Our client, a global pharma company based in Cork, is currently recruiting for a Medical Writer to join their team. As medical writer, you will work with cross functional, multidisciplinary teams to facilitate external scientific publications such as abstracts, posters, manuscripts and presentations, and regulatory documents such as , protocols, clinical study reports, briefing documents, regulatory responses, and marketing authorization applications. This is a contract role with hybrid working.


Responsibilities

• Plan, write, edit, review, and coordinate the publication of scientific data through peer reviewed journals and forums and/or regulatory documents
• Facilitate trial development and product registration
• Ensure and coordinate quality checks for accuracy, collate reviewer’s comments, adjust content of document as required based on internal/external input, and prepare final version
• Ensure final documents and supporting quality check documentation (with all signatures where appropriate) are placed in appropriate document management system
• Build / relationships with vendors / alliance partners
• Maintain and enhance therapeutic area knowledge including, disease state and compound for assigned project
• Possess overarching view of compound, therapeutic area, and external environment (including competitors) with ability to lead the scientific data disclosure planning, clinical planning, submission strategy planning, customer regulatory responses, and/or current awareness literature updates and reviews

• PhD is preferred but candidates with Bachelor’s Degree will be considered
• Graduate degree with formal research component or in life sciences
• Clinical pharmacology, therapeutic area, or other medical and scientific specific knowledge and experience (e.g., neuroscience, oncology, cardiovascular, or endocrine expertise)
• Experience in clinical trial process or regulatory activities is preferred
• Experience writing regulatory or clinical trial documents is preferred
• Publication experience
• Demonstrated mastery of written English with experience in medical, scientific or technical writing fields (at least 1 year); professional verbal skills in English