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Principal Regulatory Medical Communications Expert

2 weeks ago

Dublin, Dublin City, Ireland beBee Careers Full time

The Position:

We are looking for a highly skilled Principal Regulatory Medical Communications Expert to join our team. As a Regulatory Medical Writer, you will be responsible for creating high-quality communications that meet regulatory standards.

Key Responsibilities:

  • Mentor and lead less experienced medical writers on complex projects.
  • Stay up-to-date with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables.
  • Review and finalize statistical analysis plans and table/figure/listing specifications.
  • Provide expert feedback on draft and final documents.
  • Ensure compliance with established regulatory standards and industry practices.
  • Communicate changes to medical writing leadership and stakeholders.

Requirements:

  • Bachelor of Science degree or Bachelor of Arts degree in Social Sciences, English, or Communications with relevant scientific and/or medical knowledge.
  • Familiarity with FDA and ICH regulations and guidelines as well as AMA style guide.
  • Excellent leadership, presentation, and communication skills.
  • Proficiency in Word, Excel, PowerPoint, and Internet.
  • Able to interpret and present complex clinical data.