Consultant I, Medical Writing

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:

• Competitive salary
• Flexible working hours
• Professional development budget
• Home office setup allowance
• Global team events

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