Senior Medical Writing Associate — Regulatory Clinical Reports

ClinChoice; Pasig; On-site; PHP 480,000 - 720,000; Full time

Job summary

ClinChoice seeks a medical writer to support regulatory submissions and safety reporting, including CERs, SSCPs, PSURs, PMA/HDE IDE, and HEMA research. Role adapts to project needs and involves peer-review support to ensure timely, compliant delivery.

The position requires 1–3 years in medical writing, strong English, and excellent time management with minimal supervision. Adherence to QMS/ISMS/PIMS and data confidentiality is essential.

Qualifications

• At least 1-3 years of experience in medical writing, or any related field as applicable.
• Proficient in time management and can work with minimal supervision.
• Proficiency in oral and written English language.

Responsibilities

• Performs tasks according to the assigned medical writing activities including systematic literature reviews primarily for the generation of CERs, SSCPs, SOA, PMS including PSURs and PMA FDA Reports, HDE, IDE Reports, and HEMA research.
• Supports review of work done by peer teammates, on need basis.
• Alerts and escalates to senior members as required when project deliverables risk delay.
• Ensures error-free and acceptable quality of assigned deliverables.
• Responsible for ensuring training compliance and timesheet compliance.
• Ensures that all assigned goals (e.g., utilization and efficiency) are met as per set standards for the performance year.
• Follows and complies with the Company's Code of Conduct, Policies, and Procedures.
• Responsible for confidentiality, integrity, availability, and safeguarding of data.
• Responsible for reporting of security incidents and PIMS breaches as applicable.
• Complies with company QMS, ISMS, and PIMS requirements and applicable regulatory requirements.
• Demonstrates adherence and compliance to PIMS/GDPR requirements.

Skills

Medical writing

Education

Bachelor's degree in life sciences

Tools

MS Office

Job description

ClinChoice seeks a medical writer to support regulatory submissions and safety reporting, including CERs, SSCPs, PSURs, PMA/HDE IDE, and HEMA research. Role adapts to project needs and involves peer-review support to ensure timely, compliant delivery.

The position requires 1–3 years in medical writing, strong English, and excellent time management with minimal supervision. Adherence to QMS/ISMS/PIMS and data confidentiality is essential.