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Job Description
Key responsibilities include:
- Perform data collection for report planning and strategy development.
- Write safety reports for global regulatory submissions, including Annual Reports, Periodic Safety Update Reports, and more.
- Conduct quality review of safety reports prepared by junior or associate medical writers.
- Author or contribute to ad hoc reports and benefit-risk evaluation reports.
- Prepare medical information responses for healthcare professionals.
- Contribute to signal reports and safety issue analysis reports.
- Author subject narratives for adverse drug reactions and serious adverse events.
- Participate in label creation and updates, including Core Data Sheets and Med Guides.
- Conduct literature searches and review articles for various reports and surveillance activities.
- Implement consistent and efficient processes to meet timelines and quality standards.
- Ensure compliance with regulatory requirements and promote a culture of high customer service.
- Perform additional activities as per project requirements and managers discretion.
Qualifications:
- Bachelors and/or Masters degree in Healthcare or related field.
- Strong communication and writing skills.
- Familiarity with clinical research and regulatory requirements.
- Ability to work collaboratively in a dynamic environment.
- Detail-oriented with strong organizational skills.