A Global Scientific Communications – CMC Regulatory Associate or Senior Associate is required to join a leading global pharmaceutical business in Cork with Hybrid working. This is a fantastic opportunity to join a diverse and vibrant business that is dedicated to discovering and bringing life-changing medicines to those who need them.

The purpose of the Scientific Communications Associate – CMC Regulatory role is to work with cross-functional, multidisciplinary teams to lead the development of CMC regulatory documents intended for regulatory audiences.

The Role

• Effectively collect and evaluate data, information, and input from multiple sources, functions, and regions to create a cohesive content strategy for writing projects that supports and implements the regulatory submission strategy developed by GRA- scientists.
• Plan (including organizing/preparing outlines), write (including first-draft authoring), edit, review, coordinate and complete the CMC regulatory documents.
• Conduct effective document initiation via a kick-off meeting to ensure authoring team alignment and understanding.
• Build scientific-based rationale that support the purpose of more complex and/or strategic documents.
• Ensure that key data, statements and conclusions are consistent across related documents including module summaries. Ensure that statements and conclusions are integrated, accurate, balanced and supported by appropriate data.
• Coordinate expert/scientific reviews, collate reviewer’s comments, adjust content of document as required based on internal/external input, and prepare final version.

• Bachelor’s degree in a scientific, health, engineering, technology health related field, pharma sciences, chemistry, manufacturing, or other relevant sciences.
• Demonstrated experience in technical/CMC regulatory writing.
• Strong communication and interpersonal skills.
• Successful completion of writing exercise(a writing exercise is required as part of the candidate evaluation process)
• Demonstrated mastery of verbal and written English skills ideally in the medical, scientific, health outcomes, or technical writing fields.
• Experience writing regulatory, CMC regulatory, clinical trial documents and/or technical publications is preferred