CSL Behring

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. Your role The incumbent will be responsible for the quality and delivery of clinical studies and clinical and regualtory documents across the portfolio in collaboration with strategic CRO partners. Responsible for overseeing the recruiting, staffing and development of the clinical scientists and medical writing specialists in the group.  Your responsibilities will include Oversight of Individuals Recruiting, staffing, training and development of clinical scientists and medical writing specialists in the group, to maintain a dynamic and cutting-edge level of medical scientific expertise and advanced drug development...

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. Could you be our next Director, Medical Writing Resourcing Group Lead? The job is in our King of Prussia, PA, Waltham MA, Maidenhead UK or Zurich Switzerland office. This is a hybrid position and is onsite three days a week. Position Description Summary: You will be responsible for the provision of medical writing services to support clinical development by way of managing the Medical Writing budget project and functional budget, as well as ensuring the medical writing team is resourced appropriately to meet the demands of the portfolio. You are the key leadership role in the Clinical Development group, supporting...

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...

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...