Medical Reports Specialist

1 day ago

Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 18,00,000 - ₹ 21,00,000
Medical Writer Role

We seek an ambitious and energetic medical writer for the authoring of aggregate safety reports to join our safety team.

The successful candidate will be responsible for authoring/performing QC/review of safety documents. Responsibilities include maintaining quality and timeliness, and compliance to internal/client SOPs and regulations. Key tasks include end-to-end authoring of complex deliverables - periodic aggregate reports, including PBRERs, DSURs, SUSARs, PADERs/PAERs, ACOs, RMPs, and ad-hoc regulatory and safety reports. Additionally, they must perform review to validate accuracy and relevance of data presented in all documents against source data or references used.

Required skills and qualifications:

  • Minimum 2 years experience in medical writing or equivalent experience in life sciences domain with experience in End-to-End authoring of periodic aggregate reports.
  • Knowledge of regulatory documentation, drug development process and global regulations and guidelines.
  • Good knowledge of document management systems and other relevant applications (e.g., Excel, Outlook).
  • Excellent written and verbal communication skills.
  • Excellent organizational and time management skills.

Benefits:
The role offers a unique career opportunity at the intersection of healthcare and technology. You will have the chance to work extensively with clinical and regulatory experts, as well as external contacts to ensure high-quality content, organization, clarity, accuracy, format, and adherence to regulatory and internal guidelines. The combination of this will lead to a truly differentiated experience for you.

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