Reporting to the Director of Medical Communications, the person will be responsible for analysing, and interpreting scientific data to reach conclusions, in addition to writing and preparing Regulatory documents.
Company and Role
Based in the US, this full service CRO are looking for an experienced Medical writer to work on project based work including protocol writing for clinical trials.
- Writing of clinical Documents including protocols, IBs and CSRs
- Writing of Regulatory documents including IND and eCTD/NDA documents and regulatory agency meeting briefing books.
- Preparing of regulatory presentations, including FDA/TGA advisory committee slide presentations
- Analysing and interpreting nonclinical and clinical study data
- You will be utterly creative across every project and ensure that client briefs are strategically matched
- Your writing will be adaptable dependent on audience and project specifications
- 5+ years’ experience related to clinical research and protocol wirting
- Ability to negotiate scientific language
- A strategic planner
- You will work collaboratively within the copy team and engage with internal and external partners
- Impeccable confident communication skills
- Regulatory writing a plus
- Excellent time management as this is a contract role reporting to the US.