Job Description
- 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
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