Medical Writer

Position Overview

We are seeking a skilled Medical Writer to develop high-quality clinical and regulatory documents in compliance with industry standards and regulatory guidelines.

• Develop clinical & regulatory documents (CSRs, CSPs, IBs, ICFs, CTD Modules, NDAs/BLAs/MAAs).
• Ensure compliance with ICH, GCP, FDA & EMA guidelines.
• Collaborate with Clinical, Regulatory, Biostatistics & Medical Affairs teams.
• Manage multiple projects & timelines.

• Prepare and author clinical and regulatory documents, including but not limited to:
• Clinical Study Protocols (CSPs) and Protocol Amendments.
• Clinical Study Reports (CSRs).
• Investigator's Brochures (IBs).
• Informed Consent Forms (ICFs).
• Common Technical Document (CTD) Modules (e.g., Module 2.5 Clinical Overview, Module 2.7 Clinical Summary).
• Briefing Documents for Regulatory Authorities (e.g., FDA, EMA) Periodic Safety Reports.
• Risk Management Plans (RMPs) and Pediatric Investigation Plans (PIPs).
• New Drug Applications (NDAs), Biologics License Applications (BLAs), and Marketing Authorization Applications (MAAs) and responses to regulatory queries.

• Develop and maintain clinical development plans, clinical trial protocols, and statistical analysis plans.
• Collaborate with clinical teams to ensure alignment of clinical documents with study objectives and regulatory requirements.
• Interpret complex scientific and clinical data and communicate findings clearly and concisely.

• Ensure documents comply with ICH, GCP, FDA, EMA, and other applicable regulatory agency guidelines.
• Maintain up-to-date knowledge of regulatory writing best practices, industry trends, and evolving guidelines.

• Work closely with cross-functional teams, including medical, clinical, regulatory, statistical, and quality assurance teams.
• Review and edit documents prepared by internal teams or external vendors to ensure scientific accuracy, clarity, and compliance.
• Participate in team meetings, regulatory interactions, and strategy discussions.
• Drive document production timelines according to established plans.
• Plan and manage multiple simultaneous document development projects with shifting priorities.