OneTrust

Compliance

• Lead and/or contribute to the planning, preparation (including authoring of Regulatory documents e.g. Cover Letters, Health Authority (HA) Forms, etc.) and delivery of simple and more complex submissions throughout the product’s life cycle from either a global and/or regional perspective.
• Partner with the NARL/GRL to understand the competitive landscape, e.g., views of HAs, regulatory precedents, labeling differences and therapeutic area specific issues.
• Maintain working knowledge of local regulations and submission requirements for lifecycle submissions, e.g., protocols and protocol amendments, informational amendments, annual reports, IND Safety Reports, PADERs and PSURs.
• Manage submission delivery of all application types per market and /or region.
• Serve as the Regulatory representative on specific multi-discipline teams, may be responsible for organizing and leading meetings.
• Assist in strategy development by researching regulatory and medical information in preparing submissions to regional HAs.
• Understand the regulatory framework, including regional trends, for various types of applications and procedures.
• Review and interpret related product approval information and current HA guidances and Advisory Committee meetings.
• Maintain up-to-date knowledge of regulations and industry environment and provide guidance on potential trends.
• Coordinate, contribute and review the content of responses to queries from HAs for respective/regions and countries ensuring they are of high quality and submitted in accordance with timelines.

Manager, Regulatory Scientist

Manager

• Responsible for local management of a clinical trial in a country or countries.
• Act as the primary point of contact at a country level for assigned studies.
• Operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities.
• Coordinate and lead the local trial team to deliver quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements.
• Actively contribute to process improvement; training and mentoring of Clinical Trial Assistants (CTA), Site Managers (SM), and Associate Local Trial Managers.
• May perform the role of Trial Delivery Manager (TDM)/Trial Delivery Leader (TDL) for single country.

Senior Local Trial Manager, Immunology

Director

• Lead end-to-end digital transformation and acceleration for QOps, developing strategy, plans, prioritizing initiatives, and driving delivery of specific business outcomes
• Provides leadership, strategic direction and day-to-day leadership for design, delivery, and scaling of digital solutions across QOps
• Acts as QOps’ innovation ambassador represent the team in various innovation forums
• Define and govern transformation milestones, success measures and value realization plans
• Collaborates to architect and deploy reusable platforms, components and playbooks that increase efficiency, effectiveness and user experience across the organization
• Build and scale cross-functional capability and a high-performing, diverse team

Director, Digital Acceleration

Account Manager

• Developing and executing business plans to drive utilization in existing NeuWave Medical Accounts
• Focus on recruiting new users, educating referring physicians and executing training of physicians and staff
• Managing all aspects of the customer selling lifecycle to achieve consistent, profitable and sustainable sales revenue

• Lead a diverse group of sales professionals to foster a culture of high performance, engagement and talent development
• Manage and coach team to develop and execute high impact territory business plans for leading products and win for the patients
• Continuously develop and demonstrate business, clinical and access acumen to compliantly guide the team to capitalize on opportunities in a highly competitive, dynamic environment
• Connect and collaborate with internal and external customers to identify challenges/opportunities/solutions

Senior District Manager – Immunology, Dermatology

Procurement

• Understand the JJ Technology priorities and devise category strategies that advance those priorities.
• Collaborate with business leaders and Service Delivery team to ensure Procurement strategies meet the business needs, and are adopted within the business
• Identify industry trends that Procurement must incorporate in its category strategies to ensure sustainable relevance to the business
• Partner with the Category and Service Delivery teams in the execution of strategic sourcing events, negotiations and contract lifecycle management
• Develop and maintain strong strategic relationships with key suppliers
• Deliver against savings, innovation, and other performance targets for the organization in the role’s area of responsibility and ensure target achievement

Manager, Procurement Category – IT

• Own the development and execution of strategic advanced therapies product technology roadmaps/programs and ensure strategy-to-execution discipline with the ability to translate objectives into actionable milestones and clear decision pathways to enhance product life cycles
• Lead roadmap business planning strategies in partnership with implementation teams, value chain, and manufacturing platforms across a matrix of functions to define and advance business processes.
• Lead global, multi-site, and cross-functional team members in the strategic implementation of high-value solutions required to achieve commitments in new technology, science, facilities, processes, and products.
• Support MSAT portfolio governance & analytics; managing portfolio health, visibility, and communication such as ROI, benefits realization, risk, and readiness with executive leadership, finance, and other key stakeholders.
• Ensure technical and manufacturing requirements are addressed throughout the lifecycle of new solutions and drive continuous improvements.
• Foster an operational excellence culture among teams to enhance productivity and efficiency of operations.
• Proactively align decision making with enterprise-wide strategy, evaluating short- and long-term goals against potential consequences and benefits/risks analyses.
• Devise strategies and solutions to deliver rapid growth ambitions including enhancing reliability, compliance, efficiency of product value chains end-to-end including product life cycle management.
• Maintain a robust technical support network related to lifecycle management, new technologies, automation, comparability, change management, and technology transfers for products, including material science assessments, sourcing strategies, and critical to quality processes.
• Continuously analyze network performance and produce concepts which support COGM reduction, robustness, and efficiency.

Director, Strategic Programs – Portfolio MSAT Advanced Therapies

Financial Planning and Analysis

• Serve as primary Finance business partner for the global EP & NV Procurement and Supply Chain teams to analyze financial data and influence business decisions
• Independently lead key month-end close and forecasting processes, including building content for and presenting to EP & NV Supply Chain leadership teams
• Forecast, track, and analyze purchase price variances, including but not limited to cost improvement projects, market-driven price increases, and other raw material surcharges.
• Maintain balance sheet reconciliations for annual accruals, as well as consigned inventory based on timing of receipts
• Partner with EP & NV PMO to proactively track and validate business cases behind cost savings (for both existing products and upcoming new product launches), operational expenses, and capital expenditures
• Proactively look for opportunities to streamline and automate processes, including acting as a change agent during the CFIN/Anaplan go-lives for MTSC
• Ensure compliance is kept at the forefront with respect to both general accounting and J&J Procurement policies & procedures
• Facilitate annual standard cost setting with business partners
• Support ad hoc business needs in a sophisticated, matrixed environment