Medical Writer

SUMMARY OF POSITION:

• 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.

KEY RESPONSIBILITIES:

• 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)
    • 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)
    • 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, Google Cloud Platform, 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, 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

QUALIFICATIONS:

• Advanced degree (PhD, PharmD, MD, or MSc) in Life Sciences, Medicine, Pharmacy, or a related field.
• Minimum 3-5 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, Google Cloud Platform, 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)
• Veeva experience

PHYSICAL AND MENTAL REQUIREMENTS:

• Ability to multitask
• Maintain composure under pressure
• Ability to follow verbal or written instructions and use of effective verbal communications
• Adapts and adjusts to change and grasps information quickly
• Detail-oriented

OTHER:

• Must have excellent, concise, and clear written and oral communication skills; possess strong analytical and interpersonal skills, ability to work independently.
• Highly motivated self-starter with a positive attitude, possessing the initiative required to achieve desired goals both independently and within a team structure.
• Demonstrated project management ability.
• Excellent interpersonal, oral and written communication skills.
• Strong relationship-building skills.
• Team-oriented, with the ability to work effectively with others