Lead the Project Management Office for R&D
Main Responsibilities & Accountabilities
••Leads PM office which will elevate the craft of all Project Managers in RD by steadily training the best personal practices, tools and methods to an end-to-end community of PM•Challenges the broader organization to be more project centric through outside in thinking, proposing process/culture/governance changes as part of the PPE group.•Provides direct management oversight of PMO group, China PM team (2), Submission PM (4 FTE + FSP) and dotted line reporting for Japan PM (4 FTE); through this ensures that all projects get consistent specialty support from these groups, and that their practices and resources meet the needs of the R&D portfolio.•Provides and trains R&D Project Managers in fit for purpose Tools, Templates and PM learning function that enable RD& projects to be planned in a consistent manner, that meets the needs of the organization for risk management, budget, critical path / timelines and resourcing issues.
Qualifications & Experience
Requirements
•12+ years in R&D project Management or operations•Expert, first-hand knowledge of PM best practices, tools, templates and training groups on these•Experience working in cross-functional R&D teams•In-depth knowledge in drug research, development and manufacturing processes of pharmaceuticals•An advanced degree in Science, Master of Business Administration (MBA), PMP certification, or equivalent is a plus.•Proven ability to work effectively both independently and in a team setting, and to meet set goals by managing own timelines.•Involvement in cross-functional, multicultural and international teams preferable.•Excellent communication skills (written, verbal, presentation) in English; experience adapting messaging to suit the intended audiences•Excellent Strategic Thinking skills•Significant experience in the application and utilization of portfolio management systems and software••About CSL Behring
CSL Behring 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. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at ***************************
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
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.
To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement.
$79k-116k yearly est. Auto-Apply 1d ago
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Associate Director, Biostatistics
CSL Behring 4.6
CSL Behring job in King of Prussia, PA
The Associate Director (AD), Biostatistics, leads the full scope of statistical contribution to a clinical development program. The AD provides statistical strategies for the clinical trials and regulatory submissions and is accountable for the statistical deliverables within the program. ( Positions available supporting multiple Therapeutic Areas available )
Main Responsibilities:
Lead full scope of Biostatistics conduct for the responsible program within a therapeutic area. Define statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions
Influence and contribute to clinical development plans, collaborate with cross-functional team for governance reviews.
Lead statistical strategy for planning and study execution (member of Study Executive Team, Clinical Development Team) and quantitative evaluation to clinical trials, regulatory submissions, and related documents.
Provide statistical thought partnership for innovative study design and clinical development plans, including Go-No Go criteria and probability of technical success calculations.
Provide for project-wide planning of analyses; quality and timely delivery of interim and final results, including integrated analyses for submissions.
Represent Biostatistics in interactions with regulatory authorities (eg, FDA, EMA, PMDA)
Be responsible for interpreting analysis results and ensuring reporting accuracy in study reports and regulatory documents.
Manage outsourcing operations or work with internal statistical programmers within the responsible program. Ensure timeliness and quality of deliverables by CRO/FSP.
Support or lead improvement initiatives within the department, organization and/or pharma industry.
Prepare abstracts, posters, oral presentations and written reports to effectively communicate results of clinical programs and studies to internal and external stakeholders and colleagues with varying levels of clinical research knowledge.
Education and Experience:
PhD with 8 years of experience or MS with 11 years of experience in drug development
Experience providing statistical leadership at compound/indication level
Demonstrated statistical expertise and leadership in facilitating and optimizing the (pre/early/full-) clinical development strategy
Solid experience in applications of advanced statistical methodologies
Leading roles in regulatory submissions
Experience in interactions with major regulatory authorities preferred
Experience with CROs (either managing a CRO, or having worked in a CRO) or managing internal deliveries preferred
Track record of innovation preferred
Competencies:
Familiarity with regulatory guidance and interactions -Broad knowledge of clinical development and processes
Ability to collaboratively work and provide leadership in matrix environment -Strong interpersonal and communication skills (verbal and written in English)
Good working knowledge of SAS and/or R
Expertise in a range of statistical methodologies
Demonstrated use of innovative / creative methodology for analysis of clinical data
Familiarity with relevant regulatory guidance documents
Expertise in:
CDISC, statistical programming, and/or data standards
Biostatistics and Statistical Programming Operations
About CSL Behring
CSL Behring 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. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at ***************************
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
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.
To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement.
$115k-166k yearly est. Auto-Apply 4d ago
Director, Epidemiology
CSL Behring 4.6
CSL Behring job in King of Prussia, PA
CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.
With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions.
Could you be our next Director, Epidemiology? This position is located in our King of PrussiaPA or Waltham MA office. It is a Hybrid role three days onsite.
Responsibilities:
• As the epidemiology lead for designated products proactively define epidemiology research strategies to contribute to R&D and Commercial objectives.
• Plan, coordinate and execute all aspects of epidemiology research programs/studies, including protocol development, data collection, data management, data analysis, report generation, vendor management. Prepare results for internal decision making, regulatory agency submissions, publications and technical reports.
• Contribute epidemiological data in routine and ad hoc regulatory submissions documents (e.g., protocols, Product Clinical Development Plans, Risk Management Plans, Risk Evaluation and Mitigation Strategies, Periodic Safety Update Reports, Development Safety Update Reports, responses to Health Authority questions and requests).
• Lead structured benefit-risk assessments, using qualitative and quantitative methods.
• Contribute strategic and technical expertise in advancing the generation and utilization of RWE across the company.
• Assist the head of department to facilitate ongoing development and growth of the department.
• Actively contribute to CSL organizational efforts and initiatives to develop, communicate, and implement best practices, SOPs, templates, work instructions, etc.
Qualifications:
• Doctoral degree in Epidemiology or related quantitative discipline with at least 10 years of relevant experience (preferably in the pharmaceutical industry); or Master's degree in Epidemiology with at least 12 years of relevant experience in the pharmaceutical industry.
• Demonstrated experience in identifying value of epidemiologic evidence across the lifecycle of assigned products. Ability to proactively advise and lead product teams in this regard.
• Sustained autonomous performance as epidemiology lead to plan for the optimal, fit for purpose application of epidemiological research in product development and post-marketing support for multiple projects with regulatory/methodologic complexity.
• Experience leading cross-functional teams in a matrix organizational structure is required, ideally at a pharmaceutical industry setting.
• Demonstrated experience leading organizational process improvement or change management initiatives.
• Demonstrated knowledge and application of that knowledge of the big picture of the business (i.e., not only the role of Epidemiology) including R&D and Commercial development activities.
#LI-HYBRID
About CSL Behring
CSL Behring 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. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at ***************************
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
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.
To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement.
$56k-110k yearly est. Auto-Apply 3d ago
Senior Director, Head of Global Case Management
CSL Behring 4.6
CSL Behring job in King of Prussia, PA
CSL is transforming its R&D organization to accelerate innovation and create greater impact for patients. With a streamlined, project-led structure and a focus on collaboration, we're building a future-ready team that excels 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 Senior Director, Head of Global Case Management ? The job is in our King of Prussia, PA, Maidenhead UK or Zurich Switzerland office. This is a hybrid position and is onsite three days a week.
You will be a strategic leader that ensures a lean, agile, and cost-efficient organization that delivers the highest standards of patient safety, while maintaining strict compliance with global regulations. The Head of Global Case Management will develop and implement innovative case management strategies across the Enterprise ensuring compliance with regulatory obligations and scientific excellence. The incumbent will spearhead and oversee strategic outsourcing initiatives, organizational redesign, and implement automation to enhance operational efficiency, data quality, and cost savings.
Main responsibilities and accountabilities:
Case Management Responsibilities:
Oversee end-to-end case processing operations, ensuring high-quality, scientifically accurate, timely, and compliant case management across global PV activities.
Monitor regulatory compliance within case processing workflows, ensuring alignment with local and international requirements, including data privacy and governance standards.
Drive continuous improvements in case quality and efficiency through operational benchmarking and implementation of best practices.
Business Transformation:
Lead case processing transformation efforts through strategic outsourcing, automation, and workforce optimization to achieve operational excellence.
Partner with HR to implement workforce change initiatives, including role repurposing, employee retraining, and organizational redesign.
Develop and execute cost-saving strategies, transitioning PV operations from human-led to technology-driven processes
Foster a culture of innovation and continuous improvement to drive long-term organizational agility and adaptability.
Intake & Triage:
Oversee intake and triage processes, including the adoption of automation solutions for initial case processing stages.
Ensure seamless integration of new intake and triage technologies into existing workflows, improving data capture and efficiency.
Establish performance metrics and monitoring systems to evaluate the effectiveness of intake and triage operations.
Vendor Oversight and Management:
Build and maintain strong vendor relationships to ensure high performance, quality, and compliance in outsourced PV operations.
Develop and establish an innovative vendor oversight and management model to drive ICSR excellence
Define and monitor key performance indicators (KPIs) and service-level agreements (SLAs) for vendor performance.
Collaborate with vendors to implement quality improvement initiatives and address compliance challenges.
Oversee vendor audits and risk assessments to ensure alignment with organizational and regulatory standards.
Cross-Functional Collaboration:
Collaborate with internal stakeholders, including quality, and clinical teams, to align the case management function with broader organizational goals.
Manage and oversee budgets for Case Management, ensuring financial targets and project milestones are achieved.
Communicate transformation goals and progress to senior leadership, ensuring alignment with the organization's strategic vision.
Medical Evaluation:
Establishment and maintenance of a high performing outsourced medical evaluation function
Directing the medical evaluation strategy ensuring a consistent, scientifically robust approach embedded in CSL's signal detection framework
Job Qualifications and Experience Requirements
Bachelor's Degree in a relevant scientific or technical field (e.g., MS, PhD, PharmD) preferred.
15+ years in leading multi-year transformation projects, including outsourcing and organizational redesign within PV operations.
Profound experience in vendor oversight and management applying innovative approaches to achieve case management excellence
Demonstrated expertise in implementing PV technology solutions, such as intake automation, safety databases, signal detection, literature screening, and risk management.
Extensive experience in managing global teams and partners
Hands-on experience in vendor management, including negotiating contracts and building large offshore vendor models.
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 to see what's available to you as a CSL employee.
About CSL Behring
CSL Behring 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. Our parent company, CSL, 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.
Do work that matters at CSL Behring!
$68k-103k yearly est. Auto-Apply 3d ago
Principal Biostatistician
CSL Behring 4.6
CSL Behring job in King of Prussia, 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.
Could you be our next Principal Biostatistician? The job is in our King of Prussia, PA, Waltham MA and Maidenhead UK office. This is a hybrid position and is onsite three days a week. You will report to the Director of Biostats.
You will lead components of statistical contribution to a clinical development program. The Principal Biostatistician implements the statistical strategies for the clinical trials and regulatory submissions within the program, and is accountable for the statistical deliverables
Main Responsibilities:
Input to statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions.
Lead components and fully support Biostatistics conduct in study design, protocol development, data collection, data analysis, reporting, and submission preparation.
Author the initial statistical analysis plan for clinical trials and regulatory submissions. Be accountable for timely completion and quality of the statistical analysis plan.
Support Biostatistics interactions with regulatory authorities (eg FDA, EMA, PMDA)
Be responsible for interpreting analysis results and ensuring reporting accuracy.
Manage outsourcing operations or work with internal statistical programmers within the responsible projects. Ensure timeliness and quality of deliverables by CRO/FSP. Conduct reviews of deliverables to ensure quality.
Be accountable for the TFL/CDISC package for study report and regulatory submission.
Provide statistical thought partnership for innovative study design and clinical development plans, including Go-No Go criteria and probability of technical success calculations
Qualifications and Experience Requirements:
PhD or MS in Biostatistics, Statistics
7+ years or relevant work experience
Experience with CROs (either managing a CRO, or having worked in a CRO)
Experience providing statistical leadership at a study level
Demonstrated statistical contribution in facilitating and optimizing clinical development
#LI-HYBRID
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 to see what's available to you as a CSL employee.
About CSL Behring
CSL Behring 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. Our parent company, CSL, 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.
Do work that matters at CSL Behring!
$83k-118k yearly est. Auto-Apply 3d ago
Senior Manager US Advertising & Promotion Lead
CSL Behring 4.6
CSL Behring job in King of Prussia, PA
CSL is transforming its R&D organization to accelerate innovation and create greater impact for patients. With a streamlined, project-led structure and a focus on collaboration, we're building a future-ready team that excels 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 Senior Manager US Advertising and Promotion Lead? The job is in our King of Prussia, PA, Waltham MA, Zurich Switzerland or Maidenhead UK office. This is a hybrid position and is onsite three days a week. You will report to the Head, Global Advertising & Promotional
Position Purpose
Provide an overview of the responsibilities of the position by summarizing the most important aspects and duties.
Ensure compliance with HA drug promotion and promotional labeling regulations for assigned licensed products.
Review, approve, or reject promotional programming based on U.S. Code of Federal Regulations and FDA implementing regulations and guidance.
Adhere to related SOPs and work instructions for established MCC/PRC processes.
Main Responsibilities and Accountabilities
Review advertising and promotional labeling; comment, improve, approve, or reject material based on company practice, CSL policy, U.S. law, and FDA regulations.
Collaborate with Commercial Operations Marketing, Legal, and Medical personnel to minimize HA enforcement risk while supporting CSL's commercial success.
Monitor and apply trends in advertising and promotional labeling regulations to CSL U.S. regional review practices and processes.
Provide regulatory leadership and guidance to marketing during development, review, and approval of promotional materials for assigned therapeutic areas.
Prepare and submit advertising and promotional labeling materials to the FDA as required under 21 CFR 314.81(b)(3)(i) or 21 CFR 601.45.
Maintain technical biologics/medical knowledge for assigned therapeutic areas.
Actively contribute to the global CSL regulatory community through designated projects and assignments.
Review and advise product development teams on communication strategies or tactics regarding investigational products.
Experience
Bachelor's Degree Life Science
Minimum 3 years in Regulatory, Medical, or Legal Affairs or other relevant experience.
Skilled in implementing regulatory science and monitoring enforcement trends.
Ability to read and comprehend product-related technical and medical information.
#LI-HYBRID
About CSL Behring
CSL Behring 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. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at ***************************
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
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.
To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement.
$91k-138k yearly est. Auto-Apply 3d ago
Senior Director, Cardio & Renal Statistics Lead
CSL Behring 4.6
CSL Behring job in King of Prussia, 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 Senior Director, Biostatistics leads the biostatistics function for Cadio and Renal Therapeutic Areas and provides strategic oversight for statistical contributions to clinical development.
This role is responsible for statistical excellence in clinical development plans, trial planning, data analysis, interpretation and reporting, and regulatory interactions and submissions, while partnering closely with Clinical Development and other key stakeholders.
The Senior Director manages a team of statisticians both internal FTEs and external FSPs, and contributes to innovation, operational quality, and cross-functional collaboration.
Key Responsibilities
Lead the Biostatistics function for the assigned Cardio and Renal Therapeutic Area (TA), with accountability for statistical deliverables across all stages of clinical development.
Provide statistical thought leadership to Clinical Development teams in the design of clinical development plans, and clinical trials, ensuring robust methodology and alignment with program objectives.
Partner with Therapeutic Area (TA) leadership, Regulatory, Safety, and other functions to integrate statistical strategy into clinical development plans (CDPs), target product profiles (TPPs), and regulatory submissions.
Ensure high-quality statistical input into study protocols, analysis plans, clinical study reports, and regulatory documentation.
Represent Biostatistics in interactions with regulatory authorities (e.g., FDA, EMA, PMDA) and contribute to preparation of statistical content in submission dossiers.
Champions the use of advanced and innovative design approaches, including simulations and quantitative decision-making frameworks (e.g., Go/No-Go criteria, assurance).
Collaborate with other functions (e.g., Epidemiology, Safety) on initiatives such as real-world evidence and patient safety analysis.
Manage, develop, and mentor statisticians within the therapeutic area to build technical capabilities and ensure delivery excellence.
Build relationships and oversee external vendors and CROs to ensure quality and compliance with timelines and standards.
Contribute to departmental strategy, process improvement, and the advancement of statistical methodology and operations.
Qualifications and Experience
PhD in statistics or related field
10+ years of experience in clinical development within the pharmaceutical or biotechnology industry
Demonstrated leadership in statistical contributions to clinical programs and regulatory submissions
Experience partnering with cross-functional teams and interacting with health authorities
People management experience required; mentorship and team-building strongly preferred
Experience managing external partners (CROs, consultants)
Exposure to or leadership of statistical innovation initiatives preferred
Competencies
Strong statistical methodology knowledge and clinical trial design expertise
Ability to collaborate and influence across functions and levels
Excellent communication and interpersonal skills
Experience with CDISC standards, programming oversight, and statistical operations
Strategic and analytical mindset with a focus on execution
Ability to work in a matrixed environment and lead through influence
About CSL Behring
CSL Behring 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. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at ***************************
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
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.
To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement.
$122k-180k yearly est. Auto-Apply 3d ago
Experienced Phlebotomist
Biolife Plasma Services 4.0
Deptford, NJ job
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers.
Phlebotomist
About the role:
Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a plasma donor screener and perform phlebotomy to support plasma center operations.
How you will contribute:
· You will greet donors as they enter and exit the donor floor.
· You will perform venipuncture of donors and programming of plasmapheresis machine.
· You will monitor donors during the donation process and manage donor reactions.
· You will perform all tasks required for the setup, verification, operation, and troubleshooting of plasmapheresis equipment within scope of training.
· You will install, prime, and disconnect disposable sets on the plasmapheresis machines
· You will stock supplies, break down empty cartons and assist with proper disposal.
· You will take and record donor pulse, blood pressure, and temperature measures and monitor electronic donor questionnaire system.
· You will perform finger sticks, test sample, and record other donor measures to include hematocrit, total protein, and weight.
· You will enter donor information into the Donor Information System (DIS).
· You will coordinate donors to donor floor and compensate donors using the Debit Card system.
· You will support the center management team in identifying operational opportunities for continuous improvement, initiating changes to center processes through use of company approved procedures including 5S, Value Stream Mapping and Kaizen.
What you bring to Takeda:
· High school diploma or equivalent
· Ability to walk and/or stand for the entire work shift
· Will work evenings, weekends, and holidays
· Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees
· Ability to lift to 5 lbs., and occasional lifting of materials up to 32 lbs. and rarely 50 lbs.
· Fine motor coordination, depth perception, and ability to hear equipment from a distance
· Because of potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear
· 1 or more years minimum experience working in a customer or patient facing role is helpful
What Takeda can offer you:
Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program to include retirement benefits, medical/dental, family leave, disability insurance and more, all in a fast-paced, friendly environment.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.
BioLife Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - NJ - Deptford
U.S. Starting Hourly Wage:
$20.50
The starting hourly wage reflects the actual starting rate for this position. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsUSA - NJ - DeptfordWorker TypeEmployeeWorker Sub-TypeRegularTime TypePart time
Job Exempt
No
$20.5 hourly Auto-Apply 1d ago
Capital Equipment Sales - Immunohematology Sales Specialist, (Account Executive) - New York Region
Grifols Shared Services North America, Inc. 4.2
Cherry Hill, NJ job
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
Grifols Diagnostic Solutions is seeking an Immunohematology Sales Specialist (Account Executive) to oversee the territory of **New York, NY** . The Immunohematology Sales Specialist plans, develops, and manage long-term relationships with target customer management teams as well as commercial initiatives to achieve or exceed sales targets. This includes development of strategies and plans that identify opportunities in a direct selling market. This position works in designated sales territory calling on hospitals to achieve annual sales targets and ensuring customer satisfaction through selling immunohematology instruments and reagents.
We are seeking individuals with a Bachelor's degree and 5 or more years of documented success selling laboratory capital equipment within acute care hospital setting and IDNs as evidenced by stack rankings, awards, and commendations.
**Primary responsibilities for role:**
+ Build strategic customer relationships to foster a long-term relationship that favors company's product offerings across local, regional, and nation levels within the IDN/HealthSystem.
+ Identify account priorities from local Hospital and regional IDN interactions that translate into business strategies. Work with the field teams to develop appropriate strategy to meet customer priorities, including a long-term vision for the partnership with the account.
+ Demonstrate a broad comprehension of the customer's needs, market trends, industry challenges, major players, relevant products and technologies.
+ Bring the breadth of the portfolio, services, solutions, and expertise to account.
+ Secure and coordinate necessary resources to communicate, deliver, and reinforce value proposition to the customer.
+ Develop a detailed account plan/forecast and an operating calendar that serves as the basis for weekly activities for self, and the broader account team.
+ Maximize, drive and achieve revenue / profit goals and account profitability for assigned sales territory.
+ Identify new opportunities that will lead to future sales of strategic and operational importance to the customer.
+ Ensure effective use of Budget Allocation and Strategic Planning
+ Ensure effective use and monitoring of all travel and expenses
+ Monitor AR Aging report and ensure customers provide timely payments of invoices.
+ Generate Sales Reports including targeted accounts and activities to achieve sales and operating income targets
+ Ensure Contract Compliance
+ Ensure customers maintain their Inventory at contractually obligated levels
+ Generate accurate monthly sales and accrual forecasts
+ Achieve 100% to plan of annual sales and operating income objectives within the product portfolio
+ Responsible for sales pipeline and forecast to close accuracy
**Knowledge, Skills, and Abilities**
+ Prior knowledge of accounts in and around defined territory.
+ Must have a hunter mentality and experience working in a commission-oriented environment.
+ Strong written and oral communication skills.
+ Ability to work well within a team as well as independently.
+ Ability to manage sales pipeline and budgets.
+ Laboratory/diagnostics experience preferred.
**Education**
Bachelor's Degree required
**Experience**
5 or more years of documented success selling capital equipment within acute care hospital settings and IDNs as evidenced by stack rankings, awards, and commendations.
**Equivalency**
Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience.
**Pay Scale**
The estimated pay scale for Immunohematology Sales Specialist role based in New York, NY, is $113,711 to $135,000 per year. Additionally, the position is eligible to participate in the company's sales incentive plan currently with a $45,000.00 uncapped commission target. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!
\#LI-DC1
Third Party Agency and Recruiter Notice:
Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
**Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law.** **We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.**
Learn more about Grifols (**************************************
**Req ID:** 535466
**Type:** Regular Full-Time
**Job Category:** SALES
**Marketing Intern - Direct‑to‑Consumer Marketing (10‑Week Summer Internship)** Marketing Summer Internship (10 Weeks) CSL Behring | Early Careers Program CSL Behring is a global biotherapeutics leader driven by our promise to save lives. We discover, develop, and deliver innovative therapies for patients living with conditions across immunology, hematology, cardiovascular and metabolic disease, respiratory disease, and transplant medicine. Our innovation is powered by three core scientific platforms: plasma fractionation, recombinant protein technology, and cell and gene therapy-helping address unmet medical needs and improve patients' lives worldwide.
**Internship Overview**
Are you looking for a 10‑week summer internship designed to kick‑start your career in healthcare marketing?
As a Marketing Intern supporting the Direct‑to‑Consumer (DTC) Marketing team, you will gain hands‑on experience helping shape the future of consumer engagement in rare disease. This internship offers exposure to social listening, consumer insights, and omnichannel marketing strategy, providing a unique opportunity to apply modern marketing techniques within a highly regulated healthcare environment.
You will work closely with marketing leadership and cross‑functional partners to analyze consumer behaviors, identify engagement opportunities, and translate insights into actionable marketing recommendations.
**What You'll Gain**
- Ownership of a high‑impact consumer insights project
- Exposure to modern DTC marketing, social listening, and omnichannel strategy
- Experience translating qualitative insights into strategic recommendations
- Collaboration with senior marketing leaders and cross‑functional teams
- Mentorship and professional development throughout the internship
By the end of the program, you will leave with practical experience, a portfolio‑worthy project, and a deeper understanding of how consumer insights shape marketing strategy in the biopharmaceutical industry.
**Key Responsibilities**
Under the guidance of Marketing Leadership, you will:
- Conduct social listening across patient forums, advocacy groups, and social platforms to identify themes related to trust, education, and engagement
- Analyze conversations for sentiment and key insights, including education gaps, emotional support needs, and treatment barriers
- Research consumer expectations and trusted brands outside of pharma to understand loyalty drivers, personalization, and authenticity
- Compare social listening findings with broader consumer marketing trends
- Support the development of actionable insights to inform CSL Behring's omnichannel and influencer strategies
- Synthesize findings into a final insights report and strategic recommendations
- Present outcomes and recommendations to senior marketing leadership
**Qualifications**
_Education_
- Rising junior or senior pursuing a bachelor's degree in Marketing, Business, Communications, or a related field
_Skills & Experience_
- Strong analytical, research, and critical‑thinking skills
- Interest in healthcare marketing, consumer behavior, and digital innovation
- Excellent written, verbal, and presentation skills
- Curious, creative, and eager to learn in a collaborative environment
**About CSL Behring**
CSL Behring 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. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at ************************** .
**Our Benefits**
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL (********************careers/your-well-being) .
**You Belong at CSL**
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.
To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging
**Equal Opportunity Employer**
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement .
R-267328
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. ************************************************
$20k-30k yearly est. 24d ago
Director, Global Clinical Program Leader, Immunoglobulins
CSL Behring 4.6
CSL Behring job in King of Prussia, 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.
Could you be our next Director of Clinical Program, Immunoglobulins ? 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.
You will be a critical role within Clinical Development. You are accountable for the design and execution of the clinical strategy to support the development of a medicine, aligned with the Project Strategy Document (PSD) and the Target Product Profile (TPP). The GCPL is accountable for the strategic leadership of the Clinical Development Team (CDT) in a matrix environment and is responsible for:
+ the timely development and execution of the Clinical Development Plan (CDP).
+ managing the day-to-day operations of the CDT including but not limited to meeting coordination and documentation, decision making, and stakeholder management.
+ ensuring that the program is conducted in alignment with CSL Behring processes and abiding by GCP and ICH regulations.
This position is accountable for the clinical & scientific oversight of the assigned program(s) and:
+ ensures high quality clinical & scientific standards are met during all aspects of the program
+ providing clinical oversight and expertise during development of clinical studies
+ serves as medical monitor for assigned clinical trials or provides oversight to an assigned medical monitor
+ serves as the Clinical Development representative on the required cross-functional Delivery Teams (DT)
This position is a "Lead Author" or "Contributing Author" for:
+ key study documents, including but not limited to the Clinical Development Plan (CDP), the Project Strategy Document (PSD), Investigator Brochures (IB), Clinical Study Protocols (CSP), Informed Consent Forms (ICF), Medical Monitoring Plans (MMP), Clinical Study Reports (CSR).
+ the clinical sections of relevant regulatory packages (e.g. IND, NDA, annual reports) and support regulatory RFIs as needed.
+ the development of abstracts, presentations, and manuscripts as appropriate.
**Main Responsibilities**
1 Clinical Development Team (CDT) Leadership:
+ Provides leadership and guidance to all members of the cross-functional CDT acting as the lead scientific expert for the clinical program, while ensuring appropriate functional representation in team discussions.
+ Is accountable for the timely development and maintenance of the Clinical Development Plan (CDP) in alignment with the Program Strategy Team (PST) and Therapeutic Area Leadership Team (TALT).
+ Leads the integration of internal and external expert contributions to strategy and design of the assigned clinical program(s).
+ Responsible for maintaining alignment across critical stakeholders prior to key decision making forums (e.g. Strategic and Technical Review Committee (STRC) for study outline approval.
+ Ensures that the program is conducted in alignment with CSL Behring processes and abiding by GCP and ICH regulations.
+ Responsible for driving and documenting decision making within the CDT, facilitating issue resolution and escalation, as well as contingency planning.
2 Clinical & Scientific Oversight:
+ Accountable for the clinical content for all CDT deliverables to ensure safe, efficient, and timely execution of assigned clinical programs.
+ Ensures high quality clinical and scientific standards are met throughout all aspects of the program.
+ Serves as the clinical development representative on the required cross-functional Delivery Teams (DT) including but not limited to the Safety Management Team (SMT), the Benefit-Risk Assessment Team (BRAT), the Biomarker Expert Team (BET), and the Evidence and Access Strategy Team (EAST) for assigned programs.
+ Develops and executes the Medical Monitoring Plan (MMP) strategy. Typically serves as the medical monitor for clinical trials during study conduct or provides oversight to assigned medical monitors.
+ Presents results to Safety Monitoring Committee and other internal and external meetings.
3 Document Authorship:
+ Reviews the data generated during the planning and execution of a study to gather a clinical understanding of the safety and efficacy results and the impact of the data on ongoing R&D strategies and provides support in defining the development strategy.
+ "Lead Author" or "Contributing" Author for key study documents, including but not limited to: the TPP, PSD, CDP, Study Concept Scenarios, Study Outlines, the Investigator Brochure (IB), Clinical Study Protocols (CSP), Master Informed Consent Forms (ICF), Medical Monitoring Plans (MMP), Safety Review Committee (SRC)/Independent Data Monitoring Committee (IDMC) Charters, and Clinical Study Reports (CSR).
+ Leads preparations of clinical sections of relevant regulatory interaction packages including but not limited to briefing books, INDs, NDAs. BLAs, ODDs, RFIs, and routine reporting.
+ Contributing author the publication strategy. Author or contributing author for abstracts, presentations, and manuscripts as appropriate.
**Qualifications and Experience Requirements:**
+ Advanced degree (MD or PhD) in life science/healthcare expected
+ MD - Board Certified (or non-USA equivalent) in relevant field is preferred.
+ - Clinical development industry experience with a working knowledge of pharmaceutical and regulatory development processes is essential.
+ - 3+ years of relevant clinical development experience is expected including experience of study data review/evaluation in a pharmaceutical or clinical study environment.
+ - Demonstrated program leadership capabilities in a matrix environment
+ - Demonstrated stakeholder management skills including risk mitigation
+ - Proficient in project management terminology and processes to drive clinical development program risk mitigation strategies
\#LI-HYBRID
**About CSL Behring**
CSL Behring 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. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at ************************** .
**Our Benefits**
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL (********************careers/your-well-being) .
**You Belong at CSL**
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.
To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging
**Equal Opportunity Employer**
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement .
R-263497
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. ************************************************
$73k-127k yearly est. 60d+ ago
Executive Director, Enterprise Infrastructure & Digital Core
CSL Behring 4.6
CSL Behring job in King of Prussia, PA
Title (Business Title):** Executive Director, Enterprise Infrastructure & Digital Core **Business/Functional Unit:** I&T The Executive Director, Enterprise Infrastructure & Digital Core is responsible for all aspects of the digital core. At CSL, the digital core is the technology foundation that supports all aspects of CSL's business including cloud computing, networking, voice, and hosting.
This role plays a pivotal role in driving the modernization and innovation of CSL infrastructure ecosystem to provide flexible, scalable platforms that can streamline data flows and integrate seamlessly with cloud services and other technologies. Working closely with the technology office, they will set priorities and standards, drive development and implementation, and manage strategic partners to ensure the digital core meet CSL requirements as it relates to robustness, security, reliability, scalability, consistency, and cost effectiveness.
The leader will manage a team of IT professionals and collaborate with cross-functional teams, such as cybersecurity, identity governance and enterprise systems. They must stay abreast of emerging technologies and industry trends to identify opportunities for digital growth and improvement, fostering a culture of continuous innovation and efficiency. They must demonstrate effective communication and strategic planning skills as this leader must be able to articulate the digital vision to stakeholders and drive initiatives that enhance performance and customer experience over time.
**Reporting Relationships:**
Reports to: SVP, Infrastructure, Cybersecurity, & End User Services & CISO
Direct reports: Team of 4-6 senior level independent contributors and senior leaders.
**Main Responsibilities and Accountabilities:**
**Strategic Leadership and Technical Acumen**
+ Develop, execute, and continuously evolves a comprehensive digital core strategy that aligns with the CSL's mission and objectives. Set the mission, vision, and strategy of the Digital Core Delivery area to maximize the success of business and technology initiatives and transform the company's infrastructure to a modern, scalable, and efficient environment.
+ Lead and inspire a large team of technical professionals, foster a culture of innovation, collaboration, and excellence. Conceptualize and oversee the development of curriculums to upskill the team as needed as the company transforms its digital core aimed at developing full stack intelligence technical professionals.
+ Set priorities and provide effective budget management ($100M) for the Digital Core Delivery area.
+ Stay abreast of and introduce innovative, differentiating capabilities that enhance CSL digital agenda and competitive capabilities.
+ Foster and maintains strategic, relationships with external vendors, service providers, and other key providers.
+ Maintain industry relationships; may be required to speak at or support industry or strategic partner lead conferences.
+ Coach team to set and achieve individual development goals that support the strategy, providing meaningful developmental experiences to include formal training opportunities and stretch assignments.
**Cloud, Hosting and Network Management**
+ Oversee the deployment, management, and optimization of cloud and hosting solutions to ensure scalability, reliability, and security. Ensure seamless integration of cloud services with on-premises systems and applications.
+ Drive the adoption of cloud-native, future-ready technologies and best practices to support application migration, CSL's data fabric and analytics.
+ Drive automation across the digital core aimed at efficiency and reduction of incidents and related outages.
+ Manage and optimize the company's network environment to support high availability, monitoring and observability, and performance, and security.
+ Ensure robust network monitoring, observability, and automation across the digital core.
**Local and Regional Delivery and Operations, Manufacturing and Plasma Center support**
+ Oversee technology delivery and support for local corporate offices, manufacturing sites, plasma centers and affiliates.
+ Ensure consistent and efficient IT service delivery across all locations.
+ Implement standard operating procedures and best practices for IT support and operations.
+ Work closely with the manufacturing automation and plasma center support team to ensure the digital core meet the unique needs of these business areas.
**Modernization and Technical Debt Reduction**
+ Identify and drive reduction of areas of technical debt within the company's infrastructure and legacy data centers.
+ Lead initiatives and projects to modernize legacy infrastructure components and related systems. to improve efficiency, reduce costs, and enhance agility.
**Service Provider Management**
+ Oversight of Managed Service Providers to ensure service level management (SLA) and Experience Level management (XLA) metrics are consistently met.
**Position Qualifications and Experience Requirements:**
Education
+ Undergraduate degree in Information Technology, Computer Science, or a related field preferred. Related certifications, and advanced graduate studies desirable.
Experience
+ 15+ years' experience in the pharmaceutical/biotechnology industry. Experience in regulated manufacturing environments would also be a good candidate.
+ Strong interpersonal skills to quickly build rapport and credibility with CSL leaders and key external stakeholders.
+ Track record of leading infrastructure transformation and modernization initiatives.
+ Strong understanding of cloud technologies, network management, and IT operations.
+ 7-10 years' experience leading and managing teams in a 24x7 international environment and with cross-functional teams.
+ Strong Project management, technical change management, and use of agile methodologies experience.
+ Knowledge of cybersecurity best practices and compliance requirements.
Competencies
+ Excellent writing and oral communication skills; critical thinking and innovation; ability to convey risk to cause appropriate action.
+ Thinks beyond and incorporates external factors into business strategy.
+ Builds bridges and empowers One-CSL teams.
+ Unleashes outcomes and creates an environment of decision making and appropriate risk taking
+ Ignites agility and creates a nimble environment.
+ Inspires the future and drives the strategy throughout the organization.
+ Cultivates talent and takes proactive steps to secure future talent
Minimum requirements and flexible working hours will be considered as related to our EEO policy.
**About CSL Behring**
CSL Behring 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. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at ************************** .
**Our Benefits**
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL (********************careers/your-well-being) .
**You Belong at CSL**
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.
To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging
**Equal Opportunity Employer**
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement .
R-245870
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. ************************************************
$77k-133k yearly est. 60d+ ago
Donor Center Technician I
Octapharma Plasma 3.8
Pennsauken, NJ job
Want to Expand your career-development potential, your ability to help donors and patients, and your access to professional opportunities? We're growing fast. [You can, too!] There are so many ways Octapharma Plasma can enhance your life and your career. Our strong growth is creating great learning and career development opportunities throughout our company, and especially our donation centers. Because you're someone who loves to learn, enjoys people, and has a real heart to help, we encourage you to join us as a:
Donor Center Technician
This is What You'll Do:
* Ensures total operation is compliant with state and federal regulations (e.g. FDA approved
Standard Operating Procedures, OSHA, CLIA, and GMP) to maintain the highest production
standards and ensure facility compliance.
* Maintains high level of customer service and positive donor experience in line with company
values and culture.
* Maintains cleanliness of work area to ensure a clean and professional environment. Stocks and
maintains an orderly work area with sufficient supplies to meet production demands.
* Maintains Donor Center equipment based on Standard Operating Procedures and applicable
manufacturer instructions.
* Monitors donor conditions, employing techniques to ensure donor comfort, safety, and the quality
of plasma product.
* Maintains Donor confidentiality based on company policy.
* Maintains complete and accurate record keeping per company's Standard Operating Procedures.
* Responsible for troubleshooting machine alarms/alerts and perform QCs routinely (defined as
daily/monthly) on equipment.
* Cleans any blood or plasma spills and performs proper procedure for disposition of biohazardous
waste.
* Performs other job-related tasks, as assigned.
Donor Eligibility:
* Ensures that donor meets eligibility criteria based on Standard Operating Procedures.
* Performs donor vitals evaluation per Standard Operations Procedure.
* Performs finger stick for Microhematocrit and Total Protein determination.
* Registers applicant donors per Standard Operating Procedures.
Plasma Collection:
* Sets up and prepares all equipment and disposable supplies for venipuncture and
plasmapheresis procedures per standard operating procedures.
* Disconnects donor after plasmapheresis process is completed per standard operating
procedures.
* Maintains proper ratio to ensure donor safety and quality of product.
* Operates the automated plasmapheresis machines including response and evaluation of all
machine alarms and alerts, responds to donor adverse events, and documents exceptions.
Product Processing:
* Prompt and sterile collection and storage of plasma product and samples per Standard Operating
Procedures.
* Handles tested and untested product, as well as product with unsuitable test results.
* Properly organize samples and product in a walk-in storage freezer per Standard Operating
Procedures.
* Prepares product and samples for shipments, per Standard Operating Procedures and federal
transportation regulations.
* Monitors freezer and refrigerator temperatures and immediately inform appropriate personnel if
equipment is not functioning properly. Record variance if applicable.
JOB SPECIFICATIONS:
* High school diploma or equivalent (GED) required.
* Three (3) months' experience in clerical or customer service position preferred.
* Specific certification or licensing based on State requirements.
* Basic computer knowledge and skills required.
* Ability to speak, read, write (legibly and accurately), and understand English required.
* Strong customer service skills required.
* Strong organizational skills required.
* Ability to read, follow, and interpret regulations, instructions and manuals required.
* Ability to understand verbal instruction required.
* Ability to read numbers on screening equipment and perform basic mathematical calculations
required.
* Effective communication skills required.
SCHEDULING:
* Must be able to workday and evening hours, weekends, holidays, and extended shifts on a
frequent basis.
* Attendance and punctuality required.
PHYSICAL REQUIREMENTS:
* Utilize all required and appropriate PPE (Personal Protective Equipment) at all times.
* Ability to sit or stand for extended periods.
* Ability to tug, lift, and pull up to thirty-five pounds.
* Ability to bend, stoop, or kneel.
* Occupational exposure to blood borne pathogens.
* Ability to view video display terminal less than 18" away from face for extended periods of
time, up to four (4) hours at a time.
* Ability to work in an environment with a temperature of -40C or colder for extended periods.
Occasional exposure to and handling of dry ice.
* Ability to perform precise tasks that require repetitive small motor skills, such as drawing
blood for diagnostic tests.
* Ability to use assistive devices if needed for mobility or communication.
Do Satisfying Work. Earn Real Rewards and Benefits.
We're widely known and respected for our benefits and for leadership that is supportive and hands-on. Managers who truly want you to grow and excel.
* Formal training
* Outstanding plans for medical, dental, and vision insurance
* Health savings account (HSA)
* Flexible spending account (FSA)
* Tuition Reimbursement
* Employee assistance program (EAP)
* Wellness program
* 401k retirement plan
* Paid time off
* Company paid holidays
* Personal time
More About Octapharma Plasma Inc.
With donation centers and team members throughout the U.S., Octapharma Plasma, Inc. collects plasma to create life-saving medicines for patients worldwide. We are growing at an impressive pace, and so is the positive impact of our work. Our community relies on teamwork, compassion, and expertise to get things done the right way, while making a meaningful difference in the lives we touch.
The expected base pay for this position is $15.59 - $20.79 - $25.99. Please note this wage range reflects what Octapharma Plasma expects to pay for this position at the listed location as of the time of this posting. Individual base pay for a successful candidate within this range is determined by qualifications, skill level, experience, competencies and other relevant factors.
Working at Octapharma Plasma
We aspire to create a culture in which our employees feel inspired. You may be motivated to connect with donors, lead donation centers to new heights of excellence, or provide ideas and vision at a corporate level. We welcome you to consider all possibilities and see what positions best fit your interests and talents. Join the Octapharma Plasma team
With donation centers and team members throughout the U.S., Octapharma Plasma is growing at an impressive pace, and so is the positive impact of our work. Forming a diverse, inclusive, and collaborative community, Octapharma Plasma offers ways to enhance your life, career, and sense of professional accomplishment to everyone who joins our family.
Please be advised that, although we may not have an immediate requirement at this time, we are consistently interested in engaging with well-qualified candidates for future opportunities. If you are interested in exploring a career with Octapharma Plasma, please apply. Someone will follow up depending on the current needs, but please be aware correspondence may not be immediate. We expect the application window to close within 60 days from the posting date. Please ensure all applications are submitted before the deadline.
Interested? Learn more online and apply now at:
octapharmaplasma.com
And if you know someone else who'd be a great fit at Octapharma Plasma, Inc., please forward this posting along!
INNER SATISFACTION.
OUTSTANDING IMPACT.
$15.6-20.8 hourly 60d+ ago
Plasma Center Registered Nurse (BSN)
Biolife Plasma Services 4.0
Deptford, NJ job
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice (************************************** and Terms of Use (********************************************* . I further attest that all information I submit in my employment application is true to the best of my knowledge.
**Job Description**
Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers.
About BioLife Plasma Services
Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a Medical Support Specialist (Plasma Center Nurse) to support plasma center operations.
BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd.
**Now offering daily pay to our hourly team members! Don't Wait For Payday. Get Your Pay Today.**
About the role:
Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will determine donor eligibility to donate plasma, management of donor adverse events, review of laboratory test results, and donor notification of unsuitable test results. The Medical Support Specialist (Plasma Center Nurse) works under the guidance of the Center Manager (or Assistant Manager as applicable) for operational guidance and under the management of the Center Physician for medical issues. The Medical Support Specialist will be familiar with regulations of the plasma collection industry or a manufacturing environment. The Medical Support Specialist follows guidance provided by BioLife Medical Affairs and provides center level support of environmental, health and safety (EHS).
How you will contribute
You will determine donor eligibility; to include, proper management of informed consent, AIDS education and confidential self-exclusion, medical history interview and acceptance requirements, physical examination, blood testing, and reviewing Serological Protein Electrophoresis (SPE).
You will evaluate donor reaction(s), which occurs at the facility as outlined in the SOPs. Follow applicable SOPs for medical emergencies including the development of Center Physician's standing orders and donor transport to emergency care facilities.
You will refer to the Center Physician or Medical Affairs (as applicable) when in need of providing unacceptable findings to donors, or guidance concerning medical or technical issues, including donor safety and eligibility.
You will support the Hepatitis B and Seasonal Flu vaccination programs for employees as applicable.
You will manage employee incidents and determine whether further evaluation is required by occupational health/ER. Refer to EHS guidance regarding employee incidents.
You can be a Pandemic Coordinator when authorized by EHS and support investigations associated with pandemic threats within the local community as indicated by EHS or Medical Affairs.
What you bring to Takeda:
High school diploma or equivalent to including graduate equivalent of a recognized educational nursing program with state requirements
Currently licensed or certified in the state where responsibilities will be assigned: Registered Nurse (RN), Nurse Practitioner (NP) or Physician Assistant (PA)
Current Cardiopulmonary Resuscitation (CPR) and AED certification
Fulfill state requirements (in state of licensure) for basic IV therapy
Satisfactorily complete the FDA approved training requirements for BioLife Medical Support Specialist
Two years in a clinical or hospital setting
What Takeda can offer you:
Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program to include medical/dental, paid time off and retirement benefits, all in a fast-paced, friendly environment.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to bring Better Health and a Brighter Future to people around the world.
**BioLife Compensation and Benefits** **Summary**
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
**For Location:**
USA - NJ - Deptford
**U.S. Hourly Wage Range:**
$36.96 - $50.82
The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
**EEO Statement**
_Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._
**Locations**
USA - NJ - Deptford
**Worker Type**
Employee
**Worker Sub-Type**
Regular
**Time Type**
Full time
**Job Exempt**
No
$37-50.8 hourly 60d+ ago
Associate Director, Global Medical Communications
CSL Behring 4.6
CSL Behring job in King of Prussia, PA
**Responsibilities and Accountabilities** **1.** In close collaboration with TA leads, accountable for planning and execution of updated content including some new content including SCP and Lexicon. Provide first line support for manager/senior manager
**2.** Accountable to ensure lexicon is consistent across all medical materials
**3.** Accountable for the process of review/approval of global medical resources including global conference material as aligned in congress planning. Provide first line support for manager and senior manager
**4.** Accountable for the overall budget of the respective TA supported. First line budget support for mgr and sr mgrs
**5.** Accountable for ensuring all planned medical resources are on track and support the annual medical plan for content creation. Provide support to junior team members
**6.** Accountable for all vendor management activities with key support provided with first line support to junior team members
**7.** Represent GMC at strategic meetings for annual planning and other strategic activities for respective TA
**8.** Ensure appropriate tagging in Veeva for all GMC materials in close collaboration with Sr mgr. Accountable for all global materials to be housed in a centralized platform
**Education**
Degree in nursing, pharmacy, or advanced degree in science/medicine (MD. PhD, Pharm D) preferred with 10+ years of pharmaceutical/biotherapeutics industry experience.
Prior experience in global medical communications is strongly preferred. Omnichannel and digital experience is a plus
**Experience**
Experience working in a matrixed global organization
**Competencies**
Strong medical communications skills including demonstrated ability to lead the operational execution of scientific materials.
Demonstrated superior effective vendor management and project management skills
Budget management a plus
Strong scientific knowledge with ability to independently assess content and target materials to appropriate audience
**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 (******************************************* to see what's available to you as a CSL employee.
**About CSL Behring**
CSL Behring (*********************** 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 (************************* . Our parent company, CSL (********************* , 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 (**************************************************** .
**Do work that matters at CSL Behring!**
R-265396
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. ************************************************
$73k-120k yearly est. 55d ago
Director, R&D Architecture Lead
CSL Behring 4.6
CSL Behring job in King of Prussia, PA
Responsible for defining and driving the digital architectural vision and strategy for R&D initiatives. This role will own the creation and maintenance of the R&D Digital Roadmap (City Plan) and the architectural decisions across the R&D Digital projects. This role acts as a bridge between scientific innovation and technical execution, ensuring the creation of scalable, secure, and high-performance systems that enable cutting-edge research and product development.
**Main** **Responsibilities & Accountabilities**
-Lead the design, development, and evolution of R&D systems architecture, including data pipelines, computational platforms, and integration frameworks
-Collaborate with Digital Business Partners, scientists, engineers, and product teams to align architecture with R&D goals and overall business strategy
-Evaluate emerging technologies and propose architectural innovations to enhance R&D productivity and enable next-generation research solutions
-Ensure architectural compliance with security, scalability, and regulatory standards, ensuring systems meet operational and compliance requirements
-Develop and maintain comprehensive architectural documentation, roadmaps, and reference models to guide development efforts
-Mentor technical teams, promoting best practices in software and systems architecture across projects and teams
-Partner with the I&T Enterprise Architecture team to define enterprise standards and ensure alignment of R&D roadmaps with CSL technology direction
**Qualifications & Experience Requirements**
-Bachelor's or Master's degree in Computer Science, Engineering, or a related technical field
-12+ years of experience in software or systems architecture, with at least 3 years in an R&D or innovation-driven environment
-Strong understanding of cloud-native architectures, microservices, and data-intensive systems
-Experience with R&D platforms in biotech, pharma, materials science, or related fields is a plus
-Proficiency in architectural modeling tools and frameworks such as TOGAF, ArchiMate, or similar tools
-Excellent communication and leadership skills, with the ability to engage cross-functional teams and communicate complex architectural concepts clearly
**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 (******************************************* to see what's available to you as a CSL employee.
**About CSL Behring**
CSL Behring (*********************** 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 (************************* . Our parent company, CSL (********************* , 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 (**************************************************** .
**Do work that matters at CSL Behring!**
R-260649
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. ************************************************
$67k-108k yearly est. 60d+ ago
Medical Information Specialist
CSL Behring 4.6
CSL Behring job in King of Prussia, PA
Role: The Medical Information Specialist will be responsible for providing accurate and timely medical information to healthcare professionals, patients, and internal stakeholders, the creation of global scientific response documents, and the medical review of medical and promotional materials.
Responsibilities:
+ Provides medical information on CSL products, responding to inquiries and writing standard responses to frequently asked questions
+ Ensures that clinical information database is accurate and up-to-date
+ Leverage insights from medical inquiries and work with cross-functional partners to help inform medical strategy and medical content
+ Maintains relationships and collaborates with marketing, commercial, research project teams, and global medical operations functions
+ Oversees the medical review of promotional materials ensuring medical/scientific accuracy and adherence to local regulations as applicable
+ Lead/co-lead planning and staffing of Medical Affairs Booth
Qualifications:
+ Degree in nursing, pharmacy or advanced degree in science/medicine (MD, PhD, PharmD) preferred
+ 2-5 years' medical information experience in the pharmaceutical/biopharmaceutical industry
+ Knowledge of biomedical literature review and publication search
+ Knowledge of federal regulations regarding drug promotion and dissemination of medical and product information
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
**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 (******************************************* to see what's available to you as a CSL employee.
**About CSL Behring**
CSL Behring (*********************** 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 (************************* . Our parent company, CSL (********************* , 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 (**************************************************** .
**Do work that matters at CSL Behring!**
R-264198
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. ************************************************
$78k-124k yearly est. 47d ago
LPN
Octapharma Plasma 3.8
Audubon, NJ job
Looking to Strengthen
your positive impact on patients' lives,
your level of excitement at work,
and your compensation?
We thrive on change.
[So can you!]
The role of a Medical Professional at Octapharma Plasma is rewarding in every sense of the word. No two days are the same as every situation brings exciting new challenges-ones we meet with genuine empathy, skill, and enthusiasm. Our rapidly expanding organization offers the ability to enhance lives, exhilarating work, and the compensation you deserve. Join us as a:
Medical Professional
This Is What You'll Do:
Determines donor eligibility of new and return donors for plasmapheresis procedures and immunizations by conducting evaluations to ensure criteria of plasma donors are met and in accordance with SOPs, Food and Drug Administration (FDA), Clinical Laboratory Improvement Act (CLIA), and cGMP.
Reviews informed consent forms for plasmapheresis and immunization. Includes explanation of procedures, potential adverse events, immunization schedules, possible antibody formation, and dose administration. Offering clear opportunity for donor to refuse participation.
Performs medical history reviews and health assessments for donors.
Maintains accurate and up-to-date Physician Communication Logs, in accordance with SOP.
Understands and utilizes donor center's donor management system (NexLynk).
Uses SOPs to facilitate compliance with regulations.
Complies with federal, state, local, and company-specific regulations related to quality of product, employee and donor safety, and the proper performance of day-to-day activities.
Reviews donor management system (NexLynk) and/or immunization paperwork to ensure accuracy and completeness.
Reviews accumulated data in a timely fashion to confirm eligibility and consults with donor center Licensed Physician, as needed.
Classifies donors to appropriate program.
Monitors donor reactions to plasmapheresis and documents accordingly.
Provides appropriate medical care per SOP to donors if complications arise.
Interacts with donor center Licensed Physician regarding ordering immunizations.
Monitors donors for possible adverse reactions to immunization.
Medical Professional may not fulfill Licensed Physician's responsibilities in RBC immunization programs.
Performs duties for the Hyperimmune Program, if applicable, as described in SOPs.
Reviews all normal and abnormal test results in donor management system (Nexlynk) to determine continued donor eligibility.
Ensures confidentiality of employee, donor, and donor center records while performing all duties.
Counsels donors with abnormal test results or eligibility concerns and defers them according to the donor deferral matrix. Refers donors to appropriate county/state health department or similar for follow-up and diagnostic testing, when applicable per SOP.
This Is Who You Are:
Graduate of a recognized healthcare-related educational program, such as Physician, Nurse (Licensed Practical Nurse or Registered Nurse). Certified/licensed as an emergency medical technician (EMT Basic, EMT 2-intermediate, or 3- advanced/paramedic, if allowable).
Ability to work shifts consisting of day and evening hours, weekends, holidays and extended shifts on a frequent basis.
Must work within the scope of the professional license/certification, as defined by the state in which the work is performed.
Any specific state licensing requirements must be met per location.
One (1)-year experience in the hospital, field care, or experience in a plasma center preferred.
Everyone performing moderate complexity testing must possess a current license issued by the state where the donor center is located, based on any required state regulations.
Must successfully complete training program and competency assessments using OPI approved training modules or training curriculum.
Must have excellent patient/donor assessment skills.
Must be able to manage emergency situations in accordance with standard medical care practices.
Maintain current and valid license and pass medical credential evaluation.
Must maintain current cardiopulmonary resuscitation (CPR) certification.
Must be highly organized and have attention to detail.
Possess effective physical and clinical assessment skills customer service and people management skills.
Ability to understand and follow SOPs and protocols.
Must possess basic computer knowledge and skills. Basic working knowledge of Microsoft Word and Excel preferred.
Must be able to speak, read, write, and understand English.
Demonstrate consistency and reliability (good attendance, punctuality, full effort throughout shift, flexibility with assigned schedule).
Ability to work shifts consisting of day and evening hours, weekends, holidays and extended shifts on a frequent basis.
This Is Why LPNs Love Working Here:
Our team is immersed in a setting of constant, exciting change
Excellent teamwork/friendly co-workers
Supportive environment
Strong ethical standards
Opportunities for advancement
Do Satisfying Work. Earn Real Rewards and Benefits.
We're widely known and respected for our benefits and for leadership that is supportive and hands-on. Managers who truly want you to grow and excel.
Formal training
Outstanding plans for medical, dental, and vision insurance
Health savings account (HSA)
Employee assistance program (EAP)
Wellness program
401 (k) retirement plan
Paid time off
Company-paid holidays
Personal time
More About Octapharma Plasma, Inc.
With donation centers and team members throughout the U.S., Octapharma Plasma, Inc. collects plasma to create life-saving medicines for patients worldwide. We are growing at an impressive pace, and so is the positive impact of our work. Our community relies on teamwork, compassion, and expertise to get things done the right way, while making a meaningful difference in the lives we touch.
The expected base pay for this position is $27.28 - $36.37 - $45.47. Please note this wage range reflects what Octapharma Plasma expects to pay for this position at the listed location as of the time of this posting. Individual base pay for a successful candidate within this range is determined by qualifications, skill level, experience, competencies and other relevant factors.
Interested? Learn more online and apply now at:
Join Octapharma: Careers at Octapharma Plasma
And if you know someone else who'd be a great fit at Octapharma Plasma, Inc., please forward this posting along.
INNER SATISFACTION.
OUTSTANDING IMPACT.
$27.3-36.4 hourly 60d+ ago
Manager, Global Reporting & Business Intelligence
CSL Behring 4.6
CSL Behring job in King of Prussia, PA
**The Opportunity:** In this role, you will work closely with the Director to oversee the design, implementation, and management of data analytics and performance reporting systems. You will be responsible for collaborating with multiple departments and providing actionable insights to support decision-making to improve operational and commercial outcomes.
**The Role:**
+ Oversee the creation and maintenance of performance dashboards and reports to track KPIs across commercial functions like Pricing or Sales Operations
+ Collaborate with cross-functional teams to ensure data needs are met and insights are communicated effectively to support decision-making.
+ Ensure data quality, governance, and integration from diverse internal and external sources for unified reporting.
+ Lead BI projects, managing timelines, deliverables, and alignment with business objectives.
+ Implement predictive analytics and advanced reporting techniques to provide actionable insights for business strategies.
+ Provide mentorship and guidance to BI team members, promoting continuous improvement and innovation in reporting practices.
+ Ensure compliance with regulatory requirements in all data management and reporting activities.
**Your skills and experience:**
+ Bachelor's or master's degree in computer science, Information Management, Math, Statistics, or a related field
+ 3-5 years of experience in relevant analytics roles and prior BI/reporting team lead experience preferred
+ Experience with pharmaceutical industry data sources (e.g., IQVIA DDD / Midas, Claims, LRx / Dx) is required
+ Strong analytical as well as BI tools (Tableau, Power BI, Qlik etc.) experience preferred. Experience with regulatory compliance related to data privacy and protection.
+ Exceptional communication and interpersonal skills, with the ability to actively engage and influence partners at all levels.
+ Excellent leadership and team management skills, with the ability to inspire and develop impactful teams
**About CSL Behring**
CSL Behring 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. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at ************************** .
**Our Benefits**
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL (********************careers/your-well-being) .
**You Belong at CSL**
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.
To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging
**Equal Opportunity Employer**
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement .
R-267711
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. ************************************************
$82k-107k yearly est. 4d ago
Executive Director, Head of Clinical Science and Medical Writing
CSL Behring 4.6
CSL Behring job in King of Prussia, 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.
**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 approaches
Ensuring delivery of high-quality clinical development content including:
+ Clinical development plans, protocols, study reports, common technical document modules and publications in academic journals
+ Regulatory submissions and meetings
+ Stage-gate and benefit -risk evaluations and assessments
+ Presentations at scientific and technical review committees
+ Implementation of clinical recommendations from all advisory and governance committees
Internal interfaces and collaboration
+ Member of the Clinical Development Leadership Team
+ Will be responsible for managing a team of approximately 50 Scientists .
+ Oversight of and collaboration with partnering functions, e.g. Clinical Operations, Research, GRA & Safety to assure an effective project related deliveries
+ Participate and/or lead enterprise initiatives
+ Maintaining effective oversight of quality in conjunction with appropriate Quality functions
External-scientific
+ Enhancing the reputation of the Company through a culture of scientific integration of the department with the scientific community and other partners through visible publication record, KOL interactions, presence at scientific conferences, membership of consortia and similar medico-scientific groups, builds networks with scientific experts
+ Ensures that the patient and health-care provider voice is integrated into CSL's development mindset
Building a culture of risk taking, innovation and peer review across the clinical function
Providing clinical scientific and medical writing leadership throughout CSL
Providing support and insight into business development opportunities as required
**Your skills & experience**
+ Graduate level degree (M.Sc, PhD, MD etc) preferred.
+ 10 years+ of Pharma experience in clinical development
+ Clinical Scientist experience across all phases of development, FIH, POC, late-stage development and life cycle management.
+ Medical writing experience.
+ Strong track record of leadership skills.
+ Enhanced organizational awareness and the ability to interact and influence from the team level to senior management
+ Extensive experience of leading teams and/or line managing a group(s)
\#LI-Hybrid
**About CSL Behring**
CSL Behring 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. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at ************************** .
**Our Benefits**
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL (********************careers/your-well-being) .
**You Belong at CSL**
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.
To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging
**Equal Opportunity Employer**
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement .
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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. ************************************************