Remote Regulatory Medical Writer Jobs in Raleigh, NC

Job Posting Title- Medical Director, Rheumatologist

Location: Home-based in the U.S.

Job Overview

The Medical Director will be the medical expert on the IQVIA team working on a clinical research trial. This involves applying medical and scientific knowledge and expertise in support of the trial. These clinical trials will cover the full range of rheumatologic disorders.

Essential Functions

The role includes predominantly Medical Monitoring responsibilities with Medical Strategic input involvement as requested.

Medical Monitoring:

• Primarily serves as Medical Monitor (at the global or regional level) on assigned clinical trials.
• Serves as Scientific Advisor (providing medical advice and input) 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: patients eligibility, adverse events management, patients disposition, etc.
• 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).
• Attends Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
• Available to respond to urgent protocol-related issues at the investigative sites.

Medical Strategy:

• Contributes to the development of the medically related aspects of client proposals including the budget related to medical monitoring.
• Provides medical and scientific advice and guidance to key internal stakeholders developing proposals: this may include reviewing the protocol for scientific/regulatory soundness and feasibility, identification of target site and principal investigator profiles.
• Attends and presents at bid defense meetings, as required.
• Requires 30% periodic regional and international travel.

Qualifications

• Medical degree from an accredited and internationally recognized medical school.
• Board certified in Rheumatology
• Candidate should have a minimum 3 years clinical trials experience as a medical /clinical expert in the Pharma, CRO, or Biotech industry.
• Experience in immunology clinical trials as Medical Director, specific SLE experience is preferable
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Strong communication, presentation and interpersonal skills, including good command of English language (both written and spoken).
• Robust and current knowledge of scientific, clinical, regulatory, commercial and competitive landscape in Rheumatology.
• Proven skills in providing consultation and advice on multiple assignments are required, as well as initiative and flexibility.
• Availability for intermittent domestic and foreign travel to support these business assignments.

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IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more athttps://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is $154,900.00 - $431,500.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.