, indoor temperate environment, bright light conducive to minimal eye strain, typical office environment