Associate Medical Writer

Associate Medical Writer Interview Questions and Answers

Updated 20 May 2024
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Q1. What are Medical devices- why do we need regulatory guideline and documents for them?

Ans.

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.

  • R...read more

Q2. What are the steps involved in drug development?

Ans.

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

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Q3. Source for section 16 PSUR

Ans.

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

Ans.

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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