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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

Main Purpose of Role

The role involves an experienced professional who works under limited supervision, applying subject matter expertise in Medical Affairs. The individual is responsible for overseeing clinical trials and research, ensuring the appropriate application of skills and knowledge to meet the specific needs of the organization.


Main Responsibilities

  • Clinical Oversight: Manages and contributes to the direction, planning, and execution of clinical trials, ensuring effective data collection and research activities.

  • Protocol Implementation: Contributes to the development and implementation of clinical protocols and supports the completion of final reports.

  • Investigator Recruitment: Recruits clinical investigators, negotiates study design, and manages study costs.

  • Clinical Trials Management: Directs human clinical trials (phases III & IV) for company products under development.

  • Safety Monitoring: Participates in adverse event reporting and monitors safety responsibilities associated with the trials.

  • Regulatory Reporting: Coordinates and provides necessary reporting information for submissions to regulatory agencies.

  • Protocol Compliance: Monitors adherence to study protocols, ensuring that the studies reach completion.

  • Study Oversight: Coordinates and oversees investigator initiations and group studies.

  • Consulting Role: May act as a consultant or liaison when working under licensing agreements with other corporations.


Qualifications

  • Education: Associates Degree (or equivalent, approximately 13 years of education).

  • Experience: Minimum of 1 year of relevant experience in clinical trials or medical research.