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A fantastic vacancy has become available for a Medical Writer to join a leading consultancy who deliver clinical excellence from design to delivery. This role will be located in London and will be on a permanent basis.
Please note that to be considered for this role you must have the right to work in this location.
- You will ensure effective scientific document writing and quality control processes are implemented and maintained in order to meet all regulatory requirements to gain timely approval for studies.
- Ensure all departmental documentation created internally as well as outsourced documents are filed appropriately and ready for inspection and audit and address relevant inspection, audit and CAPA items.
- Drive collaboration and innovation within the Advanced Research Science team as well as cross-functionally by implementing continuous process improvements.
- Accountable to provide essential quality control processes to the Advanced Research Science team and optimisation of clinical documents concurrently across a number of studies.
- Assist senior team members in managing and developing entry level positions into the advanced research science department to gain experience and competency in the departmental tasks.
- Excellent communication skills - able to adapt to target audience including patients / volunteers, physicians, regulators, peers etc.
- Able to actively participate to drive process improvement and deliver innovation and enthusiasm.
- BSc in Clinical Pharmacology or other life Science - a higher degree would be particularly attractive
- Track record of creating clinical trial documents (at least 3 years).
- You will have 3 years or more experience in a medical writing/ medical communications role
- Production of clinical study documents to include (among others):
-Clinical Study Protocols (design of complex and adaptive studies incorporating safety considerations for first-time-in-man studies)
-Regulatory and Ethics submission documents
-Clinical Study Report Writing (including analysis and interpretation of data such as PK/PD and safety analyses as well as involvement in data modelling.
- Comprehensive understanding of all regulatory compliance standards.
- Up to date knowledge of current industry practice and trends to ensure that the company's processes and standards remain current and robust.
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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