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Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Scientific Writer Regulatory


Reference:SCA015095 Location: Cork
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: PhD, Regulatory Affairs, Regulatory Affairs Executive, Regulatory Affairs Officer, Regulatory Affairs Specialist, Scientist

Scientific Writer Regulatory
Our client, a global pharma company, are currently growing their Global Scientific Communications team and are currently seeking a skilled Scientific Writer Regulatory to join their team on a permanent basis. As Scientific Writer Regulatory you will be responsible for the creation of high-quality regulatory documents (e.g., clinical study reports, briefing packages, regulatory responses, IND/MAA submissions). The role involves collaborating with cross-functional teams to ensure clear, accurate, and compliant scientific content throughout the drug development lifecycle. This role offers hybrid working.

Responsibilities:

  • Document Development: Plan, write, edit, and finalize regulatory documents; ensure data accuracy, clarity, and consistency; coordinate reviews and incorporate feedback.
  • Project Management: Develop timelines, manage risks, track progress, and maintain communication with stakeholders to deliver on schedule.
  • Scientific Expertise: Maintain up-to-date knowledge of assigned therapeutic areas, compounds, and relevant regulatory guidelines.
  • Collaboration & Coaching: Share best practices, provide guidance to colleagues, and contribute to process improvements.
Requirements:
  • Bachelor’s degree in life sciences, health, communications, or related field.
  • Advanced degree with research background.
  • Expertise in relevant therapeutic areas (e.g., oncology, neuroscience, immunology)
  • Experience with clinical development and regulatory submissions
  • Proven experience in regulatory or technical scientific writing
  • Strong communication, interpersonal, and project management skills
  • Proficiency with document management systems and standard software tools
For more information please contact Sinéad Cullen on +353879500821 or [email protected]