Great client is looking for a long-term contractor. The role can be remote, although the preference is to have this position onsite. The purpose of this role is to use medical writing and literature review experience to generate Clinical Evaluation Reports (CERs) and other associated documents in accordance with the appropriate regulatory standards (EU MDR) to ensure continued CE registration of company products.
location: Cordova, Tennessee
job type: Contract
salary: $45 - 52 per hour
work hours: 8am to 4pm
Leads completion of clinical evaluation reports (CERs), Benefit Risk Analysis (BRAs), Clinical Evaluation Plans (CEPs), and Summary of Safety and Clinical Performance (SSCPs) for CE registration including guidance to less experienced team members 75%
Works with internal teams to gain cross-functional inputs and approvals into evidence evaluation documentation activities 15%
Generates and maintain reference databases 10%
- Bachelors in a relevant discipline required. Master's degree or PhD preferred.
- Minimum 2 years' experience authoring Clinical Evaluation Reports
- Proven experience of performing literature reviews, analysing data sets and communicating the outputs.
- Experience working within a medical device company in a Research & Development, Scientific and Medical Affairs, Clinical or Regulatory role.
- Experience in writing scientific documents for regulatory submissions
- Experience in presenting scientific/clinical evidence in a written and oral manner to cross-discipline teams.
- Excellent scientific writing skills.
- strong data extraction and analysis skills.
- Good communicator and able to work collaboratively as part of a team.
- Self-motivated and able to work independently.
- Excellent time management skills and ability to work under pressure to deadlines.
- Must exhibit high quality, ethical and compliant work habits.
- Experience in using Microsoft Word, Excel, PowerPoint.
- Experience with EndNote.
- Experience level: Experienced
- Minimum 3 years of experience
- Education: Bachelors (required)
- Clinical Evaluation Reports (2 years of experience is required)
- Medical Device (3 years of experience is required)
- EndNote (1 year of experience is preferred)
- MIcrosoft Office (3 years of experience is preferred)
- scientific documentation (1 year of experience is preferred)
- Technical Writing (3 years of experience is preferred)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.