Morristown, NJ30+ days ago
Understanding of pharmaceutical product development and life cycle management gained through ~4 years of clinical development and medical experienceExcellent Scientific and medical / clinical expertiseExcellent expertise in clinical development and methodology of clinical studiesExcellent communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agenciesDemonstrated capability to challenge decision and status quo with a risk-management approachAbility to negotiate to ensure operational resources are available for continued clinical conductFluency in written and spoken EnglishExcellent Teaching skills, demonstrated ability to assist and train othersAbility to work within a matrix modelInternational/ intercultural working skillsOpen-minded to apply new digital solutions. pressure test and cluster feasibility, medical review and validation of clinical data, study risk assessment)Contribute to the clinical part of submission dossier for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China and answers to questions from health authoritiesProvide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigatorsBe the medical reference in the Clinical Study team, ensuring the medical relevance of the clinical dataInteract with other CRDs in the project, Global Project Head, The PV Rep, Regulatory and other key functional reps.