EUMDR Medical Writer

Medical Writer
Kelly Science and Clinical FSP is currently seeking a Medical Writer for a long-term engagement one of our Global Medical Device clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.

JOB GOAL:
The Medical Writer assists in the planning and execution of medical writing activities related to the implementation of EU MDR including systematic literature reviews, Clinical Evaluation Plans (CEPs) and Reports (CERs), Post-Market Clinical Follow-up Evaluation Reports (PMCFERs), and other clinical research documents for assigned therapeutic area and projects.

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.
• Assist/lead 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.
• Completes document format, content and layout according to client EU MDR compliant templates.
• Ensure maintenance clinical documents in a document control management system (e.g. Agile).
• Ensure documents are produced in accordance with procedures, internal and external guidelines (e.g. EU MDR, MEDDEV 2.7/1 Rev 4) and electronic templates.
• Maintain compliance with corporate policies, state, federal and international regulations.
• Liaise with internal and external partners to ensure objectives and deadlines are met. Gives 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)