Johnson & Johnson

Risk

• Actively participates in all study activities, contributing to the identification and assessment of key risks in the clinical protocol/set-up and advising clinical team members on effective mitigation strategies
• Participates in regular review of risk areas in collaboration with Risk Owners, to evaluate progress of risk mitigations and risk reduction, and to identify potential new risks or additional mitigation needs (trial and/or compound, as assigned)
• Maintains CQP (Clinical Quality Plans) in quality repository to facilitate regular progress reviews of quality support services in addition to risks and mitigations
• Collaborates closely with risk owners in evaluation of mitigation actions and effectiveness checks on mitigations
• Communicates and facilitates risk updates to R&D colleagues as part of the regular review cycle through Quality Working Groups and Governance Fora, as applicable (trial and/or compound, as assigned). Highlight new potential systemic risks to RDQ CRM management
• Develops and ensures a consistent interpretation of issues that require quality investigations
• Provides guidance for significant quality issues (SQI) per corporate standards and escalates SQI to R&D management.
• Provides initial serious breach evaluation of quality issue that may require reporting to Health Authorities
• In collaboration with partners in RDQ, provides advice on the development and implementation of Corrective and Preventative Action (CAPA) Plans and Effectiveness Checks (Self - Identified, Inspection, Audit)
• Supports proactive inspection readiness activities throughout the study with trial teams to develop ongoing trial oversight, inspection narratives, identify and prepare sites of interest for inspection (including, pre-inspection visit support), ensures availability of key documents/records and coordinates mock inspection in collaboration with Regulatory Compliance teams.
• Provides support for Investigator, Sponsor-Monitor and third-party inspections including post inspection support
• Provides advice on questions related to research quality and compliance from Business Partners in collaboration with other Quality Professionals and Subject Matter Experts to ensure consistent interpretation of international regulations and policy.

Risk Management Specialist – Oncology

Manager

• Provide oversight and execution of Electrophysiology Professional Education activities.
• Under the strategic direction of the Senior Manager, U.S. Professional Education, will work in close collaboration with business partners, primarily Global Education and US Commercial Marketing Teams, to ensure oversight and execution of all U.S. professional education programs as well as development of educational resources for health care professionals, helping to enable Electrophysiology to be recognized as best in industry for clinical performance and knowledge dissemination.
• Provide oversight of the design, development, and delivery of US Professional Education programs in multiple locations and settings, incorporating stakeholder input and support (including Health Care Compliance, Medical Science, Therapy Advancement, and Commercial Marketing).
• Play a key role in assigned JJMT EP Field Area to ensure health care professional education learning journeys, product training needs, and key business initiatives are met.
• Manage budget, costs, and materials, including oversight of administrative support for event planning and post training closure.
• Develop and equip designated education leads and J&J MedTech EP personnel with educational program information (including standards of practice and event logistics) and tools for effective engagement with health care professionals.
• Manage processes to identify US education gaps, develop learning continuums, assess effectiveness and outcomes of programs via direct and indirect feedback.
• Seek opportunities for strategy and process improvements.
• Oversee submission and preservation of all content for copy approval and compliance.
• Collaborating Electrophysiology U.S. Professional Education teammates to support all Professional Education Programs.
• Communicate business related issues or opportunities to next management level.

Manager, Professional Education – Electrophysiology

Director

• Provide strategic direction and governance for the global TPRM program as the BPO, establishing policies, procedures, and oversight structures to manage third-party intermediary risks enterprise-wide
• Set global standards and drive consistency across all regions while accommodating local regulatory requirements
• Develop and maintain a risk-based segmentation and assessment framework for third parties
• Oversee robust pre-engagement due diligence processes to identify potential anti-corruption red flags or compliance issues before onboarding new third-party intermediaries
• Ensure due diligence depth is commensurate with the third party’s risk profile
• Partner with Legal in providing contractual safeguards
• Partner with IT and digital teams to define requirements and implement technology solutions to increase efficiency and effectiveness of TPRM processes
• Continuously evaluate new tools and drive enhancements to keep the program current with best practices and evolving risks
• Drive development of data analytics and reporting capabilities to continuously measure and improve the TPRM program.

Director, 3rd Party RM – Program

Account Executive

• Identify and qualify prospective surgeons and accounts
• Develop and implement account or surgeon-specific plans and selling strategies to grow sales and convert new business
• Achieve Business Plan Objectives and sales goals/quotas through accurate use of approved resources
• Drive product sales for all assigned products within an assigned territory or set of named accounts
• Use product and customer knowledge to present, demonstrate, and ensure proper utilization of products
• Gain access to the right surgeons and buyer points within an account
• Build effective customer relations with key surgeons, operating room personnel and other pertinent hospital personnel
• Maintain appropriate surgeon/resident contact with all prospects or newly converted customers
• Routinely provide support to surgeons and OR personnel during surgical cases
• Strive to improve care for our patients
• Service customer as a problem solver and maintain excellent response time and follow-up
• Routinely educate Surgeons, OR and Central Supply Personnel through in-services and workshops
• Maintain JnJ sales equipment and promotional materials in proper condition and use them to support territory efforts consistent with company policies and procedures
• Handle and prioritize competitive threats as appropriate
• Actively promote new or special emphasis products and strategic selling objectives
• Implement a plan to achieve a balanced product sales mix in assigned territory

Sales Consultant, Sports

Compliance

• Lead and manage source regulatory compliance activities across APAC, ensuring adherence to regulatory and quality system requirements
• Provide regulatory compliance oversight for suppliers, contract manufacturers, and externally provided processes
• Partner with Supply Chain, Procurement, Quality, and Regulatory Affairs teams to support compliant supplier qualification, monitoring, and lifecycle management
• Interpret regional and country‑specific regulatory requirements and translate them into sourcing and supplier compliance expectations
• Support internal audits, external audits, and health authority inspections related to sourcing and supplier compliance
• Monitor compliance risks, trends, and supplier performance metrics; drive corrective and preventive actions
• Ensure consistent application of global and regional compliance policies, procedures, and controls across APAC
• Drive continuous improvement initiatives to strengthen sourcing compliance governance and effectiveness

Manager, Source Reg Compliance – APAC

• Provide regional leadership and oversight for FM services across EMEA & APAC
• Ensure delivery of globally standardized FM services adapted to local regulatory and operational requirements
• Act as the primary regional integrator between Global FM, E&PS, regional leadership, and outsourced service providers
• Own vendor relationships and performance across a fragmented supplier landscape
• Serve as the senior escalation point for FM service delivery, compliance, infrastructure resilience, and operational continuity
• Ensure regulatory compliance and audit readiness across diverse legal, safety, environmental, and labor frameworks
• Translate global FM and E&PS strategies into regionally executable plans
• Provide strategic FM input into capital projects, site transitions, and separation-related activities
• Lead crisis management participation across the region

Director, FM EMEA – APAC

• Support APAC trade compliance activities in alignment with global trade policies and regional regulatory requirements
• Review, prepare, and maintain accurate trade and customs documentation to support import and export transactions
• Monitor compliance with customs regulations, trade controls, and internal procedures across APAC markets
• Partner with logistics providers, customs brokers, and internal stakeholders to resolve trade-related issues
• Assist with classification, valuation, country of origin, and other trade data requirements
• Support internal audits, compliance reviews, and regulatory inquiries related to trade activities
• Maintain accurate records and data within trade compliance and ERP systems
• Analyze trade data and identify trends, risks, or opportunities for process improvement

Trade Compliance Analyst, APAC

QA Engineer

• Provide operational leadership for quality assurance and regulatory affairs supporting the Hong Kong market.
• Ensure regulatory compliance and effective quality management system execution.
• Partner with local market stakeholders, regional leadership, and Global QARA teams to support product lifecycle activities.
• Coordinate regulatory submissions, technical documentation, and responses to health authority inquiries.

Manager, QARA

• Project manage tender submission with sales, marketing and Corporate Account leaders
• Conduct Risk Assessment for input into Bid/No-bid decisions
• Establish project plans and time schedules
• Manage Bid clarifications and negotiations with customers

Bids & Contracts Manager

• Support execution of EMEA HEMA strategies and priorities at regional level
• Work in close partnership with country to support aligned country execution
• Coordinate EMEA initiatives, timelines, and deliverables across countries
• Support EMEA evidence generation activities including health economic analyses and real-world evidence initiatives
• Contribute to development, rollout, and localization of EMEA value messages, tools, and access materials
• Provide hands-on HEMA support to assigned countries or clusters
• Collaborate cross-functionally with Marketing, Medical/Clinical, Regulatory, and Commercial teams
• Support deployment of HEMA tools, templates, and training materials across countries
• Ensure compliance with EMEA HEMA governance, quality, ethics, and regulatory standards

Associate Manager, HEMA

Marketing

• Support global brand strategy by helping ensure clarity, consistency, and appropriate application across markets
• Assist in translating global brand direction into regionally relevant approaches across EMEA, APAC, and the Americas
• Gather and share market insights with brand leaders to inform product development and brand strategy initiatives
• Serve as a key point of coordination between global brand teams and priority market leaders
• Support priority markets in adapting global strategies to local needs, regulations, and market dynamics
• Enable markets with approved modular content, guidance, and tools to support brand presence and engagement
• Help maintain consistency in digital presence, congress participation, and brand expression across regions
• Partner with priority market teams to strengthen marketing capabilities and ways of working
• Support market and global planning processes (e.g., LRFP, LRPP, business planning) through coordination and alignment
• Help provide visibility to regional priorities, tradeoffs, and dependencies
• Support governance and standards related to brand use, messaging, and market adaptation
• Support sharing of insights and learnings across key markets and platforms
• Help identify and disseminate best practices to strengthen brand impact globally

Senior Manager, Strategic Marketing

• Support execution of global brand strategy across assigned markets and initiatives
• Assist in adapting approved messaging and materials for regional relevance
• Collect and share market feedback with brand and commercial partners
• Coordinate with global brand teams and market contacts to support execution of marketing priorities
• Help local teams apply global strategies within market requirements and timelines
• Support delivery of approved marketing content, tools, and guidance to priority markets
• Help maintain consistency in brand materials, digital presence, and event execution
• Assist with capability-building efforts and sharing of effective practices across markets
• Support planning processes and help track alignment across key activities and deliverables
• Follow established brand standards and support compliant local adaptation
• Share market insights and execution learnings with internal teams
• Support identification and sharing of best practices across regions

Manager, Strategic Marketing – Biosurgery

Analyst

• Ensure early EQ involvement in application and infrastructure design/development so automated and preventive controls are built in from the start.
• Own and lead the end-to-end quality process and strategy, providing compliance guidance for applications and supporting infrastructure.
• Provide strategic direction and operational support to project teams and manage execution of TQ tasks to meet project plans, goals and timelines.
• Develop and contribute to qualification and validation strategies for new and emerging technologies.
• Maintain inspection readiness for health‑authority inspections, internal/external audits and periodic reviews; participate in audits and approve non‑conformity action plans and closures.
• Support incident management, CAPA and non‑conformance resolution for systems in scope.
• Review and approve validation work and sign off on releases to production (Compliance Plans, User Requirements/User Stories, System Tests, UAT, Traceability Matrices, Compliance Reports, etc.).
• Proactively monitor systems and processes for alignment to SOPs and industry guidelines; collaborate with the EQ Manager to manage project costs, schedules, resources and quality.
• Partner with cross‑functional team members to implement compliant solutions, set expectations, communicate feasibility/timeframes, and highlight quality risks.
• Lead and mentor people: provide quality guidance, apply risk‑based validation approaches, manage consultants/vendors, nurture future leaders and ensure resource availability for initiatives.

Senior Analyst, Digital Core

• Execute source regulatory compliance activities to ensure adherence to regulatory and quality system requirements
• Support compliance oversight for suppliers, contract manufacturers, and externally provided processes
• Partner with Supply Chain, Procurement, Quality, and Regulatory Affairs teams to support compliant supplier qualification and lifecycle management
• Interpret regulatory requirements and support translation into sourcing and supplier compliance expectations
• Support internal audits, external audits, and health authority inspections related to sourcing and supplier compliance
• Monitor compliance risks, trends, and supplier performance metrics; support corrective and preventive actions
• Ensure accurate maintenance of compliance documentation, records, and reports
• Contribute to continuous improvement initiatives to strengthen sourcing compliance governance and effectiveness

Senior Source Regulatory Compliance Specialist

• Serve as a trusted HR partner to leaders across Quality, Regulatory Affairs and Patient Safety, providing strategic and operational HR support.
• Translate business priorities into aligned people and workforce strategies.
• Partner on organizational design, workforce planning, and capability development to support evolving operating models.
• Support talent management processes including talent reviews, succession planning, and leadership development.
• Act as a coach and advisor to leaders on organizational health, engagement, and leadership effectiveness.
• Enable SC & Operations transformation initiatives through effective change leadership.
• Partner with Employee Relations, Legal, and other people related functions to address employee relations topics.
• Collaborate with HR Centers of Excellence and regional HR teams to deliver integrated HR solutions.
• Document handling: Print, stamp/seal, mail/ship, distribute, and route documents for wet signatures.
• Records management: Store/archive/retrieve HR documents; fulfill requests; coordinate offsite storage; scan and name for Veeva.
• Compliance/admin: Upload/ submit filings; print and hand-deliver to agencies; support audits and onsite audit coordination.