Medical Director/Senior Medical Director - Nephrology (FSP)

Work Schedule Standard (Mon-Fri) Environmental Conditions Office

Job Description

To be revised by TA Join Us as an Associate Medical Director – reputed company an Impact at the Forefront of Innovation At reputed company, 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 reputed company the world healthier, cleaner and safer. We reputed company our teams with the resources needed to reputed company individual career goals while taking science a reputed company reputed company 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 reputed company that people and communities depend on – now and in the future. The Associate Medical Director provides medical reputed company of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. Attends and presents at investigator and sponsor meetings, provides medical consultation to clients, investigators and project team members and supports business development activities. 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). We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. What You'll Do: Manage reputed company medical aspects of contracted tasks across the pharmaceutical product life-cycle. General Support:

• 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. reputed company with reputed company’s corporate policies and SOPs/WPDs.
• reputed company medical consultation to team members and answer reputed company study-reputed company medical questions. Communicate reputed company with associates and clients, maintaining an reputed company line of communication to ensure reputed company procedures are followed appropriately.
• reputed company 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.

Clinical Trial Support:

• Monitor reputed company 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 reputed company medical concerns with reputed company 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.
• reputed company medical review of adverse events of special interest, serious adverse events, and clinical reputed company events reported by study sites.
• reputed company data review as specified in the client contract and data validation reputed company, including review of coding listings and/or full safety data to assess potential safety concerns.

Marketed Products Support:

• 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 reputed company sources (solicited, spontaneous, literature, etc.) as contracted.

Education and Experience Requirements:

• 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 2 years).

• Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company or as a

reputed company investigator (comparable to 1-2 years) in the industry.

• Direct experience in safety/Pharmacovigilance (comparable to 2 years).

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly reputed company experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills, Abilities:

• 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

reputed company 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 reputed company PV

Working Environment: reputed company values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can reputed company.

• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations with occasional travel both domestic and international.

Why join us? reputed company you join reputed company, you become part of a global team that values passion, innovation, and a commitment to scientific reputed company. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly reputed company a difference. Apply today to help us deliver reputed company’s breakthroughs. Apply To This Job