EU MDR Medical Writer

Kelly Science, Engineering, Technology & Telecom; United States; On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical, Dental, Vision benefits

401K

Paid time off options

Job summary

Kelly Science, Engineering, Technology & Telecom is seeking a Medical Writer for a long-term role with a Global Medical Device client. You will assist in planning and executing medical writing activities related to EU MDR compliance, including clinical documents like Clinical Evaluation Reports (CERs).

The ideal candidate will have a degree, 5 years of experience in medical writing, and proficiency in Microsoft Office Suite. This full-time position includes comprehensive benefits and paid time off options.

Qualifications

• 5 years of related job experience in medical or scientific writing.
• 3-5 years experience in the medical device industry and CER document creation.
• Strong oral communication, project management, and prioritization skills.

Responsibilities

• Prepare clinical research documents for medical device registrations.
• Communicate with clinical scientists and project managers to ensure document accuracy.
• Conduct literature searches and summarize pertinent clinical literature.

Skills

Medical writing

Regulatory compliance

Clinical research

Statistical analysis

Project management

Education

BA, BS or BSN

Advanced science degree (MS, PhD, OD)

Tools

Microsoft Office Suite

Distiller

Bibliographic software (e.g., Endnote)

Job description

Overview

Kelly Science and Clinical FSP is currently seeking a Medical Writer for a long-term engagement with a Global Medical Device client. This role is full-time and part of Kelly FSP (Functional Service Provider), a managed solution provider and business unit of Kelly Services, Inc. The position offers full benefit options and eligibility for Medical, Dental, Vision, 401K and a variety of other benefits. Paid time off options may include 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 the 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 relevant to products under evaluation.
• Utilize software to support 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).
• 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, and statistical analyses into clinical documents in a clear and accurate manner.
• Complete document format, content and layout according to client EU MDR compliant templates.
• Ensure maintenance of 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. Provide instruction and guidance where needed to ensure the work of others is complete and accurate.

Required qualifications

• College degree: BA, BS or BSN; 5 years of related job experience in medical or scientific writing. Less than 4 years with an 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).

Preferred qualifications

• 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, and 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 and knowledge of ICMJE guidelines.
• Experience using software systems to manage literature data (e.g., Distiller).
• Proficient in bibliographic software (e.g., Endnote, Reference Manager).