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- CMRM CorporationCubao 1109 P00
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- Dashlabs.aiQuezon City
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- SutherlandTaguig
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- Lexie Staffing & Business ConsultingBulacan
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Job Post Details
Medical Consultant Affairs
Cubao 1109 P00
PHP 45,000 - PHP 65,000 a month
-
Part-time, Permanent
Medical Consultant Affairs
Job details
PHP 45,000 - PHP 65,000 a month
Part-time, Permanent
Flextime
Cubao 1109 P00
Full job description
To serve the primary medical authority and regulatory liaison for the company. This role is responsible for the clinical justification of product registrations, the management of ACTD dossiers, and the direct “rationalization” of product efficacy and safety to the Philippine Food and Drug Administration (FDA).
Key Responsibilities:
- Labeling & Promotional Materials: Review and approve product labels, package inserts, brochures, and promotional materials.
- Training & Development: Support training programs for sales representatives, supervisors, pharmacists, and other relevant personnel.
- FDA Liaison & Advocacy: Act as the medical liaison with the FDA and relevant medical societies, including defending clinical data and product positioning during regulatory discussions.
- ACTD Dossier Management: Oversee the preparation and medical review of ACTD dossiers, particularly Part IV – Clinical Data, ensuring scientific and regulatory compliance.
- Clinical Trial Oversight: Develop and oversee pre- and post-marketing clinical trials and ensure compliance with Good Clinical Practice (GCP) in coordination with investigators and Ethics Committees.
- Regulatory Medical Clearance: Review and provide medical clearance for FDA communications and submissions involving new drugs and investigational drugs.
- Pharmacovigilance: Monitor and evaluate adverse drug reactions/events and ensure timely and accurate reporting to the FDA.
Required Qualifications (Based on FDA Guidelines)
- Must be a Doctor of Medicine (MD) duly registered with the Professional Regulation Commission (PRC).
- Finish a residency training program in a reputable medical facility or be a faculty member in a recognized medical school, preferably in pharmacology, for at least three (3) years of being employed by a pharmaceutical company.
- Must have satisfactorily earned the Diploma in Pharmaceutical Medicine or passed the examinations given by the specialty board of Pharmaceutical Medicines within three (3) years of being employed by any pharmaceutical company.
- Has a broad understanding of the regulatory environment, healthcare system, and market dynamics in the Philippines.
- Has excellent communication skills, good people management, and cross-functional collaboration skills.
- Has a disputable personal and work ethic.
Pay: Php45,000.00 - Php65,000.00 per month
Benefits:
- Additional leave
- Company Christmas gift
- Company events
- Flexible schedule
- Flextime
- Free parking
- On-site parking
- Opportunities for promotion
- Paid training
- Pay raise
- Promotion to permanent employee
- Work from home
Work Location: In person
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