EUMDR Medical Writer

Responsibilities

• Prepares clinical research documents to support registrations for clients medical device product lines including literature reviews, clinical evaluation plans (CEPs) and reports (CERs), post-market clinical follow-up evaluation reports (PMCFERs), summary of safety and clinical performance (SSCPs) and other clinical documents as needed.
• Communicates with other medical writers, clinical scientists, clinical study managers, engineers, project managers, regulatory associates, risk management, product safety, etc. to correctly incorporate technical content and new EU MDR requirements.
• Aid in literature searches (generating literature search protocols, reviewing/appraising results obtained, summarizing/analyzing pertinent clinical literature) including identification of new risks/hazards (vs. risk assessments) relevant to product(s) under evaluation.
• Utilize software to support the core process steps for systematic literature reviews (e.g. Distiller).
• Understand, interpret and summarize complex results from the scientific literature including statistical results of clinical studies; present results in a clear, concise and scientifically accurate manner for end users (e.g. regulatory bodies, etc.).
• Collect and compile available clinical evidence for CER updates (clinical study outcomes, post-market surveillance data, PMCF activity updates, etc.).
• Incorporate text, tables, graphs, charts, statistical analyses, etc. into clinical documents in a clear and accurate manner.
• Complete document format, content and layout according to client EU MDR compliant templates.
• Maintain clinical documents in a document control management system (e.g. Agile).
• Maintain compliance with corporate policies, state, federal and international regulations.
• Liaise with internal and external partners to ensure objectives and deadlines are met. Give instruction and guidance where needed to ensure the work of others is complete and accurate.

Requirements

• College degree: BA, BS or BSN
• 5 years of related job experience in medical or scientific writing; less than 4 years with advanced degree (M.S. or higher) may be acceptable.
• 3-5 years experience within the medical device industry and CER document creation under MEDDEV 2.7/1 Rev 4 and EU MDR
• Able to quickly develop therapeutic expertise within product areas assigned
• Strong oral communication, project management and prioritization skills
• Excellent interpersonal skills
• Highly proficient in Microsoft Office Suite (MS WORD in particular)

PREFERENCES

• Advanced science degree (MS, PhD, OD, etc.)
• Experience in Ophthalmic or Ophthalmology field
• Experience with EU MDR regulations and requirements for clinical evaluations
• Demonstrated knowledge and experience in clinical research, product development, risk management, quality regulatory compliance, adverse event reporting
• Able to understand and interpret statistical results of clinical studies
• Skilled in narrative or systematic literature reviews (e.g. PRISMA, Cochrane)
• Experience in scientific writing/knowledge understanding of International Committee of Medical Journal Editors (ICMJE) guidelines
• Experience using software systems to manage literature data (e.g. Distiller)
• Proficient in bibliographic software (e.g. Endnote, Reference Manager)