Senior Medical Writer (UK - work from home)
- Experience Level
- Experienced (non-manager)
GCE Solutions have a growing Medical Writing team and we excited to expand our European presence. You will be working in a support global environment, collaborating with blue-chip pharmaceutical clients and providing exceptional Medical Writing support.
- Authors high quality Clinical Evaluation Reports (CERs), Clinical investigation plan, clinical data reports/summaries and post market surveillance summaries, for devices, without any supervision.
- Maintains/updates existing company CERs, regularly based on ongoing clinical evaluations, according to internal standard operating procedures.
- Support periodic assessments of device safety and efficacy in support of post-market surveillance and risk management objectives.
- Lead internal team review and gain cross-functional inputs approval for CERs; ensure that critical information is transmitted to relevant parties in a timely manner
- Communicates/collaborates with outside consultants in the development of CERs when necessary.
- Develop and Manages CER project plans and timelines and ensure that deliverables and milestones are met.
- Proficient in developing device-related manuscripts for biomedical journals, scientific abstracts, conference presentations and posters.
- Conducts proofreading, editing, quality check, review comment integration and document completion/approval activities and ensures compliance as per applicable guidelines.
Therefore if you have the following:
- MSc or PhD in relevant discipline
- Minimum of 5 years writing experience within a medical device or pharmaceutical organisation
- Hands on experience in Scientific and Medical Affairs, Clinical or Regulatory role
- Experience in writing scientific documents for regulatory or journal submissions
- Demonstrated ability to build positive relationships, flexible and must have extensive knowledge of MDD, MDR and MEDDEV requirements
- Analytical thinker and experience of literature searches in Embase and PubMed or OVID
- Experience using Microsoft Word, Excel and PowerPoint
- Effective communicator and team collaboration skills
- Excellent remuneration and benefits package
- Top 5 pharmaceutical client projects
- Superb support, training and development prospects
- 100% home working
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