Consultant I, Medical Writing

Remote role Full-time Open position

Job Description:

The MWS Consultant I plays a critical role in authoring and managing regulatory documents, supporting client regulatory strategies, and ensuring high-quality deliverables that align with client expectations and regulatory standards.
This role is responsible for leading document development efforts, coordinating regulatory projects, and collaborating with cross‑functional teams to meet diverse client needs across varying stages of development.
The MWS Consultant serves as both a technical contributor and project owner, ensuring document accuracy, submission readiness, and adherence to regulatory requirements while maintaining strong client relationships and delivery excellence.

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.
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.

Benefits:

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