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Details

Regulatory Scientific Communications Associate


Reference:A007312 Location: Cork
Qualification:DegreeExperience:See description
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Nurse Associate, Regulatory Affairs

Our client, a global pharmaceutical organisation are currently recruiting for a Scientific Communications Associate to join their newly created Global Scientific Communications team. As Regulatory Scientific Communications Associate you will work with cross-functional, multidisciplinary teams to lead the development of documents intended for regulatory audiences including, clinical study reports, briefing documents, regulatory responses, Investigational New Drug Applications, and marketing authorization applications.


Responsibilities

  • Document Preparation, Development and Finalization/Document Management
  • Effectively collect and evaluate data, information, and input from multiple sources, functions, and regions to create a cohesive content strategy for writing projects
  • Plan (including organizing/preparing outlines), write (including first-draft authoring), edit, review, coordinate, and complete the regulatory documents supporting clinical development/product registration
  • Conduct effective document initiation meeting to ensure authoring team alignment and understanding
  • Build scientific-based rationale that support the purpose of more complex and/or strategic documents
  • Ensure data are presented in a clear, complete, accurate, and concise manner
  • Ensure that key data, statements and conclusions are consistent across related documents, and 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
  • Ensure and coordinate quality checks for accuracy
  • Exhibit flexibility in moving across development and preparation of multiple document types
  • Influence or negotiate change of timelines and content with other team members
  • Work with internal and external experts to develop and prepare presentations
  • Lead the writing process and apply effective project management skills to ensure timely completion of high-quality regulatory documents
  • Build/communicate credible writing project timelines
  • Anticipate and mitigate risks to delivery
  • Work with teams and stakeholders to ensure smooth and timely development of documents and escalate issues, as appropriate, to ensure document completion
  • Maintain and enhance therapeutic area knowledge including disease state and compound(s) for assigned project(s)
  • Maintain and enhance knowledge of regulatory guidelines and publication guidelines
  • Possess overarching view of compound, therapeutic area, and external environment (including competitors) with ability to participate effectively in clinical planning, submission strategy planning, customer regulatory responses, and/or current awareness literature updates and reviews


Requirements

  • Bachelor’s degree in a scientific, health, communications, technology health related field
  • Demonstrated experience in technical/ regulatory scientific writing
  • Strong communication and interpersonal skills
  • Successful completion of writing exercise (a writing exercise is required as part of the candidate evaluation process
  • Graduate degree with formal research component or in life sciences
  • Demonstrated mastery of verbal and written English skills in the medical, scientific or technical writing fields
  • Clinical pharmacology, therapeutic area, or other medical and scientific specific knowledge and experience specific to hiring area (e.g., neuroscience, oncology, cardiovascular, immunology or endocrine expertise)
  • Experience writing regulatory, clinical trial documents and/or publications
  • Experience in clinical development, clinical trial process or regulatory activities
  • Demonstrated project management and time management skills
  • Demonstrated high-level end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentation and templates)