Company Description

ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.

Job Description

The Medical Monitor serves as the primary medical point of contact for a project or study. The Medical Monitor effectively performs and manages medical and safety review, processes, and projects for assigned clinical and post marketing products.

Essential Functions Include:

• Directs the management of medical monitoring during the course of clinical trials and projects and performs all aspects of clinical trial medical monitoring.
• Completes the medical review of key clinical documents, individual case safety reports, and medical or safety-related regulatory documents.
• Provides support and input into the planning, design, preparation, initiation, and execution of study protocols and other required documentation in compliance with project plans, federal regulations, GCP, and good medical practice.
• Manages the evaluation and selection of investigators and study sites as well as analysis of medical activities.
• Reviews, edits, and oversees medical and safety sections of regulatory document submissions.
• Participates in Investigator’s meetings as needed.

Qualifications

Qualified candidates must have:

• A Doctor of Medicine (MD) and preferably board certified in the United States.
• A minimum of 5 years of clinical research and management experience in the pharmaceutical industry.
• Excellent understanding of the clinical / pharmaceutical process so as to effectively communicate and create required deliverables.
• Advanced knowledge of, and ability to, apply GCP and all applicable regulations and guidelines.
• Exceptional leadership skills and proven industry vision.
• Ability to understand complex clinical and statistical data and issues from an analytical standpoint.

• Effective negotiation and interpersonal communication skills to interact with a variety of peers and constituents.
• Track record of execution on large scale programs that meet quality, time, and budget requirements.

Additional Information

All candidates must be legally eligible to work in the United States.

We are an equal opportunity employer. M/F/D/V

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***