Medical Consultant Affairs
# Medical Consultant Affairs **CM Star Corporation** · Quezon City Central Post Office 1173 P00 · `On-site` 🕒 **Статус:** *Опубликовано: 6 дней назад* · *Источник: Indeed* --- ### About the Role 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: Approval of all package inserts, labels, brochures, and other labeling and promotional materials. Training & Development: Assistance in the training program of professional sales representatives, supervisors, pharmacists, and other personnel of the drug establishment. FDA Liaison & Advocacy: Serve as the official liaison officer with the FDA and relevant medical specialty societies. You will lead “rationalization” meetings with FDA evaluators to defend clinical data and product positioning during the registration process. ACTD Dossier Management: Oversee the preparation and review of the ASEAN Common Technical Dossier (ACTD), with a focus on Part IV (Clinical Data). Ensure that clinical overviews and summaries are scientifically sound and meet ASEAN harmonization standards. Clinical Trial Oversight: Prepare, adopt, and implement clinical trial protocols for pre- and post-marketing phases. Coordinate with the investigators and Research Ethics Committees (RECs) to ensure compliance with Good Clinical Practice (GCP). Regulatory Submission Clearance: Review and provide medical clearance for all communications with the FDA regarding New Drugs and Investigational New Drugs (IND). Pharmacovigilance: Identify and monitor adverse drug reactions/events, ensuring appropriate reports are prepared and submitted to the FDA in a timely manner. Required Qualifications Must be a Doctor of Medicine (MD) duly registered with the Professional Regulation Commission (PRC). Finishes a residency training program in a reputable medical facility or is 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 disputable personal and work ethics. Specialization Completion of a residency training program or a faculty position in a recognized medical school (preferably in pharmacology or clinical pharmacology) for at least 3 years. Must have earned a diploma in pharmaceutical medicine or passed the specialty board examinations within 3 years of employment. Specific Expertise FDA Network: Proven track record of navigating FDA registration pathways and established professional rapport with regulatory evaluators. ACTD Proficiency: Deep technical knowledge of the ACTD structure and the specific requirements for pharmaceuticals for human use. Clinical Research: Hands-on experience in designing or managing Multi-Regional Clinical Trials (MRCTs) and filing Investigational New Drug (IND) applications. Pay: Php45,500.00 - Php55,961.49 per month Benefits: Company Christmas gift Company events Flexible schedule Free parking On-site parking Pay raise Work Location: In person
Наблюдалась 2026-09-15, впервые 2026-09-09, найдена на 2 площадках, источник — Indeed.