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MDR - Medical Writer (Remote)

Danvers, MA 01923

Posted: 03/24/2023 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 549262 Is job remote?: Yes Country: United States

Job Description

Top 3 skills needed:
1. Having publications in biomedical journals
2. Strong communication skill
3. Data analysis skill  

The Medical Writer is responsible for the preparation of documents that support the presentation, publication, regulatory clinical document submission needs of assigned therapeutic areas including class III and implantable medical devices in the Medical Surgical group.


A Day in the Life
  • This role predominantly focuses on writing, editing and reviewing regulatory (e.g., Clinical Evaluation Reports/clinical study reports/summaries/Summary of Safety and Clinical Performance / Periodic Safety Update Report etc.) documents and responses to Notified Bodies.
  • Post Market Surveillance activities (monthly literature review of our product
  • Conduct proofreading, editing, document formatting, review comment integration and document completion / approval activities
  • Collaborate with cross-functional team to assure high quality and successful project delivery
  • Seek out and engage regularly with peers, creating an environment of exchange and learning. Openly share successes and failures to promote the group’s collective learning. Administration of the applicable databases for the activities related to the evaluation of clinical data, Clinical Evaluation reports and Post Market surveillance reporting.
  • Collaborate with principal investigators, statistical and clinical communications teams on formulating first drafts of manuscripts.
  • Create and manage project schedules for each clinical evidence document.


Must Have: Minimum Requirements 
  • Bachelors Degree
  • Minimum of 4 years medical or clinical writing experience

            Or Advanced Degree with minimum of 2 years medical or clinical writing experience

Nice to Have
  • Masters or PhD degree(s) in biomedical sciences or technical disciplines
  • Experience with medical and/or scientific writing within a medical device industry or related industry including preparation of Clinical evaluation reports and post market surveillance reporting.
  • Clinical research experience 
  • Knowledge of EU MDD and MDR requirements
Candidates in CO and NY may not be considered
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