Senior Medical Writer (UK - work from home)

Location
UK - work from home
Salary
40,000 - 60,000
Posted
28 Jun 2019
Closes
28 Jul 2019
Ref
373
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Overview:

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.

Responsibilities:

  • 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

We offer:

  • Excellent remuneration and benefits package
  • Top 5 pharmaceutical client projects
  • Superb support, training and development prospects
  • 100% home working

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