What are the responsibilities and job description for the Medical Writer position at VirtualVocations?
A company is looking for a Medical Writer responsible for creating clinical documentation and collaborating with various stakeholders in the Clinical Affairs Department.Key ResponsibilitiesPrepare Clinical Evaluation Reports (CERs), Post Market Clinical Follow-Ups (PMCFs), and Investigator Brochures (IBs)Collect and analyze clinical data to support regulatory submissions and studiesDevelop procedures and workflows related to medical writing and collaborate with internal and external partnersRequired QualificationsBachelor's in Life Science required; advanced degrees (MS, MA, MPH, PharmD, PhD, MD) preferred3 years of experience in Medical Writing; 5 years preferredSolid understanding of EU regulations, Good Clinical Practice, and ICH guidelinesExperience writing MEDDEV 2.7.1 rev 4 and MDR compliant documents is requiredKnowledge of Good Clinical Practice (GCP), FDA regulations, and ISO 14155 is a plus