Consultant I, Medical Writing
Remote
RemoteFull TimeMedium
Full TimeMedium
Job Summary
Author clinical study reports, study protocols, and client submission materials while leading complex module development for orphan drug and fast-track applications. Manage regulatory projects as a project owner by tracking timelines, anticipating challenges, and coordinating with cross-functional teams to ensure submission readiness. Facilitate client interactions and feedback discussions to maintain trust while applying quality control processes to deliver high-quality documents within agreed deadlines. Contribute to early-stage regulatory strategies and provide guidance on document management systems and client SOPs under senior mentorship.
Required Qualifications
- 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
- Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time
Desired Qualifications
- An advanced degree (e.g., M.S., PharmD, Ph.D., or M.D.) in life or health science is preferred
- RAC certification is beneficial
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