Job Description

Job Overview:

The Senior Medical Reviewer provides medical input and medical review of moderate to complex clinical documents as Manuscripts. Abstracts, Posters, Advisory Board Meeting (ABM) reports, CSRs, Clinical and Nonclinical Overviews, Clinical and Nonclinical Summaries, IBs, Protocols, Product Monographs, Medico-marketing and training material. Provides oversight for medical information services. Provides medical review of safety documents (aggregate safety reports and signal detection), if needed. Develops and delivers training in disease states and protocol-specific requirements.

Summary of Responsibilities:

Performs medical data review - Reviews laboratory values, adverse events, coding dictionaries and data tables, listings, and figures, as needed. Provides medical inputs into moderate to complex clinical and regulatory documents such as CSRs, IBs, protocols, Clinical and Nonclinical Overviews and Summaries, Manuscripts, Abstracts, Posters, ABM Reports, Product Monographs, training material and safety documents such as aggregate safety reports and signal detection, as needed. Provides oversight for Medical Information services of the company. Provides training in disease states and protocol specific requirements across the region. Participates in training opportunities to advance knowledge of drug development and good clinical practice guidelines. Identifies process and implementation issues/gaps needing attention and provides input into necessary remediation. Assists in the development of protocols and in the review and revision of protocols, case report forms, project specific tools and clinical trial reports. And all other duties as needed or assigned

Qualifications (Minimum Required):

MBBS or MD with some clinical experience. Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required):

Physician (M.B.B.S. /MD) with some clinical experience. Minimum of 3-4 years' experience in pharmaceutical industry/ CRO in clinical research, medical services, medical writing (including medical communications). Experience in authoring and /or review of complex clinical documents such as CSRs, IBs, Protocols, Clinical Overviews and Summaries, Product Monographs, Training material, Publications. Medical and therapeutic area knowledge. Ability to evaluate, interpret, analyze, and critically discuss preclinical, clinical and safety data on healthcare products. Knowledge of regulatory requirements for structure and contents of clinical and regulatory documents. Good understanding of regulatory requirements and ICH/professional guidelines related to drug development, clinical research, medical information, clinical trial reporting, and publications. Excellent written and verbal communication skills. Proficiency using MS Office suite of applications.

Physical Demands/Work Environment:

Travel required.

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