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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

Location: [Insert Location]


Main Purpose of the Role

The Clinical Research Professional in the Medical Affairs Sub-Function is an experienced individual contributor who works with limited supervision. This role leverages subject matter expertise in Medical Affairs, particularly in overseeing clinical trials, data collection activities, and the implementation of clinical protocols.


Main Responsibilities

1. Clinical Trial Oversight and Execution

  • Study Planning and Execution: Oversee the planning, execution, and direction of clinical trials, particularly phases III & IV for company products under development.

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

  • Adherence Monitoring: Monitor study progress to ensure adherence to protocols and determine study completion criteria.

2. Investigator Recruitment and Study Design

  • Investigator Recruitment: Recruit clinical investigators for studies and negotiate study design and costs.

  • Study Initiation: Coordinate and oversee investigator initiations, ensuring that study protocols are clearly communicated and understood.

3. Safety and Reporting

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

  • Regulatory Submissions: Coordinate the gathering and provision of reporting information for regulatory submissions and communications.

4. Collaboration and Consulting

  • Liaison with Other Corporations: Act as a consultant and liaison with other corporations, particularly when working under licensing agreements.

  • Study Coordination: Work with internal teams and external stakeholders to ensure the successful coordination of group studies.


Qualifications

Education:

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

Experience/Background:

  • Minimum Experience: At least 1 year of relevant experience in clinical trials and Medical Affairs.

  • Clinical Trial Knowledge: Experience in overseeing and executing clinical trials, especially in phases III and IV.

  • Regulatory Knowledge: Familiarity with clinical trial protocols, adverse event monitoring, and regulatory reporting requirements.


This role offers the opportunity to contribute to the successful management and execution of clinical trials, as well as the development of key insights within Medical Affairs. If you're experienced in clinical trial management and passionate about advancing pharmaceutical research, this position could be a great fit.