Cmc Author

ICON Clinical Research, LP

United Kingdom
Author module 3 ctd documents
Ra specialist cmc knowledge
Global regulatory requirements
ICON plc is a world-leading healthcare intelligence and clinical research organization focused on fostering an inclusive environment driving innovation and excellence

Job Summary

  • ICON plc is a world-leading healthcare intelligence and clinical research organization focused on fostering an inclusive environment driving innovation and excellence.
  • As a Senior Manager, Regulatory Affairs at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
  • ICON offers a range of additional benefits designed to be competitive within each country and focused on well-being and work life balance opportunities for you and your family.

Matching Summary

ICON plc is a world-leading healthcare intelligence and clinical research organization focused on fostering an inclusive environment driving innovation and excellence.

Skills & Requirements

Must-have

  • Author Module 3 CTD documents
  • RA specialist CMC knowledge
  • Global regulatory requirements
  • Drug development stages
  • Pharmaceutical/CRO industry experience
  • Regulatory strategy development

Nice-to-have

  • Peptides and proteins experience
  • Inclusive environment
  • Innovation and excellence
  • Problem-solving ability
  • Interpersonal skills

Key Requirements

  • In-depth proven regulatory affairs expertise
  • Demonstrable experience in regulatory affairs
  • Strong organizational skills
  • Ability to manage multiple tasks
  • Meticulous attention to detail
  • Excellent written, verbal, and management skills
  • Demonstrated presentation skills

Work Rights

Not specified

Tailored Resume

Cover Letter