The Role
Working on a number of exciting projects and with an exciting pipeline, the Principal Medical Writer (Regulatory) will be responsible for;
1. Writing, editing, and reviewing documents such as Clinical Study Report, Protocols, Informed Consent, Safety Aggregate Reports (DSUR/PBRER), Safety Narratives, Clinical summaries / CTD sections to Clinical Overviews etc and more
2. Managing multiple projects concurrently, taking the lead on projects
3. Mentoring junior members of the team
4. Reviewing all documentation to a high standard
5. Working across multiple therapy areas
6. Meet both internal/external deliverables against set timelines
You
To apply for this role as Principal Medical Writer (Regulatory / Clinical) our client is hoping for someone with the following skills and experience;
7. Ample experience in a Medical Writing / Regulatory Writing role
8. Experienced within a CRO or Pharma setting
9. Experienced writing, editing, and reviewing documents such as Clinical Study Report, Protocols, Informed Consent, Safety Aggregate Reports (DSUR/PBRER), Safety Narratives, Clinical summaries / CTD sections to Clinical Overviews
10. Can work in a fast-paced environment, meeting internal and external deliverables
11. Can manage multiple projects at once
12. Mentoring experience
13. Project lead experience