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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: Clinical Research Professional – Medical Affairs

Main Purpose of the Role

This role is for an experienced individual contributor who works under limited supervision. The position requires applying subject matter expertise in the field of Medical Affairs, particularly in overseeing clinical trials and research activities. The professional must demonstrate the ability to apply skills and knowledge to meet specific needs or requirements within the company’s clinical development processes.


Main Responsibilities

1. Clinical Trial Management and Execution

  • Trial Oversight: Oversee the direction, planning, and execution of clinical trials, particularly in phases III & IV for products under development.

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

  • Study Compliance: Monitor adherence to protocols and determine when a study is complete, ensuring all regulatory and procedural standards are met.

2. Investigator Recruitment and Study Design

  • Investigator Recruitment: Recruit clinical investigators for studies and negotiate the design and costs associated with these studies.

  • Study Coordination: Coordinate and oversee investigator initiations, ensuring all requirements are met for smooth study implementation.

3. Safety Monitoring and Reporting

  • Adverse Event Monitoring: Participate in the monitoring and reporting of adverse events and safety responsibilities during clinical trials.

  • Regulatory Reporting: Provide and coordinate reporting information for regulatory submissions and ensure that the necessary documentation is in place for regulatory agencies.

4. Cross-functional Collaboration

  • Consulting and Licensing: Act as a consultant and liaison with other corporations when working under licensing agreements, ensuring effective collaboration and understanding of study requirements.

  • Study Coordination: Coordinate and manage group studies, facilitating communication between investigators and other involved stakeholders.


Qualifications

Education:

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

Experience/Background:

  • Minimum Experience: At least 1 year of experience in clinical research, specifically in the execution of clinical trials.

  • Clinical Trial Knowledge: Experience in phases III & IV of human clinical trials.

  • Adverse Event and Safety Monitoring: Familiarity with adverse event reporting and safety monitoring during clinical trials.


This role offers the opportunity to contribute to the advancement of clinical research in the Medical Affairs sector, managing critical aspects of clinical trials and collaborating with internal teams and external partners. If you have experience in overseeing clinical trials and are looking to grow in a challenging, rewarding environment, this position could be an excellent fit for you.