Johnson & Johnson

Compliance

• Provides strategic regulatory guidance throughout product lifecycle stages.
• Leads preparation and submission of licensing, registration, and approval dossiers.
• Coordinates complex regulatory activities, including post-market modifications.
• Ensures conformance of product labeling, claims, and promotional materials.
• Develops regulatory strategies and plans for new product development.
• Reviews and approves labeling, packaging, and promotional content.
• Supports audits and inspections to ensure compliance.
• Guides and trains junior team members on regulatory processes.
• Maintains and monitors regulatory compliance across markets.
• Liaises with health authorities during inspections and inquiries.
• Tracks regulatory developments and advises on impact.
• Participates in cross-functional project teams at a leadership level.
• May supervise work of contract resources or interns.

Senior Regulatory Affairs Specialist – Vision

Risk

• Define and deploy project execution governance processes to identify, select, monitor and prioritize projects and investments for IMSC providing clarity & transparency to the portfolio across Supply Chain functions.
• Coordinate and facilitate governance to ensure the portfolio is defined, optimized and prioritized; Facilitate preparation for IMSC Governance Forums, including the IMSC Investment Review Committee (IRC) and E2E execution forums.
• Provide leadership, guidance and oversight to Project teams to facilitate reviews; drive consistency, insights, and process adherence while collaborating to ensure proactive readiness for IMSC forums.
• Compile process metrics & reporting and review decks for the IMSC forums to drive effective decision making.
• Assess the portfolio health and create insightful portfolio analysis and story-telling to lead continuous prioritization in light of constraints and execution risks.
• Continually assess and enhance governance practices to align with industry standards and best practices and enable IMSC end to end governance efficiency.
• Identify constraints impacting project execution (i.e., budget, resourcing, timing, risks) to ensure clear communication across teams.
• Drive decisions to mitigate risks and address challenges affecting the project portfolio.
• Work closely with program and project execution teams to ensure alignment with portfolio priorities and governance processes.
• Identify and drive continuous improvement across the end-to-end Project Portfolio process.
• Implement tools, reporting, and automation to improve process efficiency and the user experience.
• Develop dashboards and controls to measure process performance.
• Deliver requirements and identify efficiencies to the IMSC business processes and deployment.

Manager, IMSC Project Portfolio Governance

Manager

• Act as the primary point of contact and case manager for client, provider and customer inquiries and escalations.
• Support patients and providers with program enrollment, benefits verification and referral to specialty pharmacies.
• Conduct initial patient onboarding calls and ongoing support outreach.
• Maintain regular communication to update all parties on case status and next steps.
• Process PAP (patient assistance program) requests and re-approvals promptly.
• Refer patients to external programs as appropriate.
• Identify and document adverse events and product complaints timely.
• Independently manage an assigned territory making timely decisions for case resolution.
• Demonstrate the ability to prioritize and balance the needs of patients, HCP offices utilizing program business.
• Provide concierge-level service resolve issues efficiently and escalate when necessary.
• Collaborate with field teams, manufacturer reps, providers, and internal/external teams to resolve complex cases.
• Maintain accurate, compliant documentation and communication to support program goals.
• Uphold patient privacy laws and foster collaborative team relationships.
• Other duties as assigned.

Case Manager

• Participate in global and regional regulatory team meetings and advise the regulatory team on applicable regulatory requirements, project-specific regulatory issues as assigned.
• Develop an understanding of the regional regulatory environment, competitor intelligence, and therapeutic area.
• Assist in the preparation of meetings and act as backup for contact with Regulatory Agencies as needed.
• Ensure responses to Regulatory Agency queries are made in a timely manner, and that content is consistent with the regulatory strategy.
• Work cross-functionally, interact with internal and external colleagues with coordination between departments, and lead team meetings as appropriate.
• Advise team in required documents and submission strategies.
• Review clinical trial plans, protocols and submission plans ensuring alignment with regulatory requirements.
• Support the development and improvement of processes related to regulatory submissions.
• Provide regulatory input for and follow-up to inspections, audits, litigation support, and product complaints.
• Stay on top of current and pending approvals in assigned therapeutic areas and is knowledgeable of laws, guidelines and requirements related to those areas.
• May interact with Health Authorities (HA) regarding program-specific issues and serve as secondary HA point-of-contact to represent J&J/Janssen externally with some degree of supervision.

Senior Regulatory Affairs Professional

Sales

• 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 and tactics within the assigned customer segment
• 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

• As the global regulatory lead for assigned projects, develop and implement integrated regulatory strategies and operational plans for investigational rare disease and advanced cell therapy products within the Immunology Therapeutic Area.
• Ensure strategies are aligned with portfolio objectives, regional regulatory requirements, CMC considerations, commercial goals, and market access plans.
• Serve as the key regulatory point of contact, providing leadership and guidance across cross-functional teams to support successful development and commercialization, including providing input on implications of regulatory strategy through participation in product-related teams.
• Lead the project Global Regulatory Team (GRT) and participate in the Compound Development Team (CDT) as needed.
• Lead and/or participate in meetings with regulatory agencies as appropriate and prepare company personnel for interactions with Health Authorities (HAs).
• Ensure that responses to FDA questions are handled in a timely manner and in line with the approved product strategy.
• Lead and oversee key health authority documents (e.g., IND/CTA, meeting requests, briefing packages, responses, marketing applications) according to the strategic plan for the region and health authority commitments.
• Perform critical review of submission documents to ensure compliance with regulatory requirements.
• Negotiate and manage regional post-approval commitments and global label expansion strategies.
• Maintain an understanding of the competitive landscape (e.g., views of HAs, regulatory precedents, labeling differences and disease area-specific issues) and provide proactive strategic regulatory advice to project teams and global regulatory teams.
• Maintain working knowledge of laws, guidances and requirements related to autoimmune diseases, in addition to general regulatory knowledge and provide strategic regulatory input into clinical trial designs, labeling, risk management, and development programs to meet global and regional requirements.
• Support due diligence and business development assessments.
• Identify and resolve regulatory issues that may affect projects or organizational objectives.

Director, Global Regulatory Leader

Operations

• Own end-to-end PMO operations, ensuring robust delivery governance across all program phases, including preparation and input to governance forums.
• Lead effective Integrated Project Plan, RAID (Risks, Assumptions, Issues, Dependencies) management, CCB (Change Control Board) processes, ensuring timely identification, escalation, mitigation, and resolution aligned with program goals.
• Oversee schedule management processes, ensuring accurate, reliable, and data-driven tracking against the integrated program plan with a clear path to green status.
• Manage scope governance processes, ensuring scope changes are controlled, documented, and aligned with program objectives and stakeholder expectations.
• Drive consistent and transparent status reporting across all governance levels, ensuring clarity, accuracy, and actionable insights for decision-making.
• Champion predictive delivery outlook processes to proactively identify potential delivery risks and opportunities, enabling early intervention and course correction.
• Ensure alignment of PMO operations with organization compliance and quality standards, embedding a strong risk culture focused on identification, mitigation, and follow-through on actions.
• Manage deliverables tracking and plan governance, including change control processes, to maintain program integrity and delivery confidence.
• Ensure effective documentation of meeting minutes, action items, and follow-up to drive accountability and progress.
• Provide leadership and oversight to a diverse PMO operations team, including Deployment Leads and the Offshore PM Operations Factory, ensuring alignment of activities and consistent delivery standards across global and offshore teams.
• Lead, mentor, and coach PMO operations team members, fostering a high-performance culture focused on collaboration, continuous learning, and professional development.

Director, PMO Operations

• Own end-to-end PMO operations, ensuring robust delivery governance across all program phases, including preparation and input to governance forums.
• Lead effective Integrated Project Plan, RAID (Risks, Assumptions, Issues, Dependencies) management, CCB (Change Control Board) processes, ensuring timely identification, escalation, mitigation, and resolution aligned with program goals.
• Oversee schedule management processes, ensuring accurate, reliable, and data-driven tracking against the integrated program plan with a clear path to green status.
• Manage scope governance processes, ensuring scope changes are controlled, documented, and aligned with program objectives and stakeholder expectations.
• Drive consistent and transparent status reporting across all governance levels, ensuring clarity, accuracy, and actionable insights for decision-making.
• Champion predictive delivery outlook processes to proactively identify potential delivery risks and opportunities, enabling early intervention and course correction.
• Ensure alignment of PMO operations with organization compliance and quality standards, embedding a strong risk culture focused on identification, mitigation, and follow-through on actions.
• Manage deliverables tracking and plan governance, including change control processes, to maintain program integrity and delivery confidence.
• Ensure effective documentation of meeting minutes, action items, and follow-up to drive accountability and progress.
• Provide leadership and oversight to a diverse PMO operations team, including Deployment Leads and the Offshore PM Operations Factory, ensuring alignment of activities and consistent delivery standards across global and offshore teams.
• Lead, mentor, and coach PMO operations team members, fostering a high-performance culture focused on collaboration, continuous learning, and professional development.
• Collaborate closely with Global PMs and the Global PM Lead to ensure integrated program delivery, effective communication, and alignment of priorities across all PMO Ops team members.
• Foster strong working relationships across geographically dispersed teams to promote collaboration, knowledge sharing, and continuous improvement in PMO operations.
• Act as a key escalation point for PMO operational issues, coordinating resolution efforts with Global PMO leadership and other stakeholders.

Transcend PMO Operations Director

Vice President

• Lead and develop an area sales organization to achieve business objectives.
• Establish and sustain strategic relationships with healthcare, clinical, and business executives at targeted IDNs and facilities to maximize engagement with key decision-makers.
• Develop and implement business strategies that align with market opportunities and customer needs.
• Prioritize business opportunities, assess resource trade-offs, and drive strategic account management initiatives.
• Oversee and manage appropriate demand and access strategies tailored to account needs.
• Ensure optimal area staffing levels and drive talent acquisition, training, and development.
• Coach and mentor direct reports in strategic account management and facility-level execution.
• Collaborate cross-functionally with marketing, sales, contracting, finance, and professional education teams to ensure alignment and drive business performance.
• Monitor healthcare industry trends, delivery strategies, and marketplace developments to adapt business strategies accordingly.
• Foster a culture of collaboration, cross-functional accountability, and inclusivity within the organization.
• Drive data-driven decision-making and effectively leverage insights to inform strategic planning.
• Ensure compliance with business conduct policies, healthcare compliance (HCC), and other J&J policies and procedures.
• Serve as a change leader by implementing effective talent strategies and leading through transformation initiatives.

Area Vice President

• Serve as a digital product owner for PIM capabilities supporting reliability & resiliency and business development (acquisitions & divestitures).
• Partner with business process owners to define requirements, map current‑ and future‑state processes, and deliver scalable digital solutions.
• Lead the design, configuration, and deployment of PIM workflows and tools; perform hands‑on development when needed and guide technical resources.
• Enable data visibility, governance, and decision support through platforms such as Quickbase and enterprise reporting tools (e.g., PowerBI, Tableau).
• Act as a functional supply chain SME, ensuring solutions reflect real operational and business needs.
• Drive knowledge, training, and change management for PIM across IMSC, including curriculum development, standard communications, and adoption strategies.
• Establish and maintain standards, documentation, and playbooks to enable consistent ways of working.
• Engage cross‑functional stakeholders and leaders to identify improvement opportunities, prioritize enhancements, and measure solution effectiveness.
• Stay informed on emerging technologies and best practices to continuously evolve PIM capabilities.

Manager, Product Information Management Lead

Chief Marketing Officer

• Own and deliver the global roadmap and activation plan for Digital Innovation and the Surgical Outcomes program, including prioritized use cases, milestones, resourcing assumptions, launch gates, and success metrics—and ensure key deliverables are met.
• Deliver a global value proposition and messaging architecture for Surgical Outcomes across key stakeholders (clinicians, health systems, payers, patients), including evidence-based narratives and field-ready toolkits that drive adoption and scale.
• Drive cross-functional execution across R&D, Medical Affairs, Health Economics & Market Access, Regulatory/Quality, Professional Education, Commercial/Regions, and Digital/Technology teams, with clear governance, decision rights, RACI, and escalation of risks and blockers.
• Prioritize digital use cases that improve surgical pathways (pre-op optimization, education and engagement, post-op monitoring, adherence and recovery support), and deliver global requirements, launch readiness plans, and adoption measurement approaches for priority solutions.
• Deliver digital commercialization and adoption in priority markets: develop go-to-market plans, customer journeys, omnichannel activation, and enablement programs that scale globally and can be localized effectively by region.
• Run operating rhythms and performance management across the program (KPIs, dashboards, governance, risk management, cross-team dependencies, and executive reporting), and drive corrective action plans when performance is off-track.
• Build and maintain relationships with external partners and clinical stakeholders to accelerate innovation, strengthen evidence generation, and support dissemination and adoption.
• Own financial stewardship for the program by setting targets, monitoring budgets, and forecasting impact, ensuring measurable return on investment and timely course correction as needed.
• Ensure compliance with all relevant regulations, policies, and industry standards across all initiatives, including appropriate governance for digital solutions.

Global Strategic Marketing Director – Digital Innovation, Surgical Outcomes

Security Engineer

• Provide senior leadership for security strategy, operations, and risk management across APAC/China
• Oversee physical security, travel security, crisis management, and incident response across APAC markets
• Assess and mitigate regional security risks, including geopolitical, operational, and site-specific threats
• Serve as the primary security advisor to regional leadership
• Lead and develop regional security teams and external security partners
• Establish governance, standards, and metrics for security practices
• Partner with Legal, HR, Supply Chain, IT, and Business leaders for secure operations
• Manage investigations, executive protection, and crisis response activities
• Support transformation, separation, and change initiatives impacting security operations
• Manage regional security budgets, resources, and vendor relationships

Director, Global Security – APAC/China Lead

Data Scientist

• Leverage advanced machine learning and robust data engineering techniques
• Collaborate with multidisciplinary teams including toxicologists, researchers, and safety professionals
• Develop predictive models and deliver analytical solutions
• Build scalable data pipelines and transform raw experimental outputs

Principal Data Scientist – R&D DSDH – Preclinical Sciences, Translational Safety

• The Area Vice President (AVP) leads an area sales team to achieve sales targets and financial objectives.
• They are responsible for understanding and aligning with the customer’s strategic priorities at all levels (e.g., IDN and Facility levels) and developing solutions to meet both long- and short-term needs.
• The AVP fosters relationships and partners with key executive, economic, and clinical decision-makers across the business to drive growth, increase market share, and enhance customer engagement.
• The AVP will oversee business operations by leading the area sales organization and mobilizing cross-functional support resources, including Strategic Account Management, Professional Education, and Human Resources.
• They will also be responsible for implementing policies and strategies to ensure sustained business vitality and success.
• This role requires a deep understanding of the healthcare industry, the ability to navigate a matrixed organization, and the strategic acumen to drive transformation and innovation.