RBW Consulting
Freelance Medical Writer – Clinical & Regulatory Writing
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We are looking for experienced Freelance Medical Writers
We are looking for experienced Freelance Medical Writers to support an immediate requirement with a leading international organisation working within the life sciences industry.
This opportunity would suit an experienced clinical/regulatory writer
This opportunity would suit an experienced clinical/regulatory writer who has current availability to take on ad hoc freelance projects and can provide support at relatively short notice.
There is an immediate need for additional medical writing resource. However, this is not a fixed-hours contract and ongoing hours cannot be guaranteed, so we are particularly interested in hearing from established freelancers who are comfortable working on a flexible, project-led basis.
The work
Depending on project requirements, you may be involved in the planning, writing, editing and development of a range of clinical and regulatory documents, including:
- Clinical study protocols
- Investigator brochures
- Clinical study reports (CSRs)
- CSR patient narratives
- Development Safety Update Reports (DSURs)
- IND documentation
- eCTD/NDA clinical summaries
- Briefing books
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You may support documents throughout the development lifecycle, from initial template and first draft through review, QC and final approved version. This could include reference retrieval and bibliography generation, editing in accordance with sponsor or house style, document review processes, formatting, publishing and archiving.
You may also be responsible for interpreting clinical study data and developing clear key messages, providing technical formatting support and carrying out QC of clinical and regulatory documents.
What we’re looking for
You will need:
- Strong professional medical writing experience within clinical and/or regulatory writing
- Demonstrable experience developing clinical and regulatory documents
- A good understanding of relevant regulatory requirements and guidelines, including FDA and ICH requirements
- The ability to work independently and deliver high-quality documentation to agreed deadlines
- Strong attention to detail and experience working within established SOPs and document-development processes
- Immediate or near-immediate availability for freelance projects
- To be based in the UK or EU
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The opportunity
There is an immediate requirement for freelance writing support, and suitable candidates will be reviewed as soon as possible.
The work will be provided on an ad hoc, project-led basis, rather than as a guaranteed-hours contract. This could therefore work particularly well for established freelancers with capacity to take on additional clinical or regulatory writing projects as required.
If you have relevant clinical or regulatory medical writing experience and availability to support projects now, please get in touch to discuss your experience and current capacity.
Please note: Applicants must be experienced Medical Writers with demonstrable clinical and/or regulatory writing experience. This opportunity is not suitable for candidates looking to move into medical writing or gain their first experience within the field.
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