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Regional Medical Advisor

1+ years
Not Disclosed
10 Dec. 14, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Experienced Professional - Medical Affairs

Location: [Insert Location]


Main Purpose of the Role

The Experienced Professional - Medical Affairs works under limited supervision and applies subject matter expertise in Medical Affairs. The role requires the capacity to apply knowledge and skills to meet the specific needs and requirements within the department, contributing to clinical trials, research activities, and data collection efforts.


Main Responsibilities

  • Clinical Trials & Research: Oversee the planning, execution, and data collection activities for clinical trials and research projects, primarily focusing on phases III & IV for company products under development.

  • Protocol Implementation: Contribute to the implementation of clinical protocols and facilitate the completion of final reports to ensure compliance and quality.

  • Investigator Recruitment: Recruit clinical investigators for clinical trials and negotiate study design, protocols, and costs.

  • Human Clinical Trials Management: Direct and oversee human clinical trials, ensuring adherence to study plans and achieving study completion objectives.

  • Adverse Event Monitoring: Participate in adverse event reporting and safety responsibilities monitoring to ensure patient safety and regulatory compliance.

  • Regulatory Reporting: Coordinate and prepare reports submitted to regulatory agencies, ensuring that all necessary information is accurate and timely.

  • Study Oversight: Monitor adherence to clinical protocols, determine study progress, and ensure successful completion of trials.

  • Investigator Initiations: Oversee and coordinate investigator initiation meetings and group studies, ensuring proper study setup and communication.

  • Consulting & Liaison: Serve as a consultant or liaison with other corporations, especially when working under licensing agreements or external partnerships.


Qualifications

Education:

  • Education Level: Associate's Degree (± 13 years of education).

Experience:

  • Minimum Experience: 1 year of relevant experience in medical affairs, clinical trials, or a similar area.


This role provides an opportunity for experienced professionals to play a key role in the planning and execution of clinical trials, ensuring compliance with protocols and contributing to the advancement of the company’s products. If you meet the experience requirements and are ready to take on responsibility for significant clinical trials, we encourage you to apply.