Associate, Medical Writing (PSUR)

ClinChoice ANZ; Pasig; On-site; PHP 600,000 - 900,000; Full time

Job summary

ClinChoice is seeking a PSUR Coordinator to manage data coordination and compilation for periodic safety update reports. You will ensure timely communication with stakeholders across Quality, Medical Operations, Clinical, Regulatory Affairs, and Medical Safety to align on schedules and deliver accurate PSURs.

The role requires meticulous data handling, adherence to regulatory requirements, and proactive problem solving to keep submissions on track and compliant globally.

Responsibilities

• Coordinate and compile data to complete a PSUR.
• Maintain open communication with stakeholders (Quality, Medical Operations, Clinical, Regulatory Affairs, Medical Safety, etc.) through the PSUR writing process.
• Flag concerns/delays with data collection/reviews to ensure on-time completion of PSUR reports.
• Ensure personal and Company compliance with applicable regulations, policies, and procedures.

Job description

About Clinchoice

ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis.

About Clinchoice

ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis.

Our global delivery network has expanded to centers and satellite offices in the United States, Mexico, United Kingdom, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally.

We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision.

Job Description

Primary Responsibilities

• Responsible for the coordination and compilation of the relevant data to complete a PSUR.
• Ensures open communication with the stakeholders (Quality, Medical Operations, Clinical, Regulatory Affairs, Medical Safety, etc.) through the PSUR writing process to ensure adherence to published schedules.
• Communicate concerns/delays with data collection and/or reviews within the PSUR Manager Medical Operations to ensure on time completion of the PSUR reports.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.