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Medical Advisor / Associate Medical Director / Medical Director (Nephrology) - Argentina (R1053999) in Buenos Aires, Argentina at IQVIA™

Date Posted: 2/4/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Experience:
    Not Specified
  • Date Posted:
    2/4/2019
  • Job ID:
    R1053999

Job Description

Therapeutic Strategy has an exciting opportunity within NEPHROLOGY.  Let your career soar with IQVIA!

The Medical Advisor / Associate Medical Director /  Medical Director will provide medical, clinical and scientific advisory expertise to all IQVIA divisions as requested. Participate in all aspects of Medical Science involvement on assigned trials. Serve as a medical expert during project delivery lifecycle. Provide therapeutic and medical expertise to business development activities.

RESPONSIBILITIES:

The role includes both Medical Monitoring responsibilities and Medical Strategic inputs. The function that should represent the primary focus will be communicated.

Medical Monitoring:

  • Primarily serves as Global Medical Advisor on assigned projects.
  • Serves as Scientific Advisor and provides guidance to Project Leaders on the medical and scientific aspects of assigned projects.
  • Provides medical support to investigative sites and project staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility.
  • Performs medical review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs).
  • Provides therapeutic area/indication training for the project clinical team.
  • Attends and presents at Investigator Meetings.
  • Performs review and clarification of trial-related Adverse Events (AEs).
  • May perform medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narrative, in collaboration with the Pharmacovigilance department.
  • May provide medical support for the Analysis of Similar Events (AOSE), in collaboration with or on behalf of Pharmacovigilance department.
  • May perform medical review of adverse event coding.
  • Performs review of the Clinical Study Report (CSR) and patient narratives.
  • Attends Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
  • Available 24 hours per day, 7 days per week to respond to urgent protocol-related issues at the investigative sites.

Medical Strategy:

  • Provides expert advises to the development of medically sounded delivery strategies for small to large and/or complex multi-region studies in partnership with sales and other functions responsible for business development activities.
  • Responsible for the development of the medically related aspects of client proposals including the budget related to medical monitoring.
  • Provides medical and scientific advises to key internal stakeholders developing proposals: this may include, but is not limited to, reviewing the protocol for scientific/regulatory soundness and feasibility, identification of target site and principal investigator profiles, anticipated patient recruitment, standard of care and competitive landscape.
  • Attends and presents at bid defense meeting, as required.
  • Participates in strategic business development activities including presentations to prospective clients.
  • Maintains awareness of industry development and may author related publications.
  • May serve as Regional/Multiregional/Global Therapeutic Lead for specific indication(s).

QUALIFICATIONS

-Medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education, along with a medical license, or equivalent, from the country or region in which he/she resides and works is required.

-Minimum of 5 years' experience in clinical medicine, in addition to 1-4 years' clinical trials experience as an investigator or in the Pharma, CRO, or Biotech industry.

-Specialty Board certification in Nephrology.

-English: advanced (oral/written).

  • Robust and current knowledge of scientific, clinical, regulatory, commercial and competitive landscape in applicable therapeutic area.
  • Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research.
  • Strong communication, presentation and interpersonal skills, including good command of English language (both written and spoken).
  • Business Acumen.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.
  • Proven skills in providing consultation and advice on multiple assignments are required, as well as initiative and flexibility.
  • May require regular travel.
  • Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
  • Extensive use of keyboard requiring repetitive motion of fingers.

EEO Minorities/Females/Protected Veterans/Disabled



Job ID: R1053999