Medical Evaluator Jobs (NOW HIRING)

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 use of authorized medicinal products within or outside the terms of the market authorization. The role interfaces with internal stakeholders, contributes to regulatory reports / submissions / queries Key Responsibilities Medical Evaluation and Quality Management: Ensures timely and quality assessment of medical report cases, and answers to queries from Health Authorities according to consistent quality standards. Regulatory Agency Requests: Responsible for timely and concise responses to Regulatory Agency requests relating to medical evaluation of cases. Inspections: Ensures regulatory agency inspection findings and internal audit findings relating to the medical assessment processes are addressed and resultant Corrective Action Plans (CAPA plans) are implemented efficiently and effectively in the function Skills and Experience Required 2 years pharmaceutical / CRO industry experience preferred 2 years of clinical practice experience preferred Qualifications and Education Required Advance Science Degree (MD - RN preferred) Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site (https://www.cslbenefits.com/csl/candidates) to see what's available to you as a CSL employee. About CSL Behring CSL Behring (http://cslbehring.com/) is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma (http://www.cslplasma.com) . Our parent company, CSL (https://www.csl.com/) , headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL (https://www.csl.com/careers/inclusion-and-belonging) . R-263751 CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. https://www.cslbehring.com/careers/eeo-statement #J-18808-Ljbffr