
Regulatory Document Specialist
2 days ago
We are seeking a skilled Regulatory Document Writer to join our team. In this role, you will be responsible for writing and reviewing various safety reports for global regulatory submissions.
The ideal candidate will have excellent communication skills, attention to detail, and experience in writing safety reports and regulatory documents. Additionally, proficiency in SQL, Python, and Core Java is preferred.
- Key Responsibilities:
- Write and review safety reports for global regulatory submissions.
- Author and review Risk Management Plans, ad hoc reports, Benefit-Risk Evaluation reports, and medical device reports.
- Draft Common Technical Document Summaries, including Non-Clinical and Clinical Overviews, Clinical Summaries, and other regulatory documents as assigned.
- Conduct trainings for peers and junior team members.
- Prepare medical information responses for Healthcare Professionals (HCPs).
- Perform/review signal detection activities and participate in signal/safety review meetings with clients.
Requirements:
- Bachelor's degree in a relevant field.
- Excellent communication skills and attention to detail.
- Experience in writing safety reports and regulatory documents.
- Proficiency in SQL, Python, and Core Java preferred.
- Ability to mentor junior team members and conduct trainings.
- Strong analytical and problem-solving skills.
- Familiarity with regulatory requirements and guidelines.
- 1-8 years of relevant experience.
Benefits:
- Opportunity to work on high-profile projects.
- Collaborative team environment.
- Ongoing training and development opportunities.
How to Apply:
- Please submit your resume and cover letter.
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