Associate, Medical Writing (PSUR)

Added
5 days ago
Type
Full time
Salary
Salary not provided

Related skills

data management regulatory affairs clinical operations pharmacovigilance medical writing

๐Ÿ“‹ Description

  • Coordinate and compile data to complete a PSUR.
  • Maintain open communication with stakeholders during PSUR writing.
  • Flag data collection delays and coordinate reviews to meet schedules.
  • Ensure compliance with regulations, policies, and procedures.

๐ŸŽฏ Requirements

  • PSUR writing and data coordination experience.
  • Stakeholder communication across Quality/Medical Ops/Regulatory.
  • Knowledge of federal/state/local regulatory requirements.
  • Attention to timelines and on-time PSUR delivery.
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