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... with internal multidisciplinary stakeholders (Regulatory Affairs, Regulatory Operations, Worldwide Patient Safety, ... to support aRMM/REMS regulatory submissions Lead live meetings to adjudicate multiple ... in Pharmaceutical Industry (REMS Operations,..
... Safety group is responsible for pharmacovigilance and pharmacoepidemiology deliverables including single ... strategic oversight and delivery of medical safety assessment for the assets ... management of their team of..
... multidisciplinary RMP/REMS stakeholders (Submission teams, Lead Safety Physicians, Regulatory Affairs, Biostats, Regulatory Operations, Global Risk ... status reports for different audiences Lead status meetings to ensure transparency ... Industry..
... for defining and managing the Medical Affairs Strategy for the launch and ... studies and training/education for Regional Medical Affairs teams. This position is focused ... to provide strategic..
... to turning innovative science into medical solutions that bring value and ... our focus on addressing unmet medical needs and conducting our business ... Scope: Reports to the Group..
... results. Summary The Clinical Trial Lead works with stakeholders across the ... commercial objectives. The Clinical Trial Lead reviews and interprets clinical data, ... clinical overviews. In collaboration with..
... to turning innovative science into medical solutions that bring value and ... our focus on addressing unmet medical needs and conducting our business ... Working closely with the global..
... to turning innovative science into medical solutions that bring value and ... our focus on addressing unmet medical needs and conducting our business ... Scope: The Companion Diagnostic Director,..
... issues today and address the medical challenges of tomorrow. We strive ... and LinkedIn.The Therapeutic Area (TA) Lead is responsible for leading a ... in developing and executing the..
... the OpportunityThe IT Solutions Delivery Lead, Regulatory and Medical Affairs role is critical to ensuring ... Clinical Sciences, BioMetrics, Clinical Development/Operations, Pharmacovigilance, Regulatory, Medical Affairs, etc.u00A0 Your focus will..
... progressive non-viral liver diseases. Intercept's lead product, obeticholic acid (OCA), is ... activities as functional or technical lead, ensuring timelines, compliance and quality.nTrain, ... Clinical Research, Clinical Operations, Regulatory..
... and knowledge management Experience in pharmacovigilance and quality management system auditing, ... BPSQA audit program by providing pharmacovigilance and quality assurance expertise Support ... and suppliers that impact the..
... Theu202FAssociate Scientific Director / Associate Medical Directoru202Fis an emerging leadership position ... the Early Clinical Development Team lead. This includes developing key documents ... messagingu00A0Theu202FAssociate Scientific Director / Associate..
... PV advisor to Clinical Operations, Medical Affairs, Commercial and PV staffEnsures processes ... DSURs, IND Annual reports, etc.)Provides pharmacovigilance expertise to BioMarin and/or CRO/Vendor ... awareness, knowledge and understanding..
... Manager, Document Management SUPERVISOR GRM Lead, Publishing and Support DEPARTMENT Center ... Pharmaceutical experience in REMS Operations, Medical Communications/Medical Affairs, Regulatory, or Safety/Pharmacovigilance. REMS and Risk Management Plan .....
Job Description Medical Science Liaison (MSL), UK & ... progressive non-viral liver diseases. Intercept's lead product, obeticholic acid (OCA), is ... NASH, we are seeking a Medical Science Liaison (MSL)..
... to turning innovative science into medical solutions that bring value and ... our focus on addressing unmet medical needs and conducting our business ... ensure alignment and integration of..
... preparation, and safety monitoring.The Associate Medical Director is an emerging leadership ... the Clinical Science Therapeutic area lead or other Clinical Science leader. ... reports and key messagingThe Associate..
... to turning innovative science into medical solutions that bring value and ... our focus on addressing unmet medical needs and conducting our business ... management of a National Field..
Senior Director, Regulatory Affairs n nThis position is responsible ... supervising, and managing the Regulatory Affairs (RA) function. This includes Regulatory ... Regulatory Information, Technical Writing, and Pharmacovigilance. In addition..
