Cardiology Medical Writer & FDA Compliance Clinician

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

Job summary

ClinChoice is seeking a clinical expert to lead the complaint intake review process in Manila. You will link patient presentation, events, and product interaction with clinical rationale and provide guidance to engineering, quality and innovation teams under Associate Director supervision to ensure FDA-compliant coding and case reviews.

You will collaborate with post-market operations and regulatory review, review intake narratives, support medical safety and medical office guidelines, and

Qualifications

• Minimum of 5 years cardiology experience preferred.
• Demonstrate effective collaboration through previous partnerships and activities.
• Must have a keen sense of prioritization, organization, flexibility, and time management to ensure maximum effectiveness for the benefit of the team.
• Able to maintain confidentiality, establish secure filing procedures and safeguard materials and information required.
• Possess executive communication skills Demonstrates high level of professionalism
• Ability to influence cross functional teams in a constructive manner
• Proficiency in medical writing skills
• Proficiency with Microsoft office programs required

Responsibilities

• Collaborate with the post market complaint operations and regulatory review teams to ensure coding guidelines are adhered to
• Review complaint intakes for coding accuracy and provide written narratives to meet FDA standards
• Collaborate with the Medical Safety Office and Medical Office to provide updated guidelines to the Coding Guide
• Provide clinical support for post market engineering as needed

Skills

Cardiology experience

Cross-functional collaboration

Prioritization

Executive communication

Confidentiality

Time management

Medical writing

Education

BS in Nursing

Registered Nurse

Tools

Microsoft Office

Job description

ClinChoice is seeking a clinical expert to lead the complaint intake review process in Manila. You will link patient presentation, events, and product interaction with clinical rationale and provide guidance to engineering, quality and innovation teams under Associate Director supervision to ensure FDA-compliant coding and case reviews.

You will collaborate with post-market operations and regulatory review, review intake narratives, support medical safety and medical office guidelines, and