Sr. Medical Writer Clinical Evaluation Report (CER, REMOTE)
Company: ProPharma Group
Location: Salt Lake City
Posted on: November 25, 2022
ProPharma Group is an industry leading, single source provider for
regulatory compliance, pharmacovigilance, and medical information
services across the full development lifecycle for pharmaceutical,
biotechnology, and medical device companies. Operating around the
world with offices in Australia, Canada, Germany, Japan, the
Netherlands, Sweden, United Kingdom, and the United States,
ProPharma Group's fully integrated service offerings will provide
clients with a comprehensive suite of global support services that
are required to be competitive in today's dynamic markets. We build
successful long-term relationships with clients by providing
leading industry knowledge, experience, and proven processes.
Our subsidary, M Squared Associates, is a consulting firm providing
regulatory, quality systems and clinical research (CRO) services to
US and international medical technology firms.
We have an immediate need for a Clinical Evaluation Report (CER)
specialist with demonstrated expertise in medical devices,
literature search methodologies, and the EU Medical Device
Regulation (EU MDR).
The CER Specialist will work on a per project basis as a part of a
multi-specialty project team responsible for a variety of client
projects. This person will be responsible for CER writing
activities in coordination with project teams, under the direction
of our Senior Project Manager.
Essential Functions Include
- Review technical documentation and clinical data for
incorporation into Clinical Evaluation Reports.
- Perform literature searches in Embase and PubMed and screen
literature citations for relevancy.
- Summarize relevant literature and integrate with new or
existing information to satisfactorily meet the EU MDR requirements
for Clinical Evaluation Reports.
- Maintain responsibility for assigned projects: meeting
deadlines, communicating project status to internal teams and
project manager, and completing work according to project
- Work with the project team leader to ensure the assigned tasks
are done on time and within budget.
Qualified Candidates Must Have
- Bachelor's degree or higher and at least 5 years of documented
professional experience in the medical device industry
- Medical writing experience in authoring Clinical Evaluation
Reports and knowledge of the EU MDR
- Possess knowledge of literature search methodology and
experience with relevant databases such as Embase and PubMed
- Working proficiency in Microsoft Word, Excel
- Effective verbal and writing skills
- All candidates must be legally eligible to work in the United
- ***ProPharma Group does not accept unsolicited resumes from
recruiters/third parties. Please, no phone calls or emails to
anyone regarding this posting.***
Keywords: ProPharma Group, Salt Lake City , Sr. Medical Writer Clinical Evaluation Report (CER, REMOTE), Healthcare , Salt Lake City, Utah
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