46 jobs found

CSL The Opportunity: This Order To Cash, Americas Lead is an integral role within global Order To Cash stream under BPO Organization. The role is accountable for both CSL's Order To Cash for Americas region, which covers all activities that consist of (but not limited to) Customer Management; Order management; EDI management; Invoice to Cash; Delivery Management; Return Processes, enterprise-wide within the Affiliate and Export fulfilment to ensure fit for purpose. This role sets up the global standard and process improvement that will bring the most value (Faster and Better) to improve both UX, productivity and CX in different markets. This role will also be responsible for making sure the global standard is enforced while ensuring the capabilities to be fully sustainable. You will analyze and measure the effectiveness of existing business processes and develops sustainable, repeatable and quantifiable business process improvements. You will Research best...

Merck Job Description The Global Senior Director Medical Affairs (GDMA) position resides in the Value & Implementation (V&I) organization, which includes GMSA as well as Outcomes Research. The GDMA is a subject-matter expert (SME) in their area of responsibility (e.g., defined tumor, asset, vaccine) and responsible for driving execution of the Global Medical and Scientific Affairs (GMSA) portion for their assigned Therapeutic Areas (TA) as part of the Global V&I Plans. As a highly specialized SME, they bring business savviness to the organization, are important decision-makers, and will have a focus on the United States (U.S.), while also supporting the rest of world (ROW). The GDMA may also be appointed as a V&I Lead for their disease/asset area, which includes additional organizationally aligned responsibilities. The GDMA works as part of a high-performing, results-driven team, focused on executional excellence. Responsibilities and Primary...

Merck Job Description The Global Senior Director Medical Affairs (GDMA) position resides in the Value & Implementation (V&I) organization, which includes GMSA as well as Outcomes Research. The GDMA is a subject-matter expert (SME) in their area of responsibility (e.g., defined tumor, asset, vaccine) and responsible for driving execution of the Global Medical and Scientific Affairs (GMSA) portion for their assigned Therapeutic Areas (TA) as part of the Global V&I Plans. As a highly specialized SME, they bring business savviness to the organization, are important decision-makers, and will have a focus on the United States (U.S.), while also supporting the rest of world (ROW). The GDMA may also be appointed as a V&I Lead for their disease/asset area, which includes additional organizationally aligned responsibilities. The GDMA works as part of a high-performing, results-driven team, focused on executional excellence. Responsibilities and Primary...

CSL 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 Associate Director, AI & Advanced Analytics? The job is in our King of Prussia, PA or Waltham, MA Office. This is a hybrid position and is onsite three days a week. You will report to the Head of MSPR. You will support the deployment and scaling of AI/ML models, digital agents, and automation solutions across R&D. Contributes to technical delivery, stakeholder coordination, and responsible governance practices to enable innovation and efficiency. Responsibilities: Support development and deployment of AI models, automation scripts, and intelligent agents. Partner with R&D teams...

Merck Job Description Our Medical Affairs team advances patient care by engaging in scientific exchange with external medical experts and industry professionals ensuring the scientific value of our products is realized. We engage and train internal employees to ensure that they thoroughly comprehend the science behind the medicine and review further unmet medical needs to bolster collaboration and further differentiate our portfolio. The Global Director Medical Affairs (GDMA) is responsible for driving execution of scientific & medical affairs plans for atherosclerosis programs in key countries and regions. They are impactful members of Product Development Team sub-teams and Global Human Health commercialization teams. They collaborate with global Commercial, Center of Real-World Evidence (CORE), Policy and Market Access to address opportunities in key countries. They contribute to the development of a single global scientific communications platform. They consolidate...

Merck Job Description Our Medical Affairs team advances patient care by engaging in scientific exchange with external medical experts and industry professionals ensuring the scientific value of our products is realized. We engage and train internal employees to ensure that they thoroughly comprehend the science behind the medicine and review further unmet medical needs to bolster collaboration and further differentiate our portfolio. The Global Director Medical Affairs (GDMA) is responsible for driving execution of scientific & medical affairs plans for atherosclerosis programs in key countries and regions. They are impactful members of Product Development Team sub-teams and Global Human Health commercialization teams. They collaborate with global Commercial, Center of Real-World Evidence (CORE), Policy and Market Access to address opportunities in key countries. They contribute to the development of a single global scientific communications platform. They consolidate...

CSL Position Description Summary: Responsible for leading the successful operational delivery of global, cross-functional Tech Ops projects of strategic importance to CSL's product portfolio. Main Responsibilities & Accountabilities: Work closely with project leader to define strategy and operational tactics Responsible for the preparation and management of project budgets, sensitivities, resources, project timelines, project scope and all other project documentation Accountable for the accuracy and quality of reports to senior stakeholders Lead cross functional development teams through tactical execution of project plans Identify, manage and resolve project issues and mitigate risks Ensure documentation of key team information, decisions, actions, modifications to scope, resources, timelines and milestones in project management systems is current. Identify, evaluate the critical path, scenarios and challenge assumptions to increase robustness of project plans...

CSL The Opportunity: The Head of Clinical Trial Quality Assurance role maintain and enhance the Global Clinical Trial Quality System supporting Early to Late-stage clinical development projects within R&D, utilizing and improving the existing R&D Quality Management System in alignment with CSL overarching Quality Management System administered and managed by Global Quality. This position strategically oversees aspects of the R&D Quality Management in relation to key quality elements such as Document Management, Knowledge Management, Significant Issue / Serious Breach Management, Deviation and CAPA Management, Risk Management, Continuous Improvement, Inspection Management, Change Management and R&D Quality Governance associated with R&D clinical development. The role manages a Global Clinical quality department supporting early and late-stage clinical trials for all CSL business units across all R&D anchor sites. Develop and maintain an...

CSL Position Description Summary Responsible for leading the successful operational delivery of global, cross-functional R&D projects of strategic importance to CSL's product portfolio. Main Responsibilities & Accountabilities Work closely with project leader to define strategy and operational tactics Responsible for the preparation and management of project budgets, sensitivities, resources, project timelines, project scope and all other project documentation Accountable for the accuracy and quality of reports to senior stakeholders Lead cross functional development teams through tactical execution of project plans Identify, manage and resolve project issues and mitigate risks Ensure documentation of key team information, decisions, actions, modifications to scope, resources, timelines and milestones in project management systems is current. Identify, evaluate the critical path, scenarios and challenge assumptions to increase robustness of project plans...

CSL CSL is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat hemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency, dialysis, and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL - including our three businesses, CSL Behring, CSL Seqirus and CSL Vifor - provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. Program Experience: CSL's Internship Program is a hands-on experience that showcases the daily innovation and operations of a leading biotechnology company. Our environment is collaborative, global, and purpose-driven. The 12-week experience will immerse...

CSL This position will lead the transformation of project leadership capabilities across the R&D enterprise. On a systemic level, this role will prepare critical GPL roles (Exec Directors) to be CEO of the project via a bespoke leadership/drug development/executive training and coaching program which will equip these leaders and associated project teams to navigate ambiguity, prioritize effectively, and make high-impact R&D investment decisions that accelerate innovation and deliver value to patients. This position will work with the CEO/GLG, RDLT and all levels to ensure the Project Operating Model is continuously improved for simple, rapid, empowered, project-centric decision making at the right level. This role will also lead the leadership development of Project Managers (PMs) and Research Project Leads (RPLs) in R&D and strengthen the GPL/GPM partnership. Main Responsibilities & Accountabilities *Develop and run an executive...

CSL The Lead, Global Regulatory Affairs Device is responsible for: Developing, coordinating and implementing global Software as a Medical Device regulatory strategies for new combination and standalone medical devices. Ensure worldwide regulatory device compliance and successful market access across all regions. Closely collaborate with internal stakeholders on regulatory strategy issues, develop approaches to address regulatory and compliance matters, serve as primary liaison to the US FDA for device matters, and closely work regional regulatory staff to engage with international health authorities. Represening CSL in official device regulatory capacities and acting as an authorized official or responsible person in interactions with regulatory agencies. This role promotes strong cross-functional collaboration and effective communication across Global Operations, Plasma Operations, R&D, Global Regulatory Affairs, and other relevant CSL business functions to...

CSL The Lead, Global Regulatory Affairs Device is responsible for: Partnering closely with R&D, Manufacturing, Operations, Quality, and Regulatory Affairs stakeholders to address regulatory strategy challenges and deliver innovative, timely regulatory solutions that meet evolving device regulatory and compliance requirements for plasmapheresis devices, drug device combination products, standalone drug delivery devices, and ancillary devices. Ensure worldwide regulatory device compliance and successful market access across all regions. Closely collaborate with internal stakeholders on regulatory strategy issues, develop approaches to address regulatory and compliance matters, serve as primary liaison to the US FDA for device matters, and closely work regional regulatory staff to engage with international health authorities. Represening CSL in official device regulatory capacities and acting as an authorized official or responsible person in interactions with...

CSL The Senior Manager, R&D Outsourcing is responsible for managing the full contracting lifecycle for strategic outsourced R&D services and projects across assigned therapeutic and functional areas. This includes drafting, reviewing, and negotiating scopes of work, budgets, and contracts with external service providers to support CSL's global clinical and portfolio development needs. This individual contributor role partners closely with Business Strategy Leads, Project Owners, Legal, Finance, and Procurement to ensure timely contract execution, cost control, and compliance with CSL's policies and standards. Outsourcing Execution Manage vendor identification, RFI/RFP processes, proposal reviews, and budget and contract negotiations for strategic outsourced R&D services (e.g., MSAs, Work Orders, Change Orders, rate cards). Draft, review, and finalize contracts to ensure timely execution and compliance with CSL policies. Coordinate with project teams and...

CSL Position Purpose The Head of Global Regulatory Affairs Device is responsible for: Providing strategic leadership and operational oversight for the Global Regulatory Affairs Device function. Leading the global regulatory strategy and execution for CLS's medical device portfolio during development and post-approval lifecycle, including plasmapheresis devices, blood establishment computer software (BECS), drug device combination products, standalone drug delivery devices, ancillary devices, and software as/in a medical device (SaMD/SiMD). Ensure worldwide regulatory device compliance and successful market access across all regions. Closely collaborate with internal stakeholders on regulatory strategy issues, develop approaches to address regulatory and compliance matters, serve as primary liaison to the US FDA for device matters, and closely work regional regulatory staff to engage with international health authorities. Represening CSL in official...

CSL The Global Regulatory Affairs CMC - Decision Support Lead is responsible for: Providing comprehensive administrative support to the Head of Global Regulatory Affairs CMC to enable the Head of Global Regulatory Affairs CMC to focus on strategic priorities and organizational leadership. This role requires exceptional attention to detail, strong communication skills, maintaining the highest level of confidentiality, and the ability to manage multiple priorities simultaneously. Providing targeted administrative support to the Global Regulatory Affairs CMC leadership team, ensuring the efficient operation of departmental activities. Tracks departmental business actions, goals, objectives, KPIs, and commitments to internal stakeholders. Supports the Head of Global Regulatory Affairs CMC in department-wide resource planning and forecasting through data-driven resource analysis. Partners with finance, HR, and project managers to support workforce planning, hiring...

CSL Reports to: Associate Director, Clinical Trial Business Operations Position Summary The Senior Manager, Clinical Trial Business Operations (CTBO) oversees CRO execution of investigator site budgets, contracts, site payments, and ICF deliverables. This role is also responsible for coordinating clinical trial insurance needs and supporting Sunshine Act/transparency reporting requirements. The Senior Manager ensures operational consistency, manages escalations, and contributes to compliance, quality, and governance activities. Key Responsibilities CRO Oversight Review and oversee CRO work related to budgets, contracts, payments, and ICFs. Ensure accuracy, quality, and alignment with internal templates, processes, and parameters. Provide operational guidance to CRO teams to ensure consistency across regions and studies. Escalation & Issue Management Manage escalations exceeding CRO negotiation authority. Partner with Clinical Operations,...

CSL The Senior Manager, R&D Outsourcing is responsible for managing the full contracting lifecycle for strategic outsourced R&D services and projects across assigned therapeutic and functional areas. This includes drafting, reviewing, and negotiating scopes of work, budgets, and contracts with external service providers to support CSL's global clinical and portfolio development needs. This individual contributor role partners closely with Business Strategy Leads, Project Owners, Legal, Finance, and Procurement to ensure timely contract execution, cost control, and compliance with CSL's policies and standards. Outsourcing Execution Manage vendor identification, RFI/RFP processes, proposal reviews, and budget and contract negotiations for strategic outsourced R&D services (e.g., MSAs, Work Orders, Change Orders, rate cards). Draft, review, and finalize contracts to ensure timely execution and compliance with CSL policies. Coordinate with project teams and...

CSL The Associate Director (AD), Biostatistics, leads the full scope of statistical contribution to a clinical development program. The AD provides statistical strategies for the clinical trials and regulatory submissions, and is accountable for the statistical deliverables within the program. 1 Lead full scope of Biostatistics conduct for the responsible program within a therapeutic area. Define statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions 2 Influence and contribute to clinical development plans, collaborate with cross-functional team for governance reviews. Lead statistical strategy for planning and study execution (member of Study Executive Team, Clinical Development Team) and quantitative evaluation to clinical trials, regulatory submissions, and related documents. 3 Provide statistical thought partnership for innovative study design and clinical development...

CSL This role is based out of our King of Prussia Office Location Responsibilities: Associate Product Manager will help assist in the development and execution of tactics to advance brand strategy and achieve commercial objectives. This individual will support the Brand Director, and other members of the Brand Team, in implementing and managing key projects and initiatives for ANDEMBRY. The ideal candidate will thrive in a fast-paced environment, have strong project management and collaboration skills, as well as be able to work individually and part of a team. This person should have confidence in regularly interacting with key stakeholders (Sales, Healthcare Systems, Medical, etc.) and be able to work collaboratively. Main Responsibilities: Manage all brand-owned assets within the Veeva system to ensure timely delivery and proactively communicate updates or changes across all partners Lead HCP contracting administrative process and ensure knowledgeable on...