Associate Medical Writer
Associate Medical Writer Interview Questions and Answers
Q1. What are Medical devices- why do we need regulatory guideline and documents for them?
Medical devices are instruments, machines, implants, or other similar articles used for diagnosis, treatment, or prevention of diseases.
Medical devices are regulated to ensure their safety and effectiveness.
Regulatory guidelines and documents provide a framework for manufacturers to follow during the development, testing, and marketing of medical devices.
Examples of medical devices include pacemakers, artificial joints, diagnostic imaging equipment, and surgical instruments.
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Q2. What are the steps involved in drug development?
Drug development involves several stages from discovery to approval.
Discovery and research
Preclinical testing
Clinical trials
FDA review and approval
Post-marketing surveillance
Manufacturing and distribution
Associate Medical Writer Interview Questions and Answers for Freshers
Q3. Source for section 16 PSUR
Section 16 PSUR can be sourced from the regulatory authorities or the company's internal database.
Regulatory authorities like FDA or EMA provide guidelines for PSURs
Internal database of the company may contain previous PSURs for reference
Q4. Introduction of onself
I am a highly motivated and detail-oriented individual with a passion for medical writing.
I have a degree in biology and experience in scientific research
I have excellent writing and communication skills
I am familiar with medical terminology and literature
I am a quick learner and able to work independently or as part of a team
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