Johnson & Johnson

Compliance

• Lead and execute robust regulatory strategies and submissions for pharmaceutical products (drugs & biologics) and medical device-related (including container closure or delivery device) in Japan, ensuring compliance with local regulations.
• Author and lead relevant end-to-end submission activities delivering project milestones and maintaining compliance with local regulations.
• Provide strong leadership and mentorship, fostering a culture of excellence and collaboration.

Associate Director, Biosurgery, Regulatory Affairs

Director

• Develop and maintain relationships with current and future industry experts, including Physicians, Advanced Practice Providers, and Biologic Coordinators
• Build and manage Key Opinion Leader relationships across a select number of districts.
• Organize and manage KOL activities and events to support the brand's KOL engagement strategy.
• Identify and vet promotional speakers, coach speakers, and manage communications with promotional speakers.
• Lead or partner with home office-based teams to develop and deliver marketing and educational programs.

Associate Director, Thought Leader Liaison, Dermatology

Manager

• Drive business growth through developing strategically aligned relationships with customers
• Establish and implement cost-effective, results-based programs and innovative initiatives
• Deliver impactful business insights to solidify the competitive advantage
• Build and maintain positive, long-term relationships with key individuals at hospital level customers
• Execute initiatives pulling strategy from IDN level to hospital/account level
• Drive innovative solutions and partnerships within targeted accounts and customers
• Work with sales leaders and sales teams to increase prospects and drive closure of opportunities
• Help navigate VAC approval process for new products and influence VAC members
• Anticipate customer needs, marketplace evolutions and competitive threats
• Partner closely with the cross-functional team for overall strategy, marketing content creation and external tactics
• Effectively manage multiple priorities to support and assist advancing business strategies
• Measure and assess the impact of KOLs engagements and convey results to cross-functional teams to further refine strategies
• Articulate the complete value proposition of Shockwave Medical to Key Strategic Accounts
• Demonstrate in-depth product knowledge and ability to speak clinically to physicians at a high level
• Maintain company standards involving ethical and moral character while representing the company

Manager, Strategic Accounts – Shockwave Medical

• Drive global functional core business capability standardization, alignment, and adoption, and ensure no business disruption through program execution.
• Accountable for Global Template design for functional ERP capabilities, ensuring key business processes and capabilities are designed and deployed in an integrated and effective manner within program timelines and scope.
• In collaboration with senior leaders, ensure design aligns strategies and roadmaps; ensure ongoing integrity of global template.
• Partner with global team of Supply Chain experts in design, development, maintenance, and improvement of global business processes.
• Support establishment and implementation of process design methodology and manage cross-program process interdependencies, including relevant templates, tools, methodology, controls, cadence, and risk mitigations.
• Partner with program leads to establish integrated project plans / schedules / deliverables.
• Partner with data standards team and ensure data standards meet business capability needs.
• Partner with business adoption team to ensure change management, business readiness, site readiness, and training are delivered to meet business needs.
• Develop and facilitate functional program presentations for senior-level IM stakeholders to advise on historical and future program status.

Senior Manager, P&S GTO IM

Data Scientist

• Work with Data Science and Oncology R&D business leaders to translate AI-based enterprise business opportunities into hands on research plans.
• Includes technical execution of AI projects, including study design, technology builds that deliver scientific insights to the Oncology R&D pipeline.
• Deliver AI-solutions across a wide range of data domains for the R&D pipeline, including discovery, translational and clinical trial data.
• Serve as a key contributor to the overarching enterprise AI strategy and enable the scaling and deployment of tools aimed at the broader R&D community.
• Work with multidisciplinary teams who will model, code, test, and release ontology modules and mappings that power knowledge graph, master/reference data, analytics, and AI/LLM applications to Oncology R&D Scientists.
• Participate in a wider community of scientists standardizing biomedical data across R&D aimed at increasing AI Readiness and delivering AI solutions across a broad range of data domains.
• Evaluate and deliver external partnering opportunities to access cutting edge technologies to apply AI to diverse R&D data sets.

Director, Oncology Enterprise Data Science – R&D, Digital Health

Financial Planning and Analysis

• Act as strategic finance partner to the EMEA Plan, Source and Supplier Engineering departments
• Ensure accurate financials and lead planning and forecasting activities
• Provide actionable financial insights through performance reporting and analysis
• Lead and coordinate Opex, Capex and Inventory annual budgeting processes
• Own cost center budget vs. actual analytics and develop commentary
• Develop action plans for slow moving and obsolete inventories
• Partner with procurement for purchase price variance analysis
• Oversee physical inventory controls
• Serve as Finance lead for change requests and assess financial impact
• Manage GR/IR reconciliation and ensure month-end accuracy
• Support preparation and submission of Capital Appropriation Request

Senior Financial Analyst, BUF Supply Chain

• Lead a team to define and deliver data products addressing critical Global Development use cases (e.g., study startup, TMF metadata, operational KPIs, submission readiness).
• Define and maintain a roadmap for Global Development data products, spanning protocol development through clinical trial disclosure.
• Develop data products through agile delivery and FAIR data principles, ensuring scalability, interoperability, and reuse across Janssen functions and external partners.
• Integrate internal and external Global Development data sources, including CRO-provided datasets, performance benchmarks, and regulatory datasets.
• Contribute to the development and governance of a Global Development Ontology to enable semantic consistency across operational and regulatory domains.
• Partner with Knowledge Management, Data Product Architecture & Governance, and Master Data Management teams to ensure Global Development data products integrate seamlessly into enterprise ontologies, knowledge graphs, and catalogs.
• Collaborate with Global Development stakeholders—including Clinical, Regulatory, Medical Writing, QA, and Safety—to co-create solutions that maximize the value of development data assets.
• Lead a cross-functional team of product owners, data engineers, and Global Development domain experts.
• Define and track KPIs to measure the impact of data products on study startup times, operational insights, and regulatory compliance.

Director, R&D Data Science, Data Products

Medical writer

• Writing or coordinating clinical and regulatory documents such as, but not limited to, CSRs, IBs, protocols, summary documents, RMPs, regulatory responses, and briefing documents
• Leading cross-functional (eg, with clinical team) document planning and review meetings
• Interacting with cross-functional colleagues on document content and acting as a champion of medical writing processes and best practices
• Responsible for establishing document timelines and strategies in accordance with internal processes, with some mentorship from functional management and clinical team, as needed
• Will function as a lead writer on most compounds (or submissions, indications, or disease areas) under supervision
• Will be primary point of contact for medical writing activities for the cross-functional team (eg, clinical)
• Coach or mentor of more junior staff on document planning, processes, and content
• Provides peer review as needed
• Active participant in or lead of process working groups

Medical Writer III, Regulatory Medical Writing

• Lead the definition and execution of the data strategy for Global Development, ensuring internal and external data assets are standardized, interoperable, and ready to power analytics, AI/ML, and regulatory activities.
• Shape and deliver the Global Development data strategy aligned with enterprise R&D priorities.
• Partner with Global Functions DSDH and clinical teams, to identify data needs and opportunities.
• Collaborate and optimize in partnership with stakeholders outside R&D.
• Lead sourcing, evaluation, onboarding of external data sources.
• Build and maintain a multi-year data strategy roadmap.
• Ensure Global Development data assets adhere to internal and external standards.
• Align with industry frameworks and internal metadata standards.
• Source, evaluate, and integrate operational, regulatory, and scientific datasets from internal teams, CROs, regulators, and trusted external partners.
• Define and monitor measurable KPIs such as: Acceleration of study startup timelines, Improvement in submission readiness scores, Increase in data reuse and interoperability across programs.
• Act as a champion for Global Development data strategy across clinical, regulatory, data science, QA, medical writing, safety, and IT teams.

Senior Manager, Data Strategy

Sales

• Be responsible for attaining sales objectives
• Present complex clinical and business information on Janssen Biotech's immunology products and services
• Use discretion and judgment to execute the franchise and company brand strategy
• Influence decision makers and influencers within assigned customers
• Execute marketing strategies at the local level
• Build customer loyalty by identifying and cultivating relationships with key decision makers

Senior Immunology Sales Specialist, Dermatology

• Drive clinical development strategy, contribute to the development of other study-related materials (e.g. ADP, SAP, CSR outputs, case report forms, operational plans) and provide clinical representation for study-related review committees (e.g., first in human committee, protocol review committee).
• Lead the execution of clinical trial protocols within the clinical development program, ensuring compliance with scientific, organizational, and regulatory standards.
• Oversee end-to-end delivery of clinical trial protocols/programs, including study design, initiation, medical safety data monitoring, data dissemination, and closeout activities.
• Manage and coordinate activities with internal functional partners and external partners to ensure timely scientific and clinical execution of clinical studies.
• Maintain the quality and integrity of clinical data critical to the evaluation of study endpoints.
• Interact and collaborate with investigators and study teams during the conduct of the trial(s).
• Lead training on study protocol, disease evaluation criteria, and other essential components to enhance the understanding of clinical development processes.
• Review, interpret, and report clinical trial data, ensuring accuracy and integrity for health authority submissions.
• Draft documents for reporting clinical trial data (e.g., clinical study reports, patient narratives, investigator brochures, and periodic safety updates).
• Collaborate with Study Responsible Scientist and Study Responsible Physician to assess and evaluate clinical trial medical/safety data (i.e. adverse events, labs, medications, etc.).
• Establish and define medical data review plan in partnership with Study Responsible Physician.
• Leads and performs medical data monitoring/reporting and evaluates ongoing clinical trial data.
• In partnership with Study Responsible Physician, act as a liaison between the company and clinical investigators, fostering collaborations with key opinion leaders and external advisors.
• Develop and maintain credible relationships with internal and external stakeholders, including senior management, cross-functional trial teams, and external partners/vendors (e.g. CRO, ARO).
• Provide mentorship and training to junior team members, fostering a collaborative work environment.
• Guide and support colleagues in clinical development processes and standards.
• Identify opportunities for process improvements and drive the implementation of best practices in clinical trial execution.
• Drive innovative research methods and operational strategies to enhance clinical development efficiency.
• Collaborate with cross-functional partners to align clinical strategies with overall product development goals.
• Participate in governance meetings, as appropriate, and cross-functional initiatives to promote business strategies and process improvements.
• Prepare and present findings and results of clinical research at internal and external meetings, including regulatory body interactions and academic partners.
• May act as an author for scientific publications, as applicable, to influence clinical development practices and advancements.
• Research and review medical literature and new technologies to support operational planning and scientific strategy implementation.
• Integrate scientific and technological innovations into clinical trial designs, including biomarkers and digital health initiatives.

Director, Clinical Sciences – Oncology

Therapist

• Provide operational expertise based upon a combination of GMP knowledge of facility design, knowledge in aseptic techniques and process knowledge in development of technology either in ATMPs or equivalent industry that is transferrable to cell and gene therapy products.
• Provide operational expertise in GMP support processes, for instance, cleaning, environmental monitoring, gowning, waste, GMP documentation needs, etc.
• Translates input into operational performance efficiencies for user requirements for new technology and processes.
• Ensure completion of user acceptance testing to deliver user requirements and performance efficiencies.
• Provide operational input to the facility resource model.
• Leverage the model to shape the development and operability of GMP support processes to deliver solutions for cost competitiveness.
• Support development and implementation of change control strategy, risk assessment strategy, and qualification strategy to ensure operability and scale out considerations within the quality and regulatory requirements.
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Senior Cell Therapy Engineer

• Responsibility for representing the Corporation, including our Innovative Medicine and MedTech sectors, before a variety of legislative, administrative, regulatory, and executive levels of state government and, in some instances, local jurisdictions.
• Develop, implement, and execute strategies that inform and shape the state legislative and regulatory process to enable patient and provider access to innovative therapies and medical solutions, and that deliver business growth.
• Establish and maintain interactive contact with state and local government executive, legislative, administrative, and regulatory branches to implement strategic plans and deliver favorable public policy solutions for Johnson & Johnson, our providers, and patients.
• Develop, maintain strong relationships with J&J Facility Leaders and their teams in states where J&J has a site.
• Draft and advance legislative and regulatory policy proposals in collaboration with J&J internal partners and external stakeholders.
• Develop, maintain, and lead strong working relationships with trade, professional, and allied organizations, educational institutions, organized labor, and other stakeholders who help shape public policy at the state level, to drive J&J state priorities.
• Identify, analyze, and report to J&J businesses on legislative and regulatory issues, as well as healthcare trends and emerging issues that may have an impact on the business, and recommend and manage a course of action.
• Participate in, contribute to, and lead where appropriate, internal work streams dedicated to key issues or interests of the Corporation, Johnson & Johnson Innovative Medicine or Medtech sectors, or the J&J US State Affairs organization.
• When assigned, assume leadership responsibilities on behalf of J&J US State Affairs for key external stakeholder organizations, and develop, drive, and deliver meaningful engagements with measurable outcomes aligned with organizational objectives.
• In coordination with the appropriate internal business partners, work to identify, establish, and shape state public policies that promote favorable coverage, reimbursement, and access to our products & services in government programs.
• Implement strategies and tactics to protect, promote, and positively enhance an open business climate in the formulation of legislation and regulations by state and local entities.
• Participate, serve, and assume leadership positions on industry-related associations, steering committees, and networking organizations to protect & promote J&J interests.
• Maintain office complete with pertinent records, files, and resource materials, assuring proper business activities in reporting, planning, and advising regarding state governmental activities.
• Adhere to J&J health care compliance requirements and all applicable government lobbying laws.

Director, US State Affairs – FL, GA, SC, AL

• Educate HCPs on product coverage, prior authorizations and appeals, reimbursement processes, claims submissions, procedures, and coding requirements of payer organizations
• Collaborate with field support team members such as sales representatives and key account managers
• Act with a sense of urgency to address critical access and affordability issues for patients
• Partner with managed care colleagues to understand current policies and potential future changes
• Conduct field-based reimbursement and access support, education, and creative problem-solving
• Build strong, trust-based relationships with customers in all assigned Immunology accounts
• Manage territory logistics, routing, and account business planning
• Maintain and grow knowledge of national, regional, local, and account market dynamics
• Grow knowledge of hub and specialty distribution channels to improve practice and patient support needs
• Collaborate with internal J&J departments

Field Reimbursement Manager, Immunology – GI

• Build and maintain positive, long-term relationships with key individuals at the hospital level customers.
• Execute initiatives pulling strategy from IDN level to hospital/account level.
• Drive innovative solutions and partnerships within targeted accounts and customers.
• Work with sales leaders and sales teams to increase prospects and drive closure of opportunities.
• Help navigate VAC approval process for new products and influence VAC members
• Anticipate customer needs, marketplace evolutions and competitive threats.
• Partner closely and collaborate with the cross functional team for the overall strategy, the marketing content creation and the external tactics.
• Effectively manage multiple priorities to support and assist advancing business strategies
• Effectively identifies, engages, and manages relationships with influential individuals in the cardiovascular interventional space and fosters long-term strategic partnerships.
• Measure and assess the impact of KOLs engagements and convey results to cross-functional teams to further refine market access strategies.
• Articulate the complete value proposition (clinical, reimbursement, health economics, and pricing) of Shockwave Medical to Key Strategic Accounts.
• Demonstrate in-depth product knowledge, and ability to speak clinically to physicians at a high level.
• Maintain company standards involving ethical and moral character while professionally representing the company.
• Comply with all corporate compliance, FDA, medical device, quality standards and ethics.
• Other duties as assigned.