Job Title: Senior Manager / Medical Writing
Location: Manila, Philippines
Category: Consulting
Job Type: Full Time
Posted Date: May 22nd, 2025
Job ID: R257332
Estimated Salary: PHP 1,800,000 – PHP 2,500,000 per annum
About Cencora
At Cencora, our team members are at the heart of everything we do. United by our responsibility to create healthier futures, every person here is essential to delivering on that purpose. Join our innovative company to make a difference at the center of health and help improve the lives of people and animals everywhere.
Job Details
Role Summary:
This role involves preparing technical documentation (Literature Reviews, Clinical Performance Reports, EQA Analysis Reports) compliant with European In Vitro Diagnostics Regulations. Candidates should have a strong background in medical writing, preferably with experience in immunohistochemistry and cancer diagnostics.
Key Responsibilities:
Prepare technical documentation for In Vitro Diagnostic medical devices per European In Vitro Diagnostic Regulations and other country-specific regulatory requirements.
Draft performance evaluation plans, reports, analytical and clinical performance reports, and scientific validity reports.
Prepare declarations of conformity, summary of safety and performance reports for In Vitro Diagnostic devices.
Develop checklists for the standard assessment of legacy devices to identify regulatory updates needed.
Prepare labeling documents aligned with country-specific requirements.
Conduct and review systematic literature searches for medical scientific documents and related reports.
Review technical specifications, product design, and performance reports related to In Vitro Diagnostic products and medical devices.
Required Skills:
Strong background in In Vitro Diagnostics, preferably from clinical affairs or as a technical documentation reviewer for a European Notified Body.
Knowledge of companion diagnostics.
Expertise in External Quality Assessment (EQA) schemes and report analysis.
Experience with immunohistochemistry.
Skilled in clinical/medical writing, especially performance evaluations and clinical performance reports.
Expertise in statistics.
Specialized knowledge in therapy areas such as cancer diagnostics.
Experience managing in-house and/or external clinical studies.
What Cencora Offers
Benefit packages outside the US may vary by country and align with local market practices. Eligibility and effective dates may differ for team members covered under collective bargaining agreements.
Affiliated Company: DRA Consulting Oy
Equal Employment Opportunity:
Cencora provides equal employment opportunity without discrimination based on race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or other protected classes. Reasonable accommodations for disabilities are provided upon request during the employment process.
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