Description
We are currently partnered with a global CRO, who are seeking a Senior Regulatory Writer to handle their complex regulatory documents for regulatory submissions.Key responsibilities:
- Prepare, develop and finalise clinical documents for submission to regulatory authorities including briefing documents, IBs, study protocols, CSRs and CTDs.
- Ensure these documents adhere to FDA/EMA or other regulatory guidelines and comply with clients SOPs.
- Looks beyond existing methodologies and own discipline to define and resolve complex problems in areas critical to the achievement of objectives.
Requirements for the role:
- Minimum experience of 6 years in preparing and writing clinical documents for submission to regulatory authorities.
- Extensive writing experience in multiple clinical documents such as CSRs, CTDs, study protocols etc.
- Good understanding of project planning, including identifying critical paths, time line requests, project resolutions etc.
- Experience working across various therapeutic areas.
If this role sounds like a great opportunity based on your skills and experience, then please do reach out!
I look forward to hearing from you!