Sr. Medical Writer Clinical Evaluation Report (CER)

Company Description

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. 

Job Description

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 requirements.
• Work with the project team leader to ensure the assigned tasks are done on time and within budget.

Qualifications

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

Additional Information

• All candidates must be legally eligible to work in the United States.
• ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***