Senior Medical Writer

1 week ago


Surat RS, India Concept Medical Full time

We are looking for Medical Writer in the Clinical Trial Department, Medical writer will be responsible for producing high-quality medical content for class III medical devices, including abstracts, papers, regulatory documents, and product manuals.

They develop literature search protocols, prepare various regulatory documents, and ensure compliance with relevant regulations. Collaborating with physicians, they assist in research-related writing, prepare marketing materials, and develop training content.

Strong skills in clinical concepts, technical writing, critical thinking, and project management are required, along with staying updated on industry practices and regulations.

Job descriptionWrite and edit high-quality medical abstracts, papers, articles, brochures, regulatory documents, and product manuals for class III device.
Develop literature search and review protocols.
Identify industry trends by reviewing related literature searches.
Prepare CEPs, CERs, literature search protocols and reports, CSRs, SSCPs, PMCF protocol, and PMCF report for class III devices. Prepare various regulatory documents related to clinical.
Prepare and update procedures related to Clinical Trial Department accordance with MDR, 21CFR and others.

Responsible for quality and compliance and ensure that activities are performed in accordance with policies, guidelines, current regulatory requirements, and other relevant standards both globally and regionally.

Go through medical topics and assist physicians in writing research related articles and reviewsAssist in preparing press releases and marketing material.

Prepare training materials and eLearning content according to the needs of the audience.
Stay up to date on current industry practices and regulationsSkillsBroad & In-Depth Expertise in Clinical Concepts and RegulationsTechnical WritingAnalytical ThinkingCritical ThinkingLiterature ResearchData InterpretationProject ManagementMedical Communications

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