Sample interview questions: Can you describe your experience with writing regulatory responses or query responses for clinical trial submissions?
Sample answer:
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Experience in responding to regulatory queries and responses:
- Drafted and submitted comprehensive responses to regulatory authorities, addressing queries and concerns related to clinical trial protocols, investigator’s brochures, and clinical study reports.
- Collaborated with clinical research teams, regulatory experts, and legal counsel to ensure accurate and timely responses.
- Demonstrated strong analytical and problem-solving skills in identifying and addressing regulatory issues.
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Expertise in regulatory writing:
- Proficient in following various regulatory guidelines and standards, including ICH GCP, FDA regulations, and EMA guidelines.
- Experience in writing regulatory documents, including clinical trial protocols, clinical study reports, and investigator’s brochures.
- Ability to translate complex scientific and medical information into clear and concise regulatory language.
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Attention to detail and accuracy:
- Demonstrated attention to detail and accuracy in reviewing and responding to regulatory queries and concerns.
- Ability … Read full answer
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