OneTrust

Risk

• The Sr. Manager, Clinical Quality Risk Management Lead for Surgery advances the Clinical Quality Risk Management (CQRM) objective, overseeing a robust GxP Quality Management System.
• Oversees the overall clinical quality risk management of the Surgery MedTech Business.
• Works across teams to ensure the coordination of the identification, assessment, and mitigation of clinical quality risks that could have an impact on trial data integrity, patient rights, safety, or well-being.
• Oversees the execution of data-driven, risk-based trial and program oversight activities that deliver quality in the execution of clinical trial programs, compliance with regulatory requirements and internal procedures, and that there is a continued state of inspection readiness.
• Develops and ensures a consistent interpretation of issues that require quality investigations.
• Provides guidance for significant quality issues per corporate standards and escalates SQI to senior R&D and Quality & Compliance management.

Senior Manager, Clinical Quality Risk Management

Data Scientist

• Shape the strategy and implement projects for data-driven identification of novel therapeutic targets, patient stratification approaches and precision biomarkers from the perspective of omics data
• Work in multi-disciplinary teams, composed of discovery scientists, clinicians, computational biologists and biomarker experts to develop precision neuroscience plans
• Remain current on the evolving landscape of neuroscience, neuropsychiatry, and neurodegeneration
• Build strong relationships with internal partners and key academic collaborators, technology providers, and consortia

Principal Scientist, Omics – R&D Data Science, Digital Health – Neuroscience

• Implement innovative data science projects to uncover novel therapeutic targets, optimize patient stratification, and identify precision biomarkers by deriving insights from multi-omics data linked to brain biology and neuropsychiatric/neurodegenerative disease mechanisms
• Work in multi-disciplinary teams, composed of discovery scientists, clinicians, computational biologists and biomarker experts to support the precision neuroscience strategy for programs in the Neuropsychiatry/Neurodegeneration portfolio
• Remain current on the constantly evolving landscape of neuroscience, neurodegeneration, and neuropsychiatry, omics, bioinformatics and AI/ML research in search of better approaches for accelerating and prioritizing our portfolio based on biological insights.
• Build strong relationships with internal partners and key academic collaborators, and consortia to position the company at the forefront of data-driven neuroscience.

Senior Scientist, Omics – R&D Data Science, Digital Health – Neuroscience

Full-stack Engineer

• Lead multidisciplinary project teams in the design, development, testing, and manufacturing of wound closure devices, related products, and other novel medical devices, and be able to function as a team member as required.
• Play a hands-on role in conducting lab-based development activities, analyze and interpret performance and analytical data to guide product and process optimization, document research activities in accordance with design control requirements, and conduct all required research activities associated with development of new materials, components, raw materials, and processes for wound closure devices.
• Effectively apply state-of-the-art scientific technical acumen and technical leadership capabilities to conduct research toward design of new products, as well as supporting and improving (lifecycle management of) existing product offerings.
• Provide technical expertise, in terms of problem solving for technical and executional problems using advanced knowledge and experience.
• Contribute inventions, new designs, new processes, and techniques to solve technical problems based on customer needs.
• Identify opportunities for design and process improvements to achieve business goals.
• Ensure project timelines and all required project milestones are met.
• Conducts or manages research, analysis or processes within a larger R&D activity.
• May develop procedures and processes within broader protocols.
• May develop and implement standards for reporting and operations.
• May identity and implement process level efficiencies.
• Conduct research toward new product or process development or improvement of existing products or processes.
• Interact directly with customers (surgeons) to determine and identify unmet needs.
• Contribute inventions, new designs, new processes and techniques to solve technical problems based on customer needs.
• Uses analytical/technical expertise to contribute to product development/testing.
• Ensures that project guidelines are followed, and processes are complete.
• Executes DOE’s and tests materials per protocols.
• Prepare samples as required for manufacturing, testing, or other evaluations and data analysis.
• Writes SOP’s, JSA’s (Safety) and other required documentation.
• Maintenance of notebooks and batch records in compliance with GLP/GMP
• Participate in process and product transfer to operations group
• May coordinate with outside vendors and academia
• Ensures activities are completed on time and comply with industry standards and regulatory requirements.
• Follows all company guidelines related to Health, Safety and Environmental practices .
• May supervise or provide instruction to professional and technical employees.
• May be responsible for operating within a budget and may provide input on budget allocation and prioritization.
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• Responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Performs other duties assigned as needed.

Senior Engineer, Intra-Company Collaborations – MedTech Surgery

Sales

• Apply adult learning principles and a story-based approach to training initiatives including the creation, implementation, and evaluation of training programs.
• Training responsibilities may include: Launch readiness and launch pull-through.
• Developing a competitive selling curriculum that can be leveraged for both new hires and the ongoing development of the existing sales team.
• Share in the responsibilities of POA workshop development, new hire training, selling skill curriculums, and other training responsibilities.
• Deliver both in-person and virtual training in a way that inspires participants to apply the principles discussed.
• Design engaging and effective training materials, including presentations, manuals, e-learning modules, and assessments.
• Lead and manage the full lifecycle of assigned training projects including planning, resource allocation, execution, and delivery.
• Develop and maintain project timelines, and communication plans to ensure meeting delivery deadlines and collaborate with marketing, medical, regulatory, and leadership to ensure alignment across departments.
• Manage Learning Management System content from a training perspective for both new hires and existing representatives.
• Assist in the implementation of training needs assessments and the identification of training initiatives to address any gaps or opportunities.
• Create, implement, and facilitate training tailored to the principles of compliance for all sales forces.
• Review and update all compliance training as needed.
• Collaborate with the compliance and market access teams to identify future training needs and develop proactive plans to address these needs.

Manager, Sales Training

Manager

• Lead a global team of Technical Launch Integrators (TLIs) and Technical Owners (TOs)
• Enable collaboration with R&D to optimize the design of devices and primary containers
• Drive development, implementation, and validation of device assembly and primary packaging processes
• Support device assembly and packaging sourcing decisions
• Enable collaboration with Engineering to ensure equipment is accurately designed
• Support technical transfers and manufacturing process capacity scale-up

Senior Manager, Device & Primary – Synthetics, TARIS

Business Operations

• Serve as PQM process owner for selected QMS processes, including Internal Audits.
• Provide back-up support for other systems such as NC/CAPA, Change Control, Document Management, and Training.
• Assume additional ownership of tactical support systems over time (e.g., COMET STAR user), ensuring compliance, system access, and oversight.
• Actively participate in councils and forums related to QMS processes.
• Continuously improve processes and systems to enhance efficiency and effectiveness.
• Support Quality Review Meetings, metrics, and dashboards for PQM and TDS.
• Provide budget support for PQM, including headcount oversight, LRFP, and BP planning (currently for PQM-base and ECSQ), in alignment with other team members.
• Support onboarding and training of new team members as well as document management and training activities to maintain PQM’s operational continuity.

Senior Analyst, Business Process Quality

• Create and update critical trial-specific documents (e.g., Monitoring Guidelines, Informed Consent Form, Investigational Medicinal Product [IMP] related documentation).
• Manage vendor set up and management of day-to-day study vendor activities, including set-up, SOW creation and budget oversight.
• Responsible for country / regional coordination of trial management activities and oversight (e.g., aligns feasibility strategy with local teams, perform country-level risk reviews, aware of all projects conducted across countries).
• Support development of program-level compound training, collaborating with Clinical / CTL&T / Medical writing.
• Provide input into trial level operational strategies.
• Resolve trial-related issues and mitigate trial-related risks.
• Participate in process improvement activities at a trial, compound & cross-DU level, as needed.
• Provide support during Health Authority inspections and on the identification of risks and mitigation plans at the program level for key issues.
• Mentor & support onboarding of new team members, particularly those in Trial Management.

Lead Trial Delivery Manager – Oncology

Account Executive

• Expand the sales of Ethicon US, LLC products
• Support to the aligned Area for all sales-related activities
• Execute the selling cycle in a concise, professional, and ethical manner
• Conduct business in accordance with company policy

Associate Account Executive

• Devise and implement customer specific pre and post call selling approaches that evaluate and address the practitioners’ perspectives and the institutions philosophies within compliance guidelines.
• Consistently use approved clinical studies and marketing aids to support the case for the value proposition when selling.
• Position and adapt the message to meet the practitioner’s, institutions, and company’s objectives.
• Develop and execute on comprehensive business plan that includes but not limited to opportunities and challenges in local market, key strategies and tactics to drive the business, maximization of resources available as well partnership with key business partners and stakeholders in order to drive sales in local geography.
• Develop a territory coverage plan that maximizes selling time with all account professionals.
• Adjust the schedule to increase access to key stakeholders, including coverage of all shifts.
• Institute strategies to increase access to all key stakeholders.
• Maximize and customize the value proposition and influence contract implementation processes within the assigned institutions.
• Hold hospital stakeholders accountable to the institutional contract.
• Develop and apply knowledge of payer access and affordability landscape in the territory regarding the company’s products.
• Devise and institute an integrated business plan that includes clear strategies and tactics to target key accounts utilizing all available resources, while aligning the plan with the district’s, regions, and company’s goals.
• Analyze business analytics to recognize territory opportunities, strengths, and trends, and to monitor the effectiveness of the business plan.
• Adjust the plan to minimize the impact of competition and to maximize sales opportunities.

Senior Neuroscience Sales Specialist

Compliance

• Lead and coordinate scientific research support for GRA and GRPI policy positions and initiatives.
• Oversee the regulatory intelligence function, ensuring timely and relevant insights.
• Conduct or coordinate research for various outputs including publications, presentations, and policy positions.
• Support the policy team’s coverage of trade association policy activities and other external policy groups.
• Create and implement tools and strategies to develop and align policy priorities, strategic plans, and other policy documents.
• Manage GRPI efforts related to commenting programs, developing and submitting company perspectives.
• Support the Head GRPI with functional governance activities including strategy and goal setting.
• Oversee the GRPI website and related tools.
• Provide project management, process, and change leadership for GRPI-driven initiatives.
• Supervise a small team responsible for regulatory intelligence, communications, and operational support for GRPI.
• Work with cross-functional leaders and partners to advance policy initiatives.

Director, Regulatory Policy Research and Operations

• Recruiting, leading, coaching, developing and managing high caliber Sales executives.
• Review and manage portfolio relative to market demand and allocate resources according to greatest opportunities for growth.
• Deliver on both top line and regional profitability targets as established in the business plan.
• Define and execute long-term business growth strategy that drives increased sales, market share, and/or market growth opportunities.
• Gain market insights through interaction with customers, consumers, payors, regulators and industry experts; develop a deep understanding of problems, needs, and translate into possible solutions.
• Apply financial and commercial acumen to analyse and report sales results against forecast to senior management and make any adjustments to business plans to ensure objectives are met.
• Utilize strong negotiation skills to establish, maintain and grow partnerships with customers and stakeholders.
• Collaborate with marketing teams, health care compliance and Business Development to develop and execute strategic plans for Vision including but not limited to pricing decisions.
• Actively participates on the Vision Surgical Canada Leadership Team and leads team meetings, and year end activities.
• Monitor business progress, identify key learnings and initiate indicated actions as necessary.

Regional Business Manager

Software Engineer

• Develop and maintain a macro library in collaboration with Manager of statistical programming
• Work within company processes and procedures for statistical programming
• Provide oversight of the quality review of all programming deliverables
• Work with Biostatistics, Clinical, and Medical Research partners to develop plans for timely delivery of reports, metrics and study deliverables
• Design, implement and maintain complex programming deliverables across a wide variety of data sources for company products

Lead Statistical Programmer

Account Manager

• Represent the organization by interacting with established customers and developing new prospects in order to sell the organization's ACUVUE® Brand Contact Lenses.
• Apply a broad knowledge of the organization's products, services and marketing campaigns to close sales and maintain relations with specifically identified customers.
• Uncover and understand customer’s strategic priorities, buying motives, end user needs, office processes, and business operations across segments while demonstrating the ability to gain an order or product commitment.
• Be responsible for learning the organization's products, services and policies in preparation for selling.
• Demonstrate the following: Knowledge of organization's products and services and possesses the ability to articulate added value in a dialogue with the customer while securing orders, assists in inventory/dx lenses control, keeps customers abreast of supply and price trends, and maintains records and reports of all phases of activities.
• Scientific and economic product differentiation to customers in a compliant manner while maintaining sales program within assigned territory.
• Understand customer’s business and segment in order to position products and economic solutions as the best option for the customer and their patients, while delivering a competitive clinical and financial message tailored to meet the customer’s unique need.
• Effectively communicate and utilize multiple resources and tools to deliver a clear and concise sales message and will complete and execute pre-call plans for all accounts that consistently changes behavior among customers.

Territory Account Manager

• Identify and prioritize high-impact customer groups to optimize marketing efforts and resource allocation.
• Use insights from market research, data analysis and field input to anticipate customer needs and adapt strategies accordingly.
• Develop clear, differentiated, and compelling value propositions for key customer segments, emphasizing product benefits, clinical outcomes, and cost-effectiveness.
• Customize messaging and solutions to address the unique challenges and goals of specific accounts and customer personas.
• Work closely with US Marketing, HEMA and the Key Account team to ensure the value proposition aligns with product capabilities and market needs.
• Design and implement strategic marketing plans tailored to key accounts, focusing on delivering measurable business growth.
• Integrate multi-channel marketing approaches, including digital campaigns, educational events, and thought leadership initiatives.
• Align marketing plans with sales goals, product launches, and organizational objectives.
• Build and launch marketing tools and resources, such as customized presentations, case studies, QBRs and ROI analyses to support the Key Account field team.
• Identify market research needs to understand industry trends, competitor activities, and customer dynamics.
• Use market & competitive intelligence to refine segmentation strategies, improve marketing plans, and identify growth opportunities.
• Identify and engage with critical professional societies (eg ACHE, Becker’s), and evaluate which societies to prioritize for in-person meetings and other engagements.
• Establish KPIs to track the success of marketing plans, including customer acquisition, retention, and account growth.