Senior Medical Director- Nephrology
Adecco US, Inc.
Adecco Healthcare & Life Sciences is hiring a remote contract Senior Medical Director- Nephrology for our Pharmaceutical partner based out of Alachua, FL.
The anticipated hourly wage for this position is between $125 and $129.65. Hourly wage may depend upon experience, education, geographic location, and other factors.
**Summarized Purpose:**
Provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. Provides medical review and analysis for clinical trial serious adverse events, marketed products ICSR and periodic safety reports (e.g. PBRER, PSUR, DSUR) as well as other client deliverables (e.g. labeling reconciliation documents, CTD modules, REMS, RMP and CSR).
+ Manages all medical aspects of contracted tasks across the pharmaceutical product life cycle.
+ Provides medical consultation to team members and answer all study related medical questions. Communicates clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately.
+ Provides therapeutic training and protocol training on assigned studies, as requested.
+ Monitors all safety variables (AE, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medication for protocol restrictions, and un-blinding requests) of clinical studies.
+ Manages signal detection activities, scientifically reviews aggregate reports, contributes to label updates, supports dossier maintenance and risk management activities.
**Education and Experience:**
+ MD or equivalent required. Active medical licensure preferred.
+ Candidates should have at least one of the following:
+ Clinical experience in treating patients in the specialty or sub-specialty associated with the applicants training (comparable to 3 years)
+ Or Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company or as a principal investigator (comparable to 3-5 years) in the industry
+ Or direct experience in safety/Pharmacovigilance (comparable to 3 years).
+ Therapeutic expertise across one or more medical specialty or sub-specialties
+ Working knowledge of relevant safety databases (e.g. Medra)
+ Fluent in spoken and written English
+ Understanding guidelines (FDA, ICH, EMA and GCP)
+ Working knowledge of biostatistics, data management, and clinical operations procedures
Benefit offerings include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State, or local law; and Holiday pay upon meeting eligibility criteria.
**Pay Details:** $123.00 to $125.00 per hour
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity Employer/Veterans/Disabled
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.adecco.com/en-us/candidate-privacy
The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
+ The California Fair Chance Act
+ Los Angeles City Fair Chance Ordinance
+ Los Angeles County Fair Chance Ordinance for Employers
+ San Francisco Fair Chance Ordinance
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