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!
