6 jobs found in Langhorne, PA

The Role: Acts as Case Management subject matter expert in cross-functional teams for assigned clinical trials.  Manages  case management activities for assigned clinical studies to ensure compliance with national and international regulations, such as GxP guidelines and/or other relevant international and national legislation, regulations, guidance, and company policies and procedures within the area of responsibility. Manages the delivery of the Safety Reporting Plans, ; identifies, implements, and monitors KPIs/KQIs across clinical case management activities; Supports the preparation and conduct of PV and other GxP inspections and audits, as required, . Establishes, maintains, and/or ensures maintenance of  clinical trial case management required documents, such as safety reporting plans and reporting responsibilities  , in line with international and national regulations, guidelines, and internal standards. Oversee the Vendors to ensure GSPV...

The Associate Director Clinical Trial Disclosure and Transparency is a global subject matter expert responsible for ensuring timely, accurate, and compliant clinical trial disclosures across all regions and study types (interventional and observational). This role guides global strategy, drives process excellence, and oversees the delivery of clinical trial disclosure activities including registration, results disclosure and layperson summaries while providing support for transparency activities including anonymization and redaction of commercially confidential information (CCI) as required for business continuity and operational needs.  All activities and deliverables must be conducted in alignment with international regulations, CSL policies, industry standards and transparency requirements. Key Responsibilities Strategic Oversight & Compliance Lead enterprise clinical trial disclosure and transparency strategy and advise therapeutic areas and Medical Affairs on...

The Senior Manager, Clinical Operations FSP Resource & Vendor Management sits within the Clinical Operations organization and is accountable for the end‑to‑end oversight, planning, and optimization of FSP resources supporting Clinical Operations functions. This role owns the Clinical Operations FSP workforce model, ensuring the right capabilities, capacity, and timing of resources to support portfolio delivery. The role serves as the primary Clinical Operations interface to FSP vendors and works in close partnership with the POE organization, which retains accountability for enterprise‑level contracting, sourcing strategy, and overall vendor governance. The role enables effective decision‑making by balancing operational demand, cost, quality, and scalability, while ensuring alignment between Clinical Operations needs, POE frameworks, and vendor delivery. Work Environment: *** This is a hybrid position based onsite at any of the posted locations with a minimum of 3 days...

The Senior Manager GRA CMC Combination Product and Stand Alone Medical Device Specialist 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...

The Opportunity: The Senior Director, Medical Affairs, Hematology Pipeline is a senior-level global leadership role responsible for architecting and executing the end-to-end Medical Affairs pre-launch and peri-launch strategy for a high-priority hematology asset. This role serves as the primary Medical Affairs point of accountability for pipeline readiness, leading a team of four direct reports across US and International regions and collaborating extensively with cross-functional enterprise partners. The successful candidate will bring deep hematology expertise, launch experience, and the strategic acumen to translate scientific evidence into compelling, compliant medical narratives that position the asset for successful market entry. The Role: Global Pre-Launch & Peri-Launch Strategy: Lead the design and execution of a comprehensive global Medical Affairs pre-launch plan, ensuring alignment across US and International regions and readiness for peri-launch...

CSL's 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 Associate Director, Medical Affairs (Transplant and Immunology)? The job is in our King of Prussia, PA or Waltham, MA Office. This is a hybrid position and is onsite three days a week. You will report to the Senior Director, Medical Affairs, Transplant & Immunology. You will contribute to the development of medical strategy for assigned inline products in Transplant & Immunology and drive the execution of Medical Affairs plans across the post-launch product lifecycle.   Working in close collaboration with cross-functional partners and engaging effectively with external thought leaders, the role...