Medical Director

2 weeks ago

Bengaluru, Karnataka, India Apotex Full time

About Apotex Inc.

As a leading global health company, Apotex produces high-quality, affordable medicines for patients worldwide. With a presence in over 75 countries, our medicines are accessible to millions. Our commitment to vertical integration enables us to develop and sell generic, biosimilar, and specialty products globally.

Job Summary

This role involves conducting studies in compliance with established standard operating procedures (SOPs), Good Clinical Practices (GCP), and regulatory guidelines. The primary focus is on ensuring the safety of study subjects.

Responsibilities

  • Conduct duties following SOPs, GCP requirements, and Safe Work Procedures.
  • Participate as Clinical Investigator/Principal Investigator for assigned BE studies or clinical trials.
  • Responsible for screening and in-study assessment, and medical care of all potential clinical volunteers/subjects.
  • Assess previous history, perform physical examination, including medical history of potential volunteers.
  • Judge lab reports and reviews applicable clinical reports as required.
  • Complete study participation summary.
  • Review subject eligibility to conform with protocol requirements.
  • Confirm subject comprehension of study activities and ensure informed consent prior to entry into study.
  • Oversee and assist in administering test articles.
  • Assess subjects' adverse events and provide medical follow-up in consultation with Principal investigator.
  • Handle adverse events concerning subject safety.
  • Provide medical counseling to volunteers/study subjects with abnormal screening results and post-dose out-of-range results.
  • Withdraw subjects as necessary to protect subject safety.
  • Review subject monitoring and safety data during study conduct.
  • Handle medical emergencies and approve use of on-site emergency medical equipment for adverse event follow-up.
  • Assist in creating, developing, and revising Clinical Operations Department SOPs.
  • Supervise Nurses and Duty Medical Officers for rendering medical services to subjects at the Clinical Facility.
  • Evaluate personal adherence with compliance programs, including Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
  • All other relevant duties assigned.

Requirements

  • Education: M.B.B.S/M.D.
  • Knowledge, Skills and Abilities: Current experience in patient care; Familiarity with TPD, FDA ICH, and EU Guidance's with respect to bioequivalence studies or clinical trials would be an asset.
  • Experience: Minimum of 3-4 years' experience.

Estimated Salary:$120,000 - $150,000 per year

At Apotex, we value diversity and inclusion, providing an accessible work environment where all employees feel valued and respected.

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