Medical Director/Sr Medical Director - Neurology Job at myGwork

Job Description

Join Us as a Medical Director – Make an Impact at the Forefront of Innovation. At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Job Responsibility

Manage all medical aspects of contracted tasks across the pharmaceutical product life-cycle
Ensure tasks delegated to PV are properly executed
Adhere to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues
Follow client SOPs/directives and project-specific WPDs for assigned projects
Comply with CRG’s corporate policies and SOPs/WPDs
Provide medical consultation to team members and answer all study-related medical questions
Communicate clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately
Provide therapeutic training and protocol training on assigned studies, as requested
Assist in writing (interpretation of safety and efficacy data) and/or reviewing CSR, IND/NDA reports, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc., to ensure that the medical content is accurate and complete
Monitor 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
Discuss all medical concerns with principal investigators and clients (e.g., interpretation of inclusion/exclusion criteria) raised during the course of a study, using proper medical judgment in interpretation and decision-making regarding clinical situations as they relate to the investigational study
Provide medical review of adverse events of special interest, serious adverse events, and clinical outcomes events reported by study sites
Perform data review as specified in the client contract and data validation manual, including review of coding listings and/or full safety data to assess potential safety concerns
Manage signal detection activities, scientifically review aggregate reports, contribute to label updates, and support dossier maintenance and risk management activities
Medically review adverse event and serious adverse event data from all sources (solicited, spontaneous, literature, etc.) as contracted

Requirements

MD or equivalent required
Active medical licensure preferred
Clinical experience in treating patients in the specialty or sub-specialty associated with the applicants training (comparable to 2 years), i.e. Neurology Residency/Fellowship
Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company or as a principal investigator (comparable to 1-2 years) in the industry
Direct experience in safety/Pharmacovigilance (comparable to 2 years)
Therapeutic expertise across one or more medical specialty or sub-specialties
Strong decision-making, problem solving, organizational skills and analytical skills
Excellent oral and written communication skills
Working knowledge of relevant safety databases (e.g. Medra)
Flexibility to travel domestically and internationally
Ability to work independently, analyze work with attention to detail, process and prioritize sensitive complex information
Proficiency in basic computer applications
Fluent in spoken and written English
Excellent interpersonal, influencing and team building skills
Understanding guidelines (FDA, ICH, EMA and GCP)
Working knowledge of biostatistics, data management, and clinical operations procedures
Ability to act as a mentor/trainer to other staff within PV

myGwork - LGBTQ+ Business Community - All Job Offers

Select Country

Medical Director/Sr Medical Director - Neurology

Job Description

Job Responsibility

Requirements

Looking for more opportunities?

Medical Director/Sr Medical Director - Neurology

Ai Engineer

Branch Manager

Guest Environment Expert

Project Engineer

Sales Assistant

Sales / Project Estimator

Human Resources Coordinator

Showroom Sales Assistant - Flexible Hours

Our AI answers in your language