Medical Writer

4 weeks ago

delhi, India Life Sciences Recruitment Full time
Job Overview:
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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