Senior Manager, Medical Writer

Overview

We are seeking a skilled Medical Writer to develop high-quality clinical and regulatory documents in compliance with industry standards and regulatory guidelines. The ideal candidate will collaborate with cross-functional teams, including Clinical, Regulatory, Biostatistics, and Medical Affairs, to create well-structured, scientifically accurate, and regulatory-compliant documents.

Responsibilities

Under leadership support:

• Regulatory Document Writing:
  • 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, MFDS)
    • Periodic Safety Reports
    • Risk Management Plans (RMPs), Pediatric Investigation Plans (PIPs), and Orphan Drug Designation Requests
    • Initial Drug Applications (INDs), New Drug Applications (NDAs), Biologics License Applications (BLAs), and Marketing Authorization Applications (MAAs)
    • Responses to regulatory queries
• Clinical Development Support:
  • 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
• Regulatory Compliance & Standards:
  • 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
• Collaboration & Review:
  • • • Work closely with cross-functional teams, including medical, clinical, regulatory, statistical, pharmacovigilance 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

Qualifications

• Advanced degree (PhD, PharmD, MD, or MSc) in Life Sciences, Medicine, Pharmacy, or a related field
• Minimum 3 years of medical writing experience in the pharmaceutical, biotech, or CRO industry
• Strong background in writing regulatory documents for clinical trials and submissions
• Epilepsy or Neurology experience is a plus
• Experience with drug development across different phases (Phase I-IV) is a plus
• Strong understanding of the drug development process, clinical research concepts, clinical study conduct, clinical study data collection, regulatory requirements, and biostatistical concepts
• Familiarity with medical terminology and ability to interpret complex clinical data
• Strong understanding of the concepts of coding dictionaries (MedDRA, WHODrug, etc.)
• Excellent scientific writing, editing, and document structuring skills
• Ability to simplify complex scientific concepts for diverse audiences
• Proficiency in ICH guidelines, GCP, and regulatory submission requirements (FDA, EMA, etc.)
• Strong attention to detail, ability to manage multiple projects, and meet deadlines
• Ability to work independently and collaboratively in a fast-paced environment
• High level of Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
• Experience with document management systems and publishing tools (e.g., EndNote, Adobe Acrobat, regulatory submission platforms)