Lead Medical Writer
Hobson Prior are currently working with a Swiss global healthcare organisation who are focused on offering medical solutions in order to transform patients' lives. Our client is looking for a Lead Medical Writer to work closely with a team of clinical scientists and functional experts working in early phase drug development and be accountable for delivery of quality clinical documents including but not limited to protocols and informed consent.
- You will actively support the writing needs for a variety of clinical team stakeholders: edits, re-writes and/or proofreads a wide range of clinical documents to ensure accuracy and compliance with local and global guidelines.
- Co-operates with the Regulatory Documentation Group to ensure that effective medical writing processes and standards are implemented to achieve deliverables.
- Manages and supports the outsourcing of documents to external medical writers.
- Plans timelines for writing review and editing of documents to ensure alignment with project timelines.
- Partakes as needed as a member or ad-hoc participant of key functional/cross-functional teams to ensure appropriate documentation guidance and support.
- Supports selection and management of appropriate templates within document management system.
- Ownership of protocol with process/good project management skills needed.
- Ability to work well with global teams to complete deliverables along with coordination of cross-function review process and all tasks associated with protocol writing.
- A Bachelors' degree in a scientific discipline (Advanced degree preferred).
- Experience in Pharma industry and experience in medical writing are required.
- Thorough understanding of multidisciplinary functions involved in Drug Development Process is essential (e.g., Clin Ops, Biostats, Regulatory, etc.) is required.
- Experience providing writing support for various therapeutic areas and global programs is desirable.
- Experience in supporting preparation of clinical study protocols is preferred.
- Understanding of Federal Regulations and International standards as they pertain to reporting of clinical trials.
- Fluent in English.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back 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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