Hendre Moolman at CK Clinical is recruiting for a Medical Writing Manager to join an established pharmaceutical company based in Berkshire.
This Medical Writing Manager role offers a unique opportunity to have involvement with a broad range of medical writing documents study reports, investigator brochures, module II documents, and documents that take an overview of study documents (not just the compound/CMC). This position will support global and regional submissions. This is a customer facing role as part of an internal service provision.
The key responsibilities for this Medical Writing Manager role are the following:
- Ensure that all medical writing documents prepared for assigned Clinical Research Programmes within the company’s R&D are prepared according to appropriately rigorous, objective and informative medical writing procedures and processes.
- Lead the Medical Writing activities for US, European or other regulatory submissions as assigned.
- Ensure documents for assigned clinical trials are prepared, reviewed, and approved in a quality, timely and accurate manner such that the date presented will withstand examination by regulatory bodies.
- Support the full use of the Electronic Document Management System (EDMS), for all clinical documents intended for submission, within the company.
- Plan, schedule and track all assigned medical writing activities in close cooperation with the GPLs to ensure high quality, timely, and accurate completion of all documents at each point in the document lifecycle, and to provide monthly status reports and forecasts to the HMW.
- Take responsibility for supervision/production, review, publishing, and finalization of assigned study reports.
- Work with the HMW and MWM (IBs) for strategic planning, production & review of assigned summary documents.
- Provide disease area guidance to internal and external writers for assigned projects
- Take responsibility for ensuring that assigned medical writing deliverables meet the project specifications, and that they are produced within the timelines to defined quality, and content standards.
- Supervise assigned medical writing projects contracted to third party suppliers, including interim and final integrated study reports and, where appropriate, integrated clinical summaries, protocols or other documents.
- Take responsibility for ensuring that outsourcing of assigned medical writing projects is conducted after a thorough evaluation of the capabilities of the CRO/freelancer concerned, that the deliverables meet the project specifications, and that they are produced within the timelines to defined quality, and content standards.
- Undertake assigned medical writing projects within including interim and final integrated study reports and where appropriate, integrated clinical summaries, protocols or other documents.
- Ensure that assigned protocols, clinical study reports and investigator brochures and other documents as appropriate, are developed with medical writing input as early as possible.
- Take responsibility as a medical writing adviser to project teams across assigned disease areas.
- Work with the publishers 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.
- Develop awareness of the benefits of the EDMS in the preparation of clinical documents.
- 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.
- Keep abreast of current issues and developments in medical writing, particularly those impaction the neurology disease area.
- Perform any other activity as may reasonably be required from time to time.
- Complete all of the above activities within the framework and in compliance with ICH Guidelines, R&D SOPs and other documentation in force within the company.
Successful candidate for this Medical Writing Manager role will enjoy the benefits of working with a global Pharmaceutical company, including a competitive salary.
The ideal candidate for this Medical Writing Manager role will have the following qualificaitions and
- Life Science Degree, preferably with a higher degree (MSc or PhD) or other relevant qualifications
- Good understanding of GCP, coupled with prior experience in clinical/preclinical pharmaceutical research and development.
- Good understanding of the clinical development process and of ICH guidelines
- Significant experience of working on summary level documents such as the Common Technical Document or Investigator’s Brochures.
How to apply:
For more information or to apply for this Medical Writing Manager job please contract Hendre Moolman on 01438 743 047 or email email@example.com. Please quote reference CL24065 in all correspondence.