Regulatory Medical Writer
- Experience Level
- Experienced (non-manager)
A growing biopharmaceutical organisation are currently looking for a Regulatory Medical Writer to join them on a contract basis. This is a fantastic opportunity to be at an organisation focused on discovering, developing and bringing more, pioneering medicines to patients.
Please note that to be considered for this role you must have the right to work in this location.
- You will contribute to the planning of data analyses and presentation for clinical study reports and submission documents; review statistical analysis plans and related documents.
- Act as subject matter expert for regulatory requirements within clinical study and submission teams to ensure compliance of documentation to internal company standards and external regulatory guidelines.
- Write and review clinical regulatory documents such as clinical study reports and NDA/MAA submission documents.
- You will lead medical writer for submission documents and contribute scientifically and strategically at the project and/or study team level to facilitate efficient development of high-quality clinical documents for regulatory filing.
- Partner with the in-house Editorial Group to produce high-quality final documents and ensure timely delivery.
- Educated at a university degree in life sciences or other relevant scientific discipline required.
- At least 5 years as a medical writer in the pharmaceutical industry across several therapeutic areas.
- Well-developed and proven medical writing skills, combined with an ability to interpret and present complex scientific data from different disciplines in a clear, concise format.
- Excellent knowledge of global regulatory environment, including key document requirements, reporting guidelines and approval processes.
- Excellent social and presentation skills.
- The capability to work independently and as part of a team.
- Strong ability to work under pressure, prioritize multiple deadlines and projects and meet challenging deadlines.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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