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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 in Medical Affairs works independently under limited supervision and applies their subject matter expertise to meet specific needs and requirements within the organization. This role focuses on clinical trials, research activities, and the application of medical affairs knowledge.


Main Responsibilities

  • Clinical Trial Oversight: Take a leadership role in overseeing the planning, execution, and data collection activities for clinical trials, specifically for phases III & IV of company products under development.

  • Protocol Implementation & Reporting: Contribute to the implementation of clinical protocols, ensuring their adherence and facilitating the timely completion of final reports.

  • Investigator Recruitment & Negotiation: Recruit clinical investigators, negotiate study designs, and manage the financial aspects of clinical trials, including costs.

  • Human Clinical Trials Management: Direct and oversee human clinical trials, ensuring compliance with regulatory standards and achieving project milestones.

  • Adverse Event Monitoring: Participate in the monitoring of adverse events and safety reporting to ensure that any potential risks are appropriately addressed.

  • Regulatory Reporting: Coordinate and provide accurate information for reports submitted to regulatory agencies to ensure compliance with legal and ethical standards.

  • Protocol Adherence & Study Completion: Monitor adherence to clinical protocols at trial sites, assess overall study progress, and determine when a study is ready for completion.

  • Investigator Initiation: Coordinate and oversee investigator initiation meetings and ensure successful study launches.

  • Consultant/Liaison Role: May act as a consultant or liaison with other companies when working under licensing agreements, offering expertise and guidance on clinical matters.


Qualifications

Education:

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

Experience:

  • Minimum Experience: 1 year of relevant experience in medical affairs or clinical trials, specifically in a role overseeing or managing clinical research and trials.


This position offers an opportunity for professionals with clinical trial and medical affairs experience to apply their skills in managing complex projects. If you are an experienced individual with a passion for clinical trials and regulatory compliance, we encourage you to apply.