Medical Writer

Key Responsibilities:

• Write and edit medical documents: The primary responsibility of a Medical Writer is to write and edit scientific and medical documents, including clinical study reports, regulatory submissions, manuscripts, abstracts, and posters.
• Ensure document quality and accuracy: The Medical Writer is responsible for ensuring the quality and accuracy of all medical documents produced. This includes ensuring that all documents are compliant with relevant regulatory requirements and guidelines.
• Review and analyze scientific literature: The Medical Writer reviews and analyzes scientific literature, including medical journals and conference proceedings, to keep up-to-date with the latest developments in their field.
• Collaborate with cross-functional teams: The Medical Writer collaborates with cross-functional teams, including clinical research associates, statisticians, and regulatory affairs personnel, to ensure that medical documents are completed on time and to the required quality standards.
• Manage project timelines: The Medical Writer is responsible for managing project timelines and ensuring that all documents are completed within the required timeframes.
• Develop scientific and medical content: The Medical Writer develops scientific and medical content for a variety of audiences, including healthcare professionals, patients, and the general public.
• Create visual aids and graphics: The Medical Writer creates visual aids and graphics to help convey complex scientific and medical concepts.
• Participate in document review meetings: The Medical Writer participates in document review meetings and presents medical documents to review committees.
• Maintain up-to-date knowledge of industry guidelines and regulations: The Medical Writer stays up-to-date with industry guidelines and regulations, including those related to clinical trials, medical devices, and pharmaceuticals.
• Ensure document standardization: The Medical Writer ensures that all documents are standardized according to company guidelines and that formatting and language are consistent across all documents.

Qualifications:

• Bachelor's Degree with a minimum of 4 years medical or clinical writing experience OR Advanced Degree with minimum of 2 years medical or clinical writing experience required
• Master's or PhD degree(s) preferred 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