We are currently partnered with a global biotechnology company, who are seeking an experienced regulatory writer to contribute to the development of complex clinical, nonclinical, and safety 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 in Immunology.
Contractual details:
- 12 Months
- Outside IR35 (If applicable)
- 35-40 hours per week
If this opportunity sounds to be a great fit for you based on your skills and experience, then please do reach out!
*Please note that the desired freelancer can be based anywhere in Europe for this role*
