Description
*Regulatory CSR Medical Writer - 9-Month Contract*I am currently working with a global CRO who are looking to bring in a senior medical writer on a 9 month contract until the end of the year.
Please see the core responsibilities below:
- Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input.
- Ensure document structure, content, and style adheres to FDA/EMA or other appropriate regulatory guidelines, and comply with departmental, corporate or client SOPs and style guidelines, as applicable.
- Scientific background essential; writing experience includes multiple clinical documents: study reports, study protocols, or CTD documents or similar.
- Gather, review, analyse, and evaluate pertinent resources to prepare, develop,and finalise clinical documents for submission to regulatory authorities.
- Briefing documents, investigator brochures, study protocols, model informed consents, interim and final clinical study reports (CSR), common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, and integrated summaries of safety and efficacy are needed
Contractual
- 9 months
- Full FTE
- Salary Negotiable
- Remote
If this role sounds of interest, please do not hesitate to click on the appropriate links to apply.