Medical Writer

Experience level: Mid-senior

Experience required: 5 Years

Education level: Doctorate

Job function: Health Care Provider

Industry: Pharmaceuticals

Total position: 1

Relocation assistance: No

Visa sponsorship eligibility: No

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)
    • Investigators 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 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 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 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)
• 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