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Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Senior Medical Writer


Reference:SCAIMM-011267 Location: Dublin
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Medical Information, Medical Science Liaison, PhD

Senior Medical Writer
Our client, a biopharma start up are continuing to grow their team and are currently recruiting for a Senior Medical Writer to join their Clinical Science team. As Senior Medical Writer you will report to the Director of Clinical Science. You will work closely with Clinical Operations, Regulatory Affairs and Medical Affairs. This is a key role across the organisation, to contribute to the documentation of the clinical development program and the overall product development. This role will provide you with the opportunity to contribute to the ongoing success of the organisation and to be part of its exciting journey. This is a permanent role offering hybrid working.

Responsibilities:

  • Driving, developing, and writing clinical trial documents, e.g clinical investigation protocols, investigator brochures, monitoring manuals, clinical study reports and clinical summaries
  • Ensuring discussion points and the organisations messaging is conveyed in a consistent scientific manner across documents
  • Generating templates and ensuring alignment across documents
  • Supporting applications to authorities and drafting briefing packages
  • Driving trial team participation in the preparation of such documents, including facilitating meetings, developing and managing timelines, document review, and decisions
  • Updating clinical and non-clinical regulatory documents throughout their lifecycle
  • Overseeing publications of key guidelines within relevant diseases and support internal training
  • Coordinating and supervising outsourced medical writing activities
  • Supporting publications and internal and external training materials
  • Supporting development of communication material
Requirements
  • PhD in life sciences with a minimum of three years’ experience as a post-doc.
  • Experience working as medical writer/scientific writer with the Pharma and Biotech industry for a minimum of five years
  • Solid knowledge on clinical development excellent understanding of ICH GCP and regulatory requirements
  • You have strong knowledge in Neuroscience, preferably within psychiatry, but neurology can be considered
  • Experience authoring clinical components in regulatory filings (NDA, BLA, MAA) highly preferred
  • In-depth knowledge of the structural and content requirements of clinical study reports, protocols, and similar documents and ability to identify deficiencies, errors, and inconsistencies in a protocol or report
  • Strong analytical skills including good understanding of common statistical methods used in clinical trials and interpretation of their results
  • High quality standards and is committed to meet deadlines
  • Excellent written and oral communication skill within medical/science area
  • Solid ability to perform background literature research
  • Thrive in a fast-paced and changing environment
  • Flexible working s with ability to work independently, remotely and in teams
  • Excellent attention to detail
  • Fluent in English
For more information contact Sinéad Cullen on +353879500821 or [email protected]