A well estbalished Medical Devices company based in the Midlands is looking to add a Medical Writer to their team.
Serves as a technical resource in upgrading Policies, Procedures, and Work Instructions for the 109 Facility. Provides technical expertise and creative talent to improve manufacturing and quality system documentation. Assures that all project activities are compliant with US, EU, and regional regulations. Performs related functions as required.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Produce new and revise existing Clinical Evaluation Reports in compliance with major regional regulations and guidance documents (e.g. Europe, Australia, China)
- Produce new and revise existing clinical documents as required by regulations, such as benefit-risk analyses, Postmarket Surveillance and Postmarket Clinical Follow Up reports, Periodic Safety Update Reports.
- Author or review other Medical Affairs documents as required, such as white papers, literature reviews, etc.
- Strong interpersonal skills with the proven ability to build strong and effective working relationships with internal and external stakeholders
- Meet all required project and document deadlines.
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
- Medical writing qualification
- Experience in medical writing for medical device, pharmaceutical, or similar health science company
- Bachelor’s degree in Health Sciences, Science, Engineering or Medical discipline
- 5 years’ experience as a Medical Writer
- Previous experience completing Clinical Evaluation Reports for European or Australian product approval
- Experience in Medical Device product development environment
If interested, apply now or alternatively reach out to me on 014744692 or email@example.com.