CSL Plasma jobs in Philadelphia, PA - 85 jobs

The PSSI Lead supports the processes associated with start-up, site monitoring, oversight and site engagement but strives to identify innovative continuous improvement opportunities with keen business analytics. They are responsible to develop and review KPI s and metrics associated with start-up, site monitoring (onsite, remote and central) and site monitoring oversight. With KPIs established, this role will need to continually monitor performance and critically assess their impact and collaborate with appropriate groups and the SMMO LT to identify trends and resolve issues and delinquencies. The PSSI Lead monitors start-up, site monitoring and oversight processes at enterprise level using dashboards and analytics; and ensures compliance through SMMO & Partner follow-up in collaboration with Clinical Compliance. The PSSI Lead represents SMMO on SOP and process reviews, determines impact and provides recommendations or process improvement suggestions as needed. Sets oversight strategies that are fit for purpose - Ensures that the monitoring oversight process is risk-based, fit for purpose and aligned with the study Compliance Oversight Plans optimizing resource availability to focus on value add tasks - Provides high-level oversight of CRO partner monitoring strategies for alignment on risk-based approaches, appropriate onsite and remote visit frequencies and percentages of source data verification and source data review - Ensures functional area monitoring (data management review, medical monitoring, statistical review, RBQM review) is appropriately coordinated within CSL and CRO Partner for transparency of issues and required action of monitoring teams. - Foster close collaboration with Clinical Compliance and Clinical Quality Assurance (CQA), Data Management and TES as point of contact for SMMO. - Champion the implementation and use of harmonized, consistent processes and standards across SMMO deliverables related to cost-effective, timely, and high-quality clinical trial data according to agreed global goals . **Main Responsibilities** Data and Business Analysis: + This role involves developing and reviewing SMMO owned operational metrics, study plan variances, and trend reports to identify issues and recommend mitigations. + Developing innovative flexible and sustainable practices to drive excellence in SMMO delivery. + Reviews start-up, monitoring, engagement and site management oversight metrics across the organization/enterprise/portfolio for trends and provides summaries and recommendations to SMMO LT to drive business practice and adoption. Processes improvement, site quality and compliance: + The PSSI Lead works closely with stakeholders proactively to ensure a consistent understanding of signals and metrics surfacing and influence the organization and CRO partners to drive process improvements and standardization. + Critically, this role collaborates with leaders at our wCRO Partners, Clinical Compliance and CQA on monitoring and oversight processes. + Responsible for working cross functionally to drive consistency and efficiencies, and identify opportunities for site related process improvement in response to, but not limited to, compliance changes, external influences such as regulatory inspections, business strategy, performance signals, feedback from stakeholders, industry benchmarks. + Serves as the initial point of contact and technical expert for questions about, monitoring and oversight related processes, systems and responsibilities. + Serves as the SMMO process point person for trending site related deviations and trend analysis, evaluating and supporting, inspection readiness, inspections and audit findings; supporting observation mgt and CAPA resolution where appropriate. + Leads discussions with tech enablement groups both within CSL and at CRO partners to optimize AI innovations around study start-up, monitoring and monitoring oversight **Qualifications and Experience Requirements** + A seasoned clinical trials expert with extensive experience in global clinical trials and site management, with a strong understanding of Good Clinical Practices (GCPs) and regulatory operations. + Minimum of 10 years experience in site monitoring or central monitoring process development. + Analytical Skills: Strong analytical thinking and problem-solving skills are essential for interpreting complex data trends and identifying risks. + Tech and systems savvy; experience of modelling and AI + Maintains scientific/operational knowledge and expertise to possess credibility to discuss with higher level management and peers. + Strong interpersonal skills - establishes strong relationships with customers + Leadership: The ability to lead discussions, build consensus, and influence cross-functional teams is important for success in this role. + Creativity and/or ability to put innovative approaches into practice in clinical development + Strategic thinking and targeted problem solving skills + Demonstrated ability to navigate and negotiate competing priorities in a challenging environment + Experience in managing processes with a continuous improvement approach + Ability to think strategically and to quickly analyze complex circumstances and problems, and to drive appropriate decisions and actions **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-269556 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. ************************************************

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** **Senior Operations Management Trainee (Senior OMT)** Are you a senior leader interested in bringing your expertise to a place where you can feel good about the work you do? Do you want to develop new skills and set yourself up for continued growth? As a **Senior Operations Management Trainee** at BioLife, you will participate in an advanced leadership development program that will take you to our plasma centers across the country. You'll travel up to 95% of the time to learn the business while networking with supportive leaders and prepare yourself for accelerated career growth. After completing the program and obtaining a Plasma Center Operations Manager role, you'll relocate to one of BioLife's locations. **Our growth is your bright future.** Opportunities to grow as a leader are within your reach. With the incredible growth of 235+ BioLife Plasma Services centers across the U.S., the future looks bright for you. When you work at BioLife, you'll feel good knowing what you do makes a difference. **_A typical day for you may include:_** + **Continuous Learning & Development:** The expedited training program lasts approximately six months. Upon completion, you'll have 12 months to obtain a Plasma Center Manager position. During this time, you'll receive hands-on experience and have mentorship opportunities. Drive your own learning plan that covers all aspects of managing our high-volume blood plasma collection facilities. + **Team Management:** You'll use your interpersonal and communication skills to cultivate a positive environment and motivate a team of diverse individuals. Provide employee feedback, conduct performance reviews, support team members' development, participate in staff planning and recruiting, and engage and retain employees. + **Career Advancement:** Work towards obtaining a Plasma Center Operations Manager position by completing the training program, networking, and building relationships across BioLife. As you progress your career at BioLife, you'll have opportunities to open and operate brand new plasma centers. + **Supportive Teamwork:** You'll work in our fast-paced, team environment; provide operational support; conduct management training; problem-solve; and communicate with senior management. + **Exceptional Customer Service:** Retain donors by creating a positive donor experience. You may also assist with production. + **Travel Opportunities:** Learn from and network with BioLife team members across the country. You'll be able to return home every other weekend. **REQUIRED QUALIFICATIONS:** + **Relocation Required** upon graduation/completion of Trainee Program. You will be able to choose which location you would like to apply to. + 3-5 years of experience leading medium to large teams (20+ direct reports) + Up to 90-100% travel during the Trainee Program + Ability to walk and/or stand for the entire work shift + Willingness to travel and work at various BioLife locations across the country + Ability to work evenings, weekends, and holidays + Have a valid driver's license for the entire duration of the program + Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees + Ability to lift up 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 + Due to potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear **PREFERRED QUALIFICATIONS:** + Associates or Bachelor's Degree + Experience working with SOPs, GDP, GMP, CLIA, and the FDA + Experience working in a highly regulated or high-volume retail environment + Excellent interpersonal, organizational, technical, and leadership skills **About BioLife Plasma Services** Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll 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, all in a fast-paced, friendly environment. _BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd._ _Equal Employment Opportunity_ \#LI-Remote **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 - SC - Virtual **U.S. Base Salary Range:** $80,000.00 - $110,000.00 The estimated salary range reflects an anticipated range for this position. The actual base salary 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 base salary 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 and/or long-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 - SC - Virtual **Worker Type** Employee **Worker Sub-Type** Regular **Time Type** Full time **Job Exempt** Yes

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 (https://jobs. takeda. com/privacynotice) and Terms of Use (https://www. takeda. com/terms-and-conditions/) . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Senior Operations Management Trainee (Senior OMT) About BioLife Plasma Services Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll 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, all in a fast-paced, friendly environment. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. Equal Employment Opportunity Are you a senior leader interested in bringing your expertise to a place where you can feel good about the work you do? Do you want to develop new skills and set yourself up for continued growth? As a Senior Operations Management Trainee at BioLife, you will participate in an advanced leadership development program that will take you to our plasma centers across the country. You'll travel up to 95% of the time to learn the business while networking with supportive leaders and prepare yourself for accelerated career growth. After completing the program and obtaining a Plasma Center Operations Manager role, you'll relocate to one of BioLife's locations. Our growth is your bright future. Opportunities to grow as a leader are within your reach. With the incredible growth of 235+ BioLife Plasma Services centers across the U. S. , the future looks bright for you. When you work at BioLife, you'll feel good knowing what you do makes a difference. A typical day for you may include: * Continuous Learning & Development: The expedited training program lasts approximately six months. Upon completion, you'll have 12 months to obtain a Plasma Center Manager position. During this time, you'll receive hands-on experience and have mentorship opportunities. Drive your own learning plan that covers all aspects of managing our high-volume blood plasma collection facilities. * Team Management: You'll use your interpersonal and communication skills to cultivate a positive environment and motivate a team of diverse individuals. Provide employee feedback, conduct performance reviews, support team members' development, participate in staff planning and recruiting, and engage and retain employees. * Career Advancement: Work towards obtaining a Plasma Center Operations Manager position by completing the training program, networking, and building relationships across BioLife. As you progress your career at BioLife, you'll have opportunities to open and operate brand new plasma centers. * Supportive Teamwork: You'll work in our fast-paced, team environment; provide operational support; conduct management training; problem-solve; and communicate with senior management. * Exceptional Customer Service: Retain donors by creating a positive donor experience. You may also assist with production. * Travel Opportunities: Learn from and network with BioLife team members across the country. You'll be able to return home every other weekend. REQUIRED QUALIFICATIONS: * Relocation Required upon graduation/completion of Trainee Program. You will be able to choose which location you would like to apply to. * 3-5 years of experience leading medium to large teams (20+ direct reports) * Up to 90-100% travel during the Trainee Program * Ability to walk and/or stand for the entire work shift * Willingness to travel and work at various BioLife locations across the country * Ability to work evenings, weekends, and holidays * Have a valid driver's license for the entire duration of the program * Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees * Ability to lift up 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 * Due to potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear PREFERRED QUALIFICATIONS: * Associates or Bachelor's Degree * Experience working with SOPs, GDP, GMP, CLIA, and the FDA * Experience working in a highly regulated or high-volume retail environment * Excellent interpersonal, organizational, technical, and leadership skills About BioLife Plasma Services Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll 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, all in a fast-paced, friendly environment. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. Equal Employment Opportunity #LI-Remote BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. W e are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - PA - Virtual U. S. Base Salary Range: $80,000. 00 - $110,000. 00 The estimated salary range reflects an anticipated range for this position. The actual base salary 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 base salary 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 and/or long-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 - PA - Virtual Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes

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

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. ************************************************

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. ************************************************

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 (https://jobs. takeda. com/privacynotice) and Terms of Use (https://www. takeda. com/terms-and-conditions/) . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Senior Operations Management Trainee (Senior OMT) About BioLife Plasma Services Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll 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, all in a fast-paced, friendly environment. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. Equal Employment Opportunity Are you a senior leader interested in bringing your expertise to a place where you can feel good about the work you do? Do you want to develop new skills and set yourself up for continued growth? As a Senior Operations Management Trainee at BioLife, you will participate in an advanced leadership development program that will take you to our plasma centers across the country. You'll travel up to 95% of the time to learn the business while networking with supportive leaders and prepare yourself for accelerated career growth. After completing the program and obtaining a Plasma Center Operations Manager role, you'll relocate to one of BioLife's locations. Our growth is your bright future. Opportunities to grow as a leader are within your reach. With the incredible growth of 235+ BioLife Plasma Services centers across the U. S. , the future looks bright for you. When you work at BioLife, you'll feel good knowing what you do makes a difference. A typical day for you may include: * Continuous Learning & Development: The expedited training program lasts approximately six months. Upon completion, you'll have 12 months to obtain a Plasma Center Manager position. During this time, you'll receive hands-on experience and have mentorship opportunities. Drive your own learning plan that covers all aspects of managing our high-volume blood plasma collection facilities. * Team Management: You'll use your interpersonal and communication skills to cultivate a positive environment and motivate a team of diverse individuals. Provide employee feedback, conduct performance reviews, support team members' development, participate in staff planning and recruiting, and engage and retain employees. * Career Advancement: Work towards obtaining a Plasma Center Operations Manager position by completing the training program, networking, and building relationships across BioLife. As you progress your career at BioLife, you'll have opportunities to open and operate brand new plasma centers. * Supportive Teamwork: You'll work in our fast-paced, team environment; provide operational support; conduct management training; problem-solve; and communicate with senior management. * Exceptional Customer Service: Retain donors by creating a positive donor experience. You may also assist with production. * Travel Opportunities: Learn from and network with BioLife team members across the country. You'll be able to return home every other weekend. REQUIRED QUALIFICATIONS: * Relocation Required upon graduation/completion of Trainee Program. You will be able to choose which location you would like to apply to. * 3-5 years of experience leading medium to large teams (20+ direct reports) * Up to 90-100% travel during the Trainee Program * Ability to walk and/or stand for the entire work shift * Willingness to travel and work at various BioLife locations across the country * Ability to work evenings, weekends, and holidays * Have a valid driver's license for the entire duration of the program * Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees * Ability to lift up 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 * Due to potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear PREFERRED QUALIFICATIONS: * Associates or Bachelor's Degree * Experience working with SOPs, GDP, GMP, CLIA, and the FDA * Experience working in a highly regulated or high-volume retail environment * Excellent interpersonal, organizational, technical, and leadership skills About BioLife Plasma Services Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll 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, all in a fast-paced, friendly environment. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. Equal Employment Opportunity #LI-Remote BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. W e are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - NJ - Virtual U. S. Base Salary Range: The estimated salary range reflects an anticipated range for this position. The actual base salary 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 base salary 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 and/or long-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 - VirtualUSA - NJ - Deptford, USA - NJ - Egg Harbor Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes

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.

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. ************************************************

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.

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 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 answer phones, and greet and focus on our donors, while ensuring the safety of donors and our team. · You will screen new and repeat donors and take and record donor vital signs and finger stick results. · You will use our Donor Information System, prepare donor charts, maintain accurate records, and coordinate donor compensation. · You will help identify operational opportunities for continuous improvement and initiate changes to center processes using company approved procedures. · You will be there for our donors, which includes working a variety of shifts, Saturdays and Sundays, and holidays. **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:** $19.00 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._ **Locations** USA - NJ - Deptford **Worker Type** Employee **Worker Sub-Type** Regular **Time Type** Full time **Job Exempt** No

The Director, Medical Affairs Statistics will support product marketing by generation of scientifically valid evidence that goes beyond the product label. The successful incumbent will serve the knowledge needs of patient and prescriber communities that go beyond the targeted focus of regulators. **Responsibilities and Accountabilities:** + Advising, planning and execution of exploratory analyses for secondary publications + Input in CRO selection and participation in governance; direct and supervise programmers and CROs in the execution of exploratory analyses + Statistical leadership and strategic partnering with key stakeholders for the design and analysis of registry trials and RWE (Real World Evidence) studies initiated by the commercial organization, including building strong relationships with quantitative counterparts in key partner organizations + Statistical leadership and strategic partnering with key stakeholders for life-cycle-management (LCM) clinical trials initiated by the commercial organization; evaluate alternatives to traditional randomized clinical trials that make use of electronic health records, insurance claims databases, and/or registries in support of key messages + Evaluate statistical validity of proposals for investigator sponsored trials, and advise on reasonable improvements to ensure the highest quality of published evidence. + Develop, assess and conduct training in basic statistical methods and topics as needed + Put in place processes and tools that ensure reproducibility of all published results providing stewardship for data integrity and archival + Coordinate additional analyses of clinical data needed for local value propositions and market access + Agile use of our in-house RWE facility for tactical insights and feasibility analyses **Qualifications:** **Education** + A graduate degree in Statistics, Epidemiology, or related field is required; Ph.D. preferred. **Experience** + A track record of contributions to and leadership in collaborative medical/clinical research + At least 12 years of industry experience, of which at least 7 years of experience in Medical Affairs or other market facing organizations **Competencies** + Demonstrated use of innovative / creative statistical methodology for exploratory statistical analyses of clinical data + Profound knowledge of clinical data + Ability to think out of the box of regulatory requirements + Familiar with causal inference based on observational data + Comfortable around M.D.s, both internal and external to the company + Strong interpersonal and communication skills (verbal and written in English) + A solutions oriented mindset + Hands-on programming skills in SAS / R **Working Conditions** + This is a hybrid position. Three in-office days per week are required with one of these days including a Monday or Friday. **Travel Requirements** + Occasional travel to scientific conventions **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-265562 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. ************************************************

**Marketing Intern - HIZENTRA (Immunoglobulin Franchise) (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 HIZENTRA brand within the Immunoglobulin (IG) Franchise, you will gain hands‑on experience contributing to marketing strategy, execution, and education initiatives in a highly patient‑centric and competitive therapeutic area. This role offers exposure to brand growth, HCP education, and commercialization efforts across two key indications: Primary Immune Deficiency (PI) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). You will report to the Marketing Director and collaborate closely with cross‑functional partners and external agencies to support marketing initiatives that educate and engage healthcare professionals. **What You'll Gain** - Ownership of meaningful, real‑world marketing projects - Exposure to healthcare professional (HCP) education and engagement strategies - Hands‑on experience supporting a leading immunology brand - Collaboration with commercial, cross‑functional, and agency partners - Mentorship and professional development throughout the internship By the end of the program, you will leave with practical experience, an expanded professional network, and a deeper understanding of how marketing supports patients and providers in the biopharmaceutical industry. **Key Responsibilities** Under the guidance of the Marketing Director, you will: - Support the evolution of the SHARE (Starting Hizentra Administration with Resources and Education) program - Identify opportunities to improve the SHARE website experience and educational content for healthcare professionals - Assist in the development and execution of marketing strategies and tactics targeting Allied Health Professionals, including Nurse Practitioners, Registered Nurses, and Physician Assistants - Support marketing materials from concept through completion to drive commercial effectiveness - Collaborate cross‑functionally with internal stakeholders and external agency partners to support patient and HCP initiatives **Qualifications** _Education_ - Rising junior or senior pursuing a bachelor's degree in Marketing, Business, Communications, or a related field _Skills & Experience_ - Currently enrolled in an undergraduate marketing, communications, or related program - Strong written, verbal, and interpersonal communication skills - Interest in digital platforms, web content, or applications preferred - Highly organized with the ability to manage multiple priorities and deadlines - Demonstrated enthusiasm, curiosity, and confidence 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-267327 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. ************************************************

The Director, Statistical Programming provides leadership and expertise in driving the development and maintenance of the CSL statistical programming capabilities which is required to meet regulatory obligations. Manages a team of programmers supporting clinical trial and integrated analyses, annual reporting, regulatory responses, publications, HTA requests and other purposes as needed within one or more therapeutic areas. The individual will work closely with the Senior Director, Clinical and Statistical Programming to advance the internal programming environment and statistical programming processes. Works closely with Statisticians to ensure that deliverables provided by internal resources or outside providers (CROs; FSP providers) are accurate and aligned with CSL standards. **Main Responsibilities** + Working with the Biometrics Programming Leadership team, assess upcoming activities and resulting resource needs and allocate projects to people to ensure high quality, timely, delivery. Ensure realistic resource planning. + Oversee the CRO delivery or manage the in-house programming of data sets, outputs, and DDT files of clinical trials and integrated analysis. + Coordinating the oversight or in-house programming of exploratory analyses, analyses to support secondary publications, response to regulatory requests, or other adhoc requests. + Manages, hires, and mentors direct reports including annual evaluations and goal setting. + As a member of the programming leadership team within biometrics, creates, maintains ensures compliance with programming process and strategy to facilitate accurate and timely analysis programming. + Help bring state of the art programming methods and tools to the organization and drive automation of delivery, including AI. + Collaborate with Biometrics and other departments to ensure transition points in process are efficient and of high quality. + Represents the company in outside professional organizations and meetings. ** ** **Qualifications and Experience Requirements** **Education** · BSc in Computer Science, Mathematics, Statistics or related area with relevant experience · Other degrees and certifications considered if commensurate with related programming experience **Experience** · At least 15 years of experience in the biotech, pharma, or CRO industries · Preferred 5 or more years of direct supervisory experience · Experience with CRO management and/or CRO work experience · Extensive understanding of clinical programming and/or statistical programming processes and standards · Advanced Experiences with statistical programming using the SAS software including development and use of SAS Macros, preferred managing team performing these activities as well · Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM) · Proven ability to work effectively both independently or in a team setting, and to meet set goals by managing own timelines · Experience in working in cross-functional, multicultural and international clinical trial teams **Competencies** · Coding in SAS, including SAS macro language · Interest and/or experience in expanding beyond SAS as the primary programming delivery tool · Experience in and passion for automatization of routine programming tasks · Broad knowledge of clinical development and processes · Strong interpersonal and communication skills (verbal and written in English), comfortable around senior management · Ability to collaboratively work and provide leadership in matrix environment · A solutions oriented mindset · Fluency in technical requirements for CDISC compatible datasets and DDT files · Presentations of programming techniques at professional conferences is a plus **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-269597 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. ************************************************

CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. You will oversees all areas of single case processing in the global pharmacovigilance database from all sources. This includes ensuring that the vendor performs case processing in accordance with regulatory guidelines, PV agreements, and the Company's SOPs, as well as responding to specific questions or queries about cases. This role develops standards and processes, with a focus on global compliance and process optimization. Oversees Medical Evaluators responsible for medical review of ICSRs. **Key Responsibilities** Oversight of Case Management Processes activities Oversight of Medical Evaluator role which completes medical review of the following ICSRs: All serious cases from all sources Non-serious cases from company-sponsored clinical study, if required Legal ICSRs (serious and non-serious) Reportable cases of combination products with device issue(s) / malfunction (serious and non-serious) Non-serious ICSRs are processed by Case Managers and reviewed for correct seriousness on an aggregate basis by Medical Evaluator Medical review includes: Review of seriousness, listedness and causality assessments Review of event terms and MedDRA coding Review of narrative for medical accuracy and consistency Assessment of the need for Quality Investigations Generation of medical follow up queries / Targeted Questionnaires Drive department-wide planning: resource, budget, and org. strategy Own case management dashboards and governance scorecards Prepare for internal and external inspections including coordination of creation of presentations Lead transformation initiatives (e.g., vendor transitions, digital tools) Monitor regulatory trends and represent PV case management in global initiatives Coordinate departmental leadership meetings and communication Pilot innovations (e.g., RPA, AI triage, tech integration) Align with Clinical, QA, Regulatory, and Safety Science functions Coordinate creation and update of SOPs Retain product and process knowledge **Skills and Education Required** Minimum of 10 years of Clinical Trial and Post-marketing Pharmacovigilance (PV) experience with 5 years of managerial/leadership experience Global pharmacovigilance database knowledge is required along with proficient knowledge of global and local regulatory rules and regulations **Qualifications and Education Required** BS/BA, RN, Pharmacist, or similar **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-263737 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. ************************************************

**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. ************************************************

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 (https://jobs. takeda. com/privacynotice) and Terms of Use (https://www. takeda. com/terms-and-conditions/) . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Senior Operations Management Trainee (Senior OMT) About BioLife Plasma Services Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll 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, all in a fast-paced, friendly environment. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. Equal Employment Opportunity Are you a senior leader interested in bringing your expertise to a place where you can feel good about the work you do? Do you want to develop new skills and set yourself up for continued growth? As a Senior Operations Management Trainee at BioLife, you will participate in an advanced leadership development program that will take you to our plasma centers across the country. You'll travel up to 95% of the time to learn the business while networking with supportive leaders and prepare yourself for accelerated career growth. After completing the program and obtaining a Plasma Center Operations Manager role, you'll relocate to one of BioLife's locations. Our growth is your bright future. Opportunities to grow as a leader are within your reach. With the incredible growth of 235+ BioLife Plasma Services centers across the U. S. , the future looks bright for you. When you work at BioLife, you'll feel good knowing what you do makes a difference. A typical day for you may include: * Continuous Learning & Development: The expedited training program lasts approximately six months. Upon completion, you'll have 12 months to obtain a Plasma Center Manager position. During this time, you'll receive hands-on experience and have mentorship opportunities. Drive your own learning plan that covers all aspects of managing our high-volume blood plasma collection facilities. * Team Management: You'll use your interpersonal and communication skills to cultivate a positive environment and motivate a team of diverse individuals. Provide employee feedback, conduct performance reviews, support team members' development, participate in staff planning and recruiting, and engage and retain employees. * Career Advancement: Work towards obtaining a Plasma Center Operations Manager position by completing the training program, networking, and building relationships across BioLife. As you progress your career at BioLife, you'll have opportunities to open and operate brand new plasma centers. * Supportive Teamwork: You'll work in our fast-paced, team environment; provide operational support; conduct management training; problem-solve; and communicate with senior management. * Exceptional Customer Service: Retain donors by creating a positive donor experience. You may also assist with production. * Travel Opportunities: Learn from and network with BioLife team members across the country. You'll be able to return home every other weekend. REQUIRED QUALIFICATIONS: * Relocation Required upon graduation/completion of Trainee Program. You will be able to choose which location you would like to apply to. * 3-5 years of experience leading medium to large teams (20+ direct reports) * Up to 90-100% travel during the Trainee Program * Ability to walk and/or stand for the entire work shift * Willingness to travel and work at various BioLife locations across the country * Ability to work evenings, weekends, and holidays * Have a valid driver's license for the entire duration of the program * Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees * Ability to lift up 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 * Due to potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear PREFERRED QUALIFICATIONS: * Associates or Bachelor's Degree * Experience working with SOPs, GDP, GMP, CLIA, and the FDA * Experience working in a highly regulated or high-volume retail environment * Excellent interpersonal, organizational, technical, and leadership skills About BioLife Plasma Services Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll 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, all in a fast-paced, friendly environment. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. Equal Employment Opportunity #LI-Remote BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. W e are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - NJ - Virtual U. S. Base Salary Range: The estimated salary range reflects an anticipated range for this position. The actual base salary 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 base salary 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 and/or long-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 - VirtualUSA - NJ - Deptford, USA - NJ - Egg Harbor Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes

The Associate Director, Corporate and External Affairs, R&D Portfolio will lead corporate and external affairs strategy for CSL's pipeline. The successful candidate will be responsible for driving communications for key pipeline milestones and clinical trials. They will serve as a strategic partner on R&D policy. They will lead issues and crisis management related to pipeline. In addition, they will strengthen the company's reputation within the Waltham biotech ecosystem and US to enhance and protect CSL's reputation and policy position. **Reporting Relationships:** + **Reports to:** Head of Corporate and External Affairs, R&D + **Direct reports to position:** 1 **Main Responsibilities and Accountabilities:** + Serve as primary business partner and strategic advisor to SVP, Portfolio Development, SVP, GRAS and VP, Portfolio and Operations Excellence to shape and communicate portfolio development strategies and milestones, ensuring alignment with business objectives and external stakeholder expectations. + Develop and execute communication plans for significant pipeline milestones, including clinical trial initiations, data readouts, and product approvals in partnership with R&D and commercial colleagues. + Oversee the creation and dissemination of clear, compliant, and timely communications regarding clinical trial progress, results, and implications for patients and partners. + Serve as a key partner to regulatory policy team providing strategic counsel on advocacy opportunities, and stakeholder engagement. + Provides leadership and oversight into the development and review of key communications materials for portfolio milestones, ensuring alignment with corporate messaging and standards. + Reputation building within Waltham biotech ecosystem and broader US: Enhance the company's reputation by engaging proactively with local biotech stakeholders, academic institutions, and industry groups, positioning the company as a leader in innovation and responsible R&D. + Proactive issues and crisis management: Identify, assess, and manage potential issues and crises affecting R&D, coordinating rapid and effective responses to protect the company's reputation and interests. + Evaluate and report on the performance of key corporate affairs activities, providing updates and analysis to leadership. + Build pride and understanding across CSL about our pipeline and build a culture across R&D that reinforces our R&D 2.0 transformation goals. + Manage budget allocations for specific projects or initiatives within the corporate affairs function, ensuring effective use of resources. + Leads and manages performance of senior manager, CEA, R&D BP **Position Qualifications and Experience Requirements:** **Education** + Bachelors degree in communications, marketing, law, public policy, journalism, public relations or business/relevant field + Ability to think critically and analytically **Experience** + 10+ years' experience in government, public affairs or communications in the life sciences industry. + Experience managing Corporate Affairs in a global environment + Understanding of corporate social responsibility principles and practice + Strong knowledge of the public policy landscape, with particular relevance to industry, manufacturing and/or the biotech and medicines sector **Competencies** + Excellent interpersonal, verbal, written and digital communication skills. + Ability to form strong working relationships with stakeholders and partners + Skills in strategic/crisis communications \# 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-266572 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. ************************************************

**Main Responsibilities & Accountabilities** -Define and maintain clinical development and operations standards, including protocol templates, CRFs, operational workflows, and data collection frameworks to ensure alignment with regulatory and scientific requirements -Lead governance of clinical standards across systems, studies, and functions to ensure consistency, compliance, and integration with clinical data standards -Collaborate with cross-functional teams (e.g., Clinical Operations, Data Management, Regulatory, IT) to embed clinical standards into clinical systems, workflows, and processes -Monitor compliance with clinical standards, identifying opportunities for process improvements and driving continuous quality enhancements -Represent the organization in external standards bodies and industry forums (e.g., CDISC, TransCelerate) to ensure alignment with global clinical development trends and best practices -Support audits, inspections, and regulatory submissions by ensuring traceability, documentation, and adherence to clinical standards -Provide training, guidance, and support to teams on clinical standards and governance practices, ensuring consistent application across clinical trials **Qualifications & Experience Requirements** -Bachelor's or Master's degree in Life Sciences, Clinical Research, or a related field -12+ years of experience in clinical development, clinical operations, or clinical data standards -Strong knowledge of clinical trial processes, regulatory requirements (e.g., ICH-GCP), and data standards (e.g., CDASH, SDTM) -Experience in governance, quality management, or standards development, with a focus on clinical trial execution and data integrity -Excellent communication, documentation, and stakeholder engagement skills, with the ability to work effectively across teams and external bodies \#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-268056 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. ************************************************