5 jobs found in West Reading, PA

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. The Medical Evaluator provide clinical expertise on all aspects of individual case assessments with special emphasis on ongoing evaluation of safety information during late-stage development and post marketing. You will apply sound medical judgment for analysis and interpretation of clinical safety data. Strong product knowledge is needed for success in the role.  The role ensures that the medical aspects of individual cases: Comply with legal requirements and company standards of the PV (Pharmacovigilance) tasks and responsibilities. Provide Key information to prevent harm from adverse reactions in humans arising from the...

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. The Associate Director Clinical Operations Lead is accountable for the development of the operational strategy for a clinical study(ies) and/or a clinical program (s) as well as the end-to-end study management and delivery of all operational activities and budget management relating to assigned clinical study (ies)/program(s). This role must be experienced in working in a matrix environment (internal and external partners) with cross-functional responsibilities associated with trial execution and overall therapeutic area clinical development planning. This role typically manages one or more studies/or products,...

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. You will oversees all areas of single case processing in the global pharmacovigilance database from all sources. This includes ensuring that the vendor performs case processing in accordance with regulatory guidelines, PV agreements, and the Company's SOPs, as well as responding to specific questions or queries about cases. This role develops standards and processes, with a focus on global compliance and process optimization. Oversees Medical Evaluators responsible for medical review of ICSRs. Key Responsibilities Oversight of Case Management Processes activities Oversight of Medical Evaluator role which...

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. The Director Clinical Operations Lead is accountable for the development of the operational strategy for a clinical study(ies) and/or a clinical program (s) as well as the end-to-end study management and delivery of all operational activities and budget management relating to assigned clinical study (ies)/program(s). Responsibilities encompass support to the development of the operational strategy for our most complex studies and ensuring achievement of all program goals within established timelines, budget, and quality standards, and according to the TA strategies. This role must be experienced in working in a...

The Director, Medical Affairs Statistics will support product marketing by generation of scientifically valid evidence that goes beyond the product label. The successful incumbent will serve the knowledge needs of patient and prescriber communities that go beyond the targeted focus of regulators. Responsibilities and Accountabilities: Advising, planning and execution of exploratory analyses for secondary publications Input in CRO selection and participation in governance; direct and supervise programmers and CROs in the execution of exploratory analyses Statistical leadership and strategic partnering with key stakeholders for the design and analysis of registry trials and RWE (Real World Evidence) studies initiated by the commercial organization, including building strong relationships with quantitative counterparts in key partner organizations Statistical leadership and strategic partnering with key stakeholders for life-cycle-management (LCM) clinical trials...