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Regulatory - Global Scientific Communications

Reference:AORAGUS-170347
Location: Cork
Cork City
Qualification:Doctorate
Experience:0-1 Years
Job Type:Permanent
Salary:Not Disclosed
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May be suitable for: Regulatory Affairs

Associate / Sr. Associate - Regulatory - Global Scientific Communications

Start Date: May
Location: Cork
50% remote, 50% onsite

Purpose:
Scientific data and information are core assets of the company. Providing balanced, objective, and accurate information to regulators, the scientific community, health care professionals, payers, and patients in a consistent and timely fashion across the entire drug development lifecycle is fundamental to the organisation.

The purpose of the Scientific Communications Associate - Regulatory role is to work with cross-functional, multidisciplinary teams to lead the development of documents intended for regulatory audiences (including, but not limited to, clinical study reports, briefing documents, regulatory responses, Investigational New Drug Applications, and marketing authorization applications).

Core Objectives

  • The day-to-day structure of the regulatory role is primarily project management focused, with a balance of 50% writing and 50% project management responsibilities.
  • It is essential for the candidate to possess strong project management skills, as the role is deadline-driven and requires the ability to understand the bigger picture while being personable and approachable.
  • Effective communication and the ability to influence others without formal authority.
  • Candidates should be adapt at structuring their writing effectively and adhering to specific rules and guidelines.
  • Content Strategy and Execution: Document Preparation, Development and Finalization/Document Management
  • Project and Stakeholder management
  • Share knowledge and continue to develop your skills
Minimum Qualification Requirements:
  • PhD in a scientific, health, communications, technology health related field.
  • Demonstrated experience in technical/ regulatory scientific writing.
Other Information/Additional Preferences:
  • Graduate degree with formal research component or in life sciences.
  • 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.
For further information contact Alan on [email protected] or via phone at +353 87 3657522



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