Offer summary
Qualifications:
6-10 years of regulatory medical writing experience, Extensive medical writing for clinical study documents, Experience with Health Authority responses required, Ability to interpret clinical and scientific data, Strong project management and organizational skills.
Key responsabilities:
- Write and edit clinical submission documents
- Ensure documents meet regulatory standards
- Manage document preparation process and timelines
- Participate in team and client meetings
- Present statistical and medical information clearly