Consultant I, Medical Writing
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Job Description
MWS Consultant I authoring regulatory documents, leading projects, and building client relationships at Syner-G. Requires advanced degree and 3 years of experience in medical writing and regulatory compliance.
Responsibilities:
- 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.
Requirements:
- An advanced degree (e.g., M.S., PharmD, Ph.D., or M.D.) in life or health science is preferred.
- RAC certification is beneficial.
- 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.
Benefits:
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Professional development opportunities
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