Consultant I, Medical Writing
Job Description:
• Author a variety of regulatory documents including Clinical Study Reports (CSRs), study protocols, and client submission materials.
• Lead the development of complex regulatory modules such as Module 2 summaries, Briefing Documents, and Orphan Drug, Fast Track, and Breakthrough Designation applications.
• Ensure consistency, accuracy, and alignment across documents with client updates and applicable regulatory standards.
• 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 project 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.
• Support early‑stage and smaller clients by contributing to regulatory strategy development.
• Collaborate with cross‑functional teams to ensure the quality and accuracy of regulatory deliverables.
• 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:
• Advanced degree in a life or health science discipline (e.g., M.S., PharmD, Ph.D., or M.D.) preferred.
• RAC certification beneficial.
• Strong foundation in medical writing, regulatory writing, and interpretation of scientific content.
• Ability to communicate complex scientific and regulatory information clearly and concisely, both in writing and verbally.
• Exceptional project and time management skills with the ability to manage multiple priorities and proactively adjust timelines.
• Strong critical thinking and data analysis skills to ensure scientific claims align with supporting evidence and regulatory expectations.
• High attention to detail with the ability to ensure consistency and accuracy across multiple document reviews.
• Patient and empathetic approach, particularly in cross‑cultural and client‑facing environments.
• Positive attitude toward feedback and continuous improvement.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Microsoft Teams, and MS Project.
• Familiarity with regulatory document management systems such as Veeva Vault.
• Knowledge of pharmaceutical and biopharmaceutical environments, including clinical trials and regulatory submissions.
• Experience with regulatory submissions and an understanding of global regulatory standards.
Benefits:
• robust benefit offerings
• ongoing recognition and career development opportunities
• generous flexible paid time off program
• company paid holidays
• flexible working hours
• fully remote or hybrid work options
Apply tot his job
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• Author a variety of regulatory documents including Clinical Study Reports (CSRs), study protocols, and client submission materials.
• Lead the development of complex regulatory modules such as Module 2 summaries, Briefing Documents, and Orphan Drug, Fast Track, and Breakthrough Designation applications.
• Ensure consistency, accuracy, and alignment across documents with client updates and applicable regulatory standards.
• 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 project 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.
• Support early‑stage and smaller clients by contributing to regulatory strategy development.
• Collaborate with cross‑functional teams to ensure the quality and accuracy of regulatory deliverables.
• 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:
• Advanced degree in a life or health science discipline (e.g., M.S., PharmD, Ph.D., or M.D.) preferred.
• RAC certification beneficial.
• Strong foundation in medical writing, regulatory writing, and interpretation of scientific content.
• Ability to communicate complex scientific and regulatory information clearly and concisely, both in writing and verbally.
• Exceptional project and time management skills with the ability to manage multiple priorities and proactively adjust timelines.
• Strong critical thinking and data analysis skills to ensure scientific claims align with supporting evidence and regulatory expectations.
• High attention to detail with the ability to ensure consistency and accuracy across multiple document reviews.
• Patient and empathetic approach, particularly in cross‑cultural and client‑facing environments.
• Positive attitude toward feedback and continuous improvement.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Microsoft Teams, and MS Project.
• Familiarity with regulatory document management systems such as Veeva Vault.
• Knowledge of pharmaceutical and biopharmaceutical environments, including clinical trials and regulatory submissions.
• Experience with regulatory submissions and an understanding of global regulatory standards.
Benefits:
• robust benefit offerings
• ongoing recognition and career development opportunities
• generous flexible paid time off program
• company paid holidays
• flexible working hours
• fully remote or hybrid work options
Apply tot his job
Apply To this Job