Remote Medical Writer (Clinical Evaluation Reports (CER) or Post-Marke

Posted on Jan 31, 2021 by IDC Technologies Solutions Ltd

 

• Medical writer experience for minimum 2-5 years ( Recent)
• At least 2 years' recent experience in writing Clinical Evaluation Reports (CER) or Post-Market Surveillance Reports (PMSR). (Not looking for people who are doing complaint working, like managing the data or kind of triaging work)
• Good knowledge in drafting literature review and state of the art documents (This is part of CER)
• Pharmaceutical background - Aggregate reporting (either experience in Periodic Safety Update Reports (PSUR) or Periodic Benefit Risk Evaluation Reports (PBRER). - We may try them but do not focus much on these kind of candidates.
• Good knowledge of MEDDEV Rev 4 guidance.
• Understanding of MDR (Medical Device Regulations) regulations.