5 pharmacy liaison jobs found

CSL CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. Could you be our next PV Assessment Lead and MSPR? The job is in our King of Prussia, PA Office. This is a hybrid position and is onsite three days a week. You will report to the Head of MSPR. You will be responsible for preparing adequate Pharmacovigilance assessments in the course of GMP deviation investigations, complaint investigations and other reports (e.g. BPDR, Monthly PV report to manufacturing site QA, PQR and APQR) on a high scientific level and in close cooperation with relevant stakeholders (e.g. Global Safety Lead, PTC team, QA managers). The position holder is responsible for the management and...

CSL Strategic Leadership & Team Development Build, lead, and develop a high-performing team of Medical Outcome Specialsts across geographies in the US Define the strategic vision, annual priorities, and operating model for the Medical Value and Access function Establish performance management frameworks, competency models, and development pathways Foster a culture of scientific excellence and compliance, oriented to impact, not just activities. Develop training programs on payer landscape, value communication, health economics, and compliant engagement Value Tools & Evidence Translation Partner with HEOR to co-develop and refine budget impact models, cost-effectiveness analyses, and value dossiers Translate clinical trial data and real-world evidence into payer-relevant value narratives Oversee development and deployment of interactive value tools for field use Identify evidence gaps from payer interactions and feed insights into...

CSL The Lead, Global Regulatory Affairs Device is responsible for: Developing, coordinating and implementing global Software as a Medical Device regulatory strategies for new combination and standalone medical devices. Ensure worldwide regulatory device compliance and successful market access across all regions. Closely collaborate with internal stakeholders on regulatory strategy issues, develop approaches to address regulatory and compliance matters, serve as primary liaison to the US FDA for device matters, and closely work regional regulatory staff to engage with international health authorities. Represening CSL in official device regulatory capacities and acting as an authorized official or responsible person in interactions with regulatory agencies. This role promotes strong cross-functional collaboration and effective communication across Global Operations, Plasma Operations, R&D, Global Regulatory Affairs, and other relevant CSL business functions to...

CSL The Lead, Global Regulatory Affairs Device is responsible for: Partnering closely with R&D, Manufacturing, Operations, Quality, and Regulatory Affairs stakeholders to address regulatory strategy challenges and deliver innovative, timely regulatory solutions that meet evolving device regulatory and compliance requirements for plasmapheresis devices, drug device combination products, standalone drug delivery devices, and ancillary devices. Ensure worldwide regulatory device compliance and successful market access across all regions. Closely collaborate with internal stakeholders on regulatory strategy issues, develop approaches to address regulatory and compliance matters, serve as primary liaison to the US FDA for device matters, and closely work regional regulatory staff to engage with international health authorities. Represening CSL in official device regulatory capacities and acting as an authorized official or responsible person in interactions with...

CSL Position Purpose The Head of Global Regulatory Affairs Device is responsible for: Providing strategic leadership and operational oversight for the Global Regulatory Affairs Device function. Leading the global regulatory strategy and execution for CLS's medical device portfolio during development and post-approval lifecycle, including plasmapheresis devices, blood establishment computer software (BECS), drug device combination products, standalone drug delivery devices, ancillary devices, and software as/in a medical device (SaMD/SiMD). Ensure worldwide regulatory device compliance and successful market access across all regions. Closely collaborate with internal stakeholders on regulatory strategy issues, develop approaches to address regulatory and compliance matters, serve as primary liaison to the US FDA for device matters, and closely work regional regulatory staff to engage with international health authorities. Represening CSL in official...