Senior Medical Writer required for established pharmaceutical company based in Berkshire, UK.
Our client, an established Pharmaceutical company, are currently looking for a Senior Medical Writer are currently looking for a Senior Medical Writer to join their team based in Berkshire, UK.
As Senior Medical Writer, you will ensure that medical writing documents are prepared according to appropriately rigorous, objective and informative medical writing procedures and processes. You will be working to strict time guidelines, so it is important that your work is accurate and that the data presented will withstand examination by regulatory bodies. You can be home based depending on the level of your experience.
Further key responsibilities of this Senior Medical Writer role will include to:
- Take responsibility for supervision / production, review, publishing, and finalisation of medical writing documents (in particular, clinical summary documents, literature review, Investigator’s Brochures, protocols and clinical study reports) for regulatory submission.
- Plan, schedule and track all assigned medical writing document activities, in close cooperation with the senior team members for the appropriate disease area.
- Ensure high quality, timely and accurate completion of all documents at each point in the document lifecycle, and to provide monthly status reports to the senior team members.
- Where appropriate to seek the input of the team members as clinical author or reviewer.
- Provide appropriate guidance to internal and external writers for all medical writing activities.
- Take responsibility for ensuring that the assigned medical writing deliverables meet the project specifications, and that they are produced to defined quality, content and timetables standards.
- Where delegated by the your line manager, to supervise medical writing activities contracted to third party suppliers and to ensure that outsourced medical writing deliverables meet the project specifications, and that they are produced to defined quality, content and timetables standards.
- Where delegated, to take responsibility as a medical writing adviser to project teams at any level.
- Work with the Document Management Assistants to ensure quality, timely and accurate deliverables at each stage of the document lifecycle, to contribute to and to supervise accurate and timely publishing within EDMS.
- When required, to develop medical writing processes within the company by working with the senior team members.
- Interact with other groups in order to provide an efficient, effective and timely medical writing service. Groups will include Clinical Development Teams, Study Teams and other groups as appropriate.
- Perform any other activity as may reasonably be required from time to time. <p>
- Complete all activities within the framework and in compliance with ICH Guidelines, R&D SOPs.
The ideal candidate for this Senior Medical Writer job will have a minimum Life Science degree, preferably with a higher degree (MSc or PhD) or other relevant qualifications. A sound understanding of GCP, coupled with prior experience in clinical/preclinical pharmaceutical research and development is essential. In addition, a good understanding of the clinical development process and of ICH guidelines along with significant experience of working on summary level documents such as the Common Technical Document or Investigator’s Brochures is also essential.
How to Apply
To register your interest in this Senior Medical Writer job, please contact Hendre Moolman on +44 (0)1438 870 023 or email email@example.com quoting 19411.
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