Research Scientist

• Direct CDx/IVD development projects, including associated DP efforts when needed, within Translational Oncology
• Lead cross-functional CDx (and where relevant, DP) development teams for various assets/biomarkers (including Regulatory, Commercial, Business Development, Project Management, Operations, Clinical Development, Statistics, Bioinformatics, Alliance Management, etc.) to drive the implementation of Dx projects and coordinate the work conducted with our external Dx partners.
• Interface directly with scientists and physicians in discovery sciences, early-stage clinical development, and late-stage clinical development, as well as other PDT & ADT members, to craft the project team’s CDx (and associated DP if relevant) development strategy.
• Lead the selection of appropriate assays and Dx platforms for the execution of biomarker strategies.
• Lead digital pathology efforts as needed for each individual CDx project
• Serve as a subject matter expert within our Company, collaborating with project teams, biomarker leads, clinical operations, and regulatory affairs on the implementation of global CDx assay strategies in global clinical trials.
• Participate in preparation of Dx-related regulatory documents including, for example, pre-submissions, briefing books, IDEs, IVDR PSAs, PMAs.
• Participate in meetings with global regulatory agencies to provide CDx expertise.
• Provide CDx input into early-stage oncology programs.
• Assist in the transfer of assays from in-house efforts to in vitro Dx companies.
• Provide CDx expertise/assessment for due diligence teams.
• Evaluate relevant new technologies including possible design/execution of pilot studies with Dx vendors.
• Perform operational tasks required to execute assigned projects as needed, e.g. ordering samples, QC of incoming clinical trial biomarker results, assay/data transfer troubleshooting, etc.

Principal Scientist, Companion Diagnostics, Translational Oncology

Architect

• Collaborate with stakeholders to gather, document, and analyze business requirements
• Develop a deep knowledge of core systems to locate appropriate process data
• Partner with data owners to identify data sources that can be leveraged in process models
• Produce process models using relevant applications
• Demonstrate process models and data driven recommendations to end users
• Assist in modelling current-state and desired business process scenarios, applying corporate modelling standards, definitions, techniques (e.g. BPMN)
• Conduct thorough analyses of current business processes to identify inefficiencies and opportunities for solutions
• Utilize process mapping and modelling techniques to visualize workflows.

Business Architecture Specialist

Software Engineer

• Provide end-to-end automation engineering support for the Rahway, NJ FLEx Center
• Ensure the reliable and compliant operation of process automation and OT/IT systems
• Maintain automation systems in a validated, compliant state per cGMP
• Lead and participate in automation system changes, investigations, CAPAs
• Develop and execute automation change control
• Serve as site automation representative for new products and operational improvements
• Represent automation in capital projects
• Lead and coordinate installation, integration, FAT/SAT, commissioning, and qualification of new automated equipment

Senior Specialist, Engineering – Onsite

Scrum Master

• Lead and facilitate Agile ceremonies (such as daily stand-ups, sprint planning, backlog refinement, reviews, and retrospectives), coach team members on Agile principles and practices, and foster a culture of continuous improvement, transparency, and collaboration across S/4HANA PMO workstreams.
• Partner with Product Owners and key stakeholders to maintain a clear, prioritized backlog, ensure work items are well-defined and ready for execution, and align sprint goals and outcomes with overall S/4HANA program objectives and milestones.
• Proactively identify and remove impediments impacting team delivery, monitor team progress using appropriate metrics and tools, and support the identification, escalation, and mitigation of risks and issues within and across PMO workstreams.
• Support core PMO activities by maintaining accurate status reporting, RAID (risks, assumptions, issues, dependencies) logs, and other governance documentation, and provide clear visibility into sprint outcomes, delivery status, and key decisions for program leadership and governance bodies.
• Collaborate with other Scrum Masters, PMO leads, and workstream owners to manage cross-team dependencies, coordinate joint planning where needed, and help ensure integrated, end-to-end delivery across the S/4HANA program.
• Contribute to the development and execution of change management activities by helping assess change impacts, supporting stakeholder readiness efforts, and working with change management leads to integrate key messages and behavioral expectations into team ways of working.
• Support program and PMO communication efforts by providing input to communication plans, ensuring timely and clear updates to stakeholders, and reinforcing key messages related to priorities, milestones, and ways of working within assigned teams.
• Assist with planning and coordinating training and readiness activities for impacted teams by aligning training needs with program timelines, supporting logistics and materials preparation, and helping monitor readiness indicators and adoption progress within supported workstreams.

Senior Specialist, PMO Support / Scrum Master

Marketing

• Lead strategic design and development of a comprehensive customer experience strategy with a focus on improving adherence and persistence through improved predication and data driven insights.
• Identify new and innovative channels to enhance and ensure a seamless experience for patients on our products.
• Build one-of-a-kind and rich patient level data set across our ecosystem.
• Utilize customer insights and data to drive continuous improvement in our services and offerings.
• Collaborate with internal and external partners (Market Research, Data Strategy, Access, Analytics, and vendors) to develop robust frameworks for adherence reporting, performance dashboards, and insight generation.
• Consult with internal stakeholders to accelerate insight driven approaches to inform future patient adherence strategies and seamless integrations across ecosystem.
• Lead implementation of data driven frameworks to optimize customer touchpoints and reduce friction and barriers to continuing therapy.
• Initiate and oversee voice-of-customer (VOC) approaches and ensure insights drive meaningful improvements.
• Lead organizational change management for innovative behavioral based adherence frameworks and touchpoints.
• Develop and design compliant strategies with appropriate guardrails to overcome access, adherence and stay-time barriers, ensuring patients get timely support from initiation through the length of their treatment.
• Identify program level enhancements working with cross-functional partners to drive operational efficiencies and excellence.
• As a member of the US Pharma Respiratory marketing team, partner with fellow colleagues to invest in each other’s development, build a culture of inclusivity, psychological safety, transparency and stretch our collective team’s thinking by challenging the status quo for the purpose of creating stronger outcomes.

Associate Director, Marketing – Adherence, Respiratory BU

Business Operations

• Oversees strategic business transformation efforts and coordinates the execution of cross-functional global business operations processes
• Enables the effective management of the Global Data Management & Standards (GDMS) organization in alignment with GDMS and broader organizational goals
• Sets the vision for the organization and establishes the global business operations framework
• Coordinates delivery of services including headcount management; resource forecasting and algorithm management; budget and expense management; financial forecasting; operations reviews; strategic project coordination; change management; communications; and professional development
• Leads topic curation and orchestration of senior leadership team meetings and other GDMS forums including global townhalls and Data Management Center (DMC) site visits
• Serves as a cross-functional integrator, ensuring tracking and status reporting for GDMS objectives to drive alignment, risk management, and execution against strategic priorities
• Maintains and facilitates the reporting of GDMS Key Performance Indicators (KPI) and Key Quality Indicators (KQI) as part of formal operations reviews
• Develops strategies to enhance organizational value and efficiency
• Leads talent development and performance management activities for Business Operations with a focus on building a high-performing team and fostering a culture of growth and development
• Proactively engages with stakeholders to identify opportunities for innovation and continuous improvement
• Sponsors and/or leads organizational initiatives Enterprise Leadership Skills – behaviors and impact expected in this role include: Strategic Planning, Execution Excellence, Change Catalyst, Networking & Partnerships

Executive Director, Business Operations

Compliance

• Support regional implementation, adoption, and enhancement of GRACS regulatory systems and digital capabilities
• Act as primary contact (or secondary support) for regional users on system usage, business processes, and process improvement initiatives; provide user training as needed
• Understand underlying business processes; work with BPOs to adapt procedures to regional and local regulatory requirements
• Evaluate regional data, identify data quality and compliance issues, and develop/implement action plans
• Ensure timely regional input and delivery of tasks for global projects
• Contribute to regional and global projects that enable regulatory and business strategies
• Collaborate with RAI, iCMC, GRACS O.P.S, PV, and other GRACS functions to deliver regional objectives
• Translate regional needs and external changes into actionable plans aligned with the GRACS Digital Strategy; support communications and change management activities
• Provide direct support for GRACS RIIM tools
• Organize/participate in regional communication forums to share updates on processes and system changes
• Support development and delivery of global/regional regulatory training and refresher sessions

Senior Specialist, System Process & Regulatory Innovation

Customer Success Manager

• Product expertise: Develop a deep understanding of our dairy-farming technologies to effectively support customers.
• Customer acquisition: Within existing account management, approach and acquire new customers.
• Customer onboarding and training: Visit customers on-site to guide them through the onboarding process and ensure they can fully leverage the benefits of our products.
• Analysis and consulting: Understand and evaluate farm operations and provide recommendations for optimization to enable full implementation of our technology.
• Conduct operational assessments in reproduction, calf and heifer management, animal health, and milk quality.
• Ongoing support: Respond to customer inquiries about product functionality and usage via our CRM system.
• Customer retention: Build strong, long-term relationships with existing customers by understanding their individual needs and acting as their advocate within the company.
• Promote commercial activities: Identify opportunities for upselling, cross-selling, and upgrades with existing customers.
• Work closely with the sales team to promote additional products and services.
• Cross-functional collaboration: Work closely with the cross-regional Customer Success team to receive product knowledge and training and to stay up to date with our technologies.
• Promote the integration of online self-service into the local customer journey.
• Support the beta process for commercial products by identifying potential customers and providing knowledge and support.
• Events: Attend local trade fairs and/or multi-farm events as a keynote speaker to promote dairy management and the use of technology.

Senior Customer Success Manager

• Responsible for implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies
• Preparation and submission of CMC sections for commercial or new biologics products
• Assist in the development and implementation of internal regulatory strategies
• Mentoring and coaching to Sr. Scientist / Scientist in support of their assigned projects
• Lead authoring of clear, concise and effective IND / CTAs, BLAs or global post approval submissions
• Collaborate with partner groups to ensure compliance, scientific excellence, accuracy and completeness of submissions

Associate Principal Scientist – Regulatory Affairs, CMC, Biologics

Data Scientist

• Translate business needs and priorities to build analytical plans that answer business questions by providing actionable insights.
• Effectively communicating advanced analytics to stakeholders to inform business decisions.
• Communicate & collaborate effectively with cross functional teams with competencies in market research, forecasting, commercial analytics, data science, customer engagement, data strategy, population health, competitive insights, marketing operations, medical & clinical backgrounds.
• Stay current with industry trends and advancements in analytical methodologies to bring new ideas forward (including application of GenAI) that will enhance analytic capabilities of the organization.
• Contribute to innovative experiments , specifically to idea generation, idea incubation and/or experimentation, identifying tangible and measurable criteria to make meaningful improvements to the business processes and strategies.
• Derive actionable business insights from various data sources, develop clear data story, and communicate effectively to business stakeholders.

Senior Specialist, Data Science, Ophthalmology – Technology

Clinical Operations

• Provides expert strategic, scientific, and operational leadership in the planning and execution of highly complex program(s)
• Lead and direct global, cross-functional teams in end-to-end clinical development activities
• Overarching responsibility and oversight of clinical program execution
• Ensure consistency and quality across assigned portfolio
• Assist the Clinical Directors in scientific leadership/investigator initiatives including preparation of publications, meeting presentations
• May lead operational components of mergers and acquisitions

Senior Principal Scientist, Clinical Operations – Immunology

• Develop and Execute precision medicine product strategy and diagnostic Go-to-market plan to support the development & launch of our Oncology New Assets.
• Provide commercial diagnostic oversight and input on diagnostic target product profile development, partner selection, market research, business cases, etc.
• Provide input into short & long-term Business Strategy, Planning & Forecasting; lead & guide development of diagnostic strategies & tactics, positioning, messaging etc.
• Provide commercial leadership, support and expertise to Diagnostic Development Teams, Global Brand Teams, Regional & Local Marketing Organizations
• Collaborate with diagnostic partners as well as medical affairs teams to develop robust scientific communications and educational plans for Diagnostic tools supporting our oncology portfolio.

Executive Director, Global New Assets Diagnostics, Precision Medicine

Project Manager

• Provides support in the planning and startup activities related to the sourcing and contracting of an observational or non-interventional research project through collaboration with Procurement.
• Assists OR leads in the preparation of Requests for Proposals (RFPs), assisting in the bid evaluations and the review of project scopes and associated budgets.
• Proactively identifies, troubleshoots and resolves emerging challenges and works toward timely resolution.
• Provides supplier/vendor oversight to ensure timely completion of supplier tasks and input.
• Troubleshoots sourcing/study issues as they arise and work to bring to timely resolution.
• Provides support for project-level compliance reviews [e.g., Anti-Bribery and Corruption (ABC) Due Diligence, Denied Party Screening (DPS)] to uphold regulatory standards.
• Works with the supplier to provide the necessary documentation to support a Fair Market Value (FMV) assessment when required for project budgets.
• Reviews documentation before it is sent for official FMV review.
• Track the progress of projects within the FMV review cycle to ensure completion within required timelines.
• Provides input to management on process improvement initiatives to enhance efficiency and effectiveness.
• Partners closely with scientists to facilitate the budgeting process, ensuring accurate payment processing and forecasting for upcoming projects or studies.
• Monitors and tracks invoices against the established payment schedule, promptly addressing any queries related to milestone deliverables to ensure timely resolutions.
• Collaborates with Outcomes Research Scientists to provide real-time updates to the official forecast within System Analysis Program Development (SAP), reflecting the annual budget for each project accurately.
• Assists Outcomes Research Scientists with inquiries regarding the timing of invoices, acting as an effective liaison if needed between vendors and our company’s Source to Settle team to resolve issues.
• Maintains meticulous records of sourcing projects and conduct thorough analyses of sourcing and financial data to inform decision-making and enhance efficiency.
• Contributes to the formulation of the annual plan, ensuring alignment with organizational objectives and resource allocation.
• Monitors the progress of all projects, ensuring that both internal and external stakeholders are kept informed with timely updates on project status.
• Facilitates budget discussions with Executive Directors as necessary, focusing on monitoring, reviewing and mitigating financial risks associated with the organization’s projects.
• Proactively troubleshoots discrepancies or potential financial issues as they arise, conducting thorough investigations to achieve resolutions.
• Provides potential project management support for various improvement initiatives within the team, contributing to process enhancements and goal achievement.
• Creates and maintains comprehensive training documents and checklists to ensure staff are equipped with the necessary resources and knowledge.
• Oversees and maintains departmental SharePoint sites, ensuring that resources are organized, accessible, and up to date for team members.

Senior Specialist, Project Management, Research Initiation, Budget Execution

• Responsible for developing and implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies
• Leading the preparation and submission of CMC sections for commercial or new biologics products
• Provide CMC Regulatory leadership within Regulatory and on cross-functional teams
• Develop and execute detailed global regulatory submissions
• Collaborate with partner groups to ensure compliance, scientific excellence, accuracy, and completeness of submissions
• Resolve complex project issues through collaboration and provide recommendations to Regulatory CMC leadership team as appropriate.

Principal Scientist – Regulatory Affairs, CMC

Director

• Translate business needs and priorities to build analytical plans that answer business questions by providing actionable insights.
• Effectively communicating advanced analytics to stakeholders to inform business decisions.
• Communicate & collaborate effectively with cross functional teams with competencies in market research, forecasting, commercial analytics, data science, customer engagement, data strategy, population health, competitive insights, marketing operations, medical & clinical backgrounds.
• Analyze data across disparate databases/sources (including claims/EMR Data and other sources) to develop insights that inform commercial business strategies.
• Stay current with industry trends and advancements in analytical methodologies to bring new ideas forward (including application of GenAI) that will enhance analytic capabilities of the organization.
• Contribute to innovative experiments, specifically to idea generation, idea incubation and/or experimentation, identifying tangible and measurable criteria to make meaningful improvements to the business processes and strategies.
• Derive actionable business insights from various data sources, develop clear data story, and communicate effectively to business stakeholders.
• Lead and mentor a team of data scientists and business analysts (on-shore and off-shore), providing guidance on best practices in data analytics, modeling and data visualization, through the scope of a project.

MSD