Medical Writer
4 weeks ago
The Medical Writer (CER) will be responsible for developing and maintaining Clinical Evaluation Reports in accordance with EU Medical Device Regulation (MDR), MEDDEV 2.7/1 Rev 4, and other relevant regulatory standards. The successful candidate will have a strong background in clinical research, regulatory writing, and technical communication, with a deep understanding of clinical data analysis and interpretation. This role requires close collaboration with cross-functional teams, including clinical research, regulatory affairs, and product development, to produce high-quality documentation that supports product safety, performance, and compliance.
Key Responsibilities:
- CER Development: Author, edit, and update Clinical Evaluation Reports (CERs) to support new product registrations, renewals, and post-market surveillance requirements in compliance with MDR and MEDDEV 2.7/1 Rev 4.- Literature Reviews: Conduct systematic and targeted literature reviews to identify, summarize, and interpret clinical data relevant to product safety and performance.- Clinical Data Analysis: Analyze and interpret clinical study data, safety information, and adverse event reports to support CER findings and conclusions.- Cross-Functional Collaboration: Work closely with clinical, regulatory, quality, and product development teams to gather relevant data, insights, and feedback for CER documentation.- Compliance & Quality Assurance: Ensure that all documentation is accurate, evidence-based, and aligned with regulatory requirements, company standards, and current best practices.- Data Interpretation & Synthesis: Synthesize clinical data and scientific evidence from various sources to support product safety, efficacy, and performance conclusions.- Continuous Improvement: Keep up-to-date with changes in regulatory guidelines and industry best practices, and proactively recommend updates to documentation processes to enhance efficiency and compliance.
Qualifications:
- Education: Bachelor’s degree in life sciences, medical sciences, or a related field; advanced degree (MS, MPH, PhD) preferred.- Experience: Minimum of 2–3 years’ experience as a medical writer in the medical device industry, with a strong focus on CERs and regulatory documentation.- Skills:- Demonstrated expertise in writing Clinical Evaluation Reports in compliance with MDR, MEDDEV 2.7/1 Rev 4, and relevant regulatory frameworks.- Strong analytical skills, with the ability to interpret complex clinical data and synthesize findings into clear, compelling documentation.- Excellent written and verbal communication skills, with meticulous attention to detail.- Knowledge of medical terminology, clinical research principles, and systematic literature review techniques.- Proficiency in MS Office Suite and reference management tools (e.g., EndNote, Mendeley).- Attention to Detail: Highly detail-oriented, with a commitment to producing high-quality, error-free documentation.
Preferred Qualifications:
- Experience with post-market surveillance and risk-benefit analysis documentation.- Familiarity with additional regulatory documents (e.g., PMCF reports, risk management documentation).- Knowledge of biostatistics and data visualization tools is an asset.
What We Offer:
- Professional Development: Access to continuous learning, career advancement, and growth opportunities within a supportive environment.- Flexible Work Arrangements: Hybrid or remote options, depending on location.
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