Vertex Inc.
Remote Jobs
Vertex is a global biotechnology company that invests in scientific innovation.
100 Jobs
Principal Statistical Programmer
Vertex Inc.Vertex is a global biotechnology company that invests in scientific innovation.
Role Description The Principal Statistical Programmer works with management to delegate tasks appropriately, track progress, and provide expert technical support to team members. In addition, the Principal Statistical Programmer is a designated member of clinical sub-team(s) in the role of project lead Statistical Programmer. Key Duties and Responsibilities: - Works regularly with advanced features of SAS (including interfacing ability with other software applications and operating system tools). - Performs quality control checks of SAS code and output produced by other Statistical Programmers to ensure accuracy and consistency within group. - Demonstrates in-depth knowledge of clinical development and medical data. - Solves complex clinical trial reporting problems and demonstrates technical proficiency and exercises judgment in supporting daily operations and ensuring that study tasks are completed accurately and in a timely manner. - Engages with a variety of other functions, including Statistical Programmers, Biostatisticians, Data Management, and other departments engaged in providing data and submission-related activities, often at Senior Management levels. - Creates all files, documents, and analyses necessary to support an electronic submission in eCTD format, including ISS/ISE. - Provides leadership to ensure compliance with Vertex SOP'S and FDA/ICH/GCP regulations. - Provides technical and project management skills to create, review, and approve documentation required to support data analysis, reporting, and CDISC data submission. - Participates in project management cross-functional teams that work on standard operating procedures, guidelines, process improvements, system validation and acquisition, customization, and integration of new tools and technologies. Qualifications - Proficiency in all SAS language, procedures, and functions commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH. - Intermediate knowledge of CDISC Standards. - Intermediate knowledge of clinical trials. - Regulatory submission experiences. - Effective communication (written and verbal) skills to explain difficult information. Requirements - Bachelors degree in a Scientific Discipline. - Typically requires 5+ years for M.S. or above and 8+ years for B.S. years of work experience in Biotech, Pharmaceuticals or Clinical Research Organization. Benefits - Annual bonus and annual equity awards. - Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. - Inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey. - Medical, dental and vision benefits. - Generous paid time off (including a week-long company shutdown in the Summer and the Winter). - Educational assistance programs including student loan repayment. - Generous commuting subsidy. - Matching charitable donations. - 401(k) and so much more. Flex Designation Remote-Eligible Flex Eligibility Status In this Remote-Eligible role, you can choose to be designated as: - Remote: work remotely five days per week and come into the office on occasion – you’re always welcome on-site; - Hybrid: work remotely up to two days per week; - On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.
International PV Manager
Vertex Inc.Vertex is a global biotechnology company that invests in scientific innovation.
Role Description The International Pharmacovigilance (PV) Manager is a member of the Global Patient Safety (GPS) International Pharmacovigilance Team responsible for leading and maintaining compliance with PV regulations for Vertex products throughout the region. This role operates with a high degree of independence and accountability, applies regional regulatory knowledge to practical execution, makes recommendations and day-to-day decisions within defined PV compliance responsibilities, and escalates material risks appropriately to International PV leadership. This individual ensures that work performed within the role’s scope is in accordance with relevant regulatory guidelines. This role is strictly non-promotional and operates in alignment with the principles of pharmacovigilance. Qualifications - Saudi passport - Ability to multi-task with sound attention to detail - Excellent written and oral communication skills in English and Arabic - Strong sense of responsibility and an ability to work autonomously, as well as in a team setting - Understands established procedures and communicates those procedures to others - Ability to adapt and react to change in priorities and effectively manage workload - Owns assigned regional PV compliance deliverables and supports regulatory inspection and internal/external audit activities when requested - Maintains current understanding of PV regulatory requirements and applies that knowledge to guide compliant regional execution - Provides oversight of delegated and outsourced PV activities within assigned regional responsibilities - Ability to apply knowledge to new situations Requirements - Accountable for ensuring that assigned territory PV activities and GPS procedures are aligned with applicable global and local PV regulations - Leads coordination and finalization of required GPS contractual agreements to support local and regional PV regulatory obligations - Maintains working knowledge of evolving PV expectations in the region - Responsible for assessment of PV regulatory intelligence impacting the region and determines appropriate escalation, implementation, or stakeholder engagement actions within defined authority - Evaluates effectiveness of the Quality Management System for assigned regional activities and recommends improvements, including localization where needed - Reviews and may be responsible for authoring Standard Operating Procedures (SOPs) and Work Instructions (WIs) with minimal supervision - Maintains and is accountable for required PV documentation, including PSMF sections, annexes, role descriptions, and training records - Provides GPS oversight of PV activities performed by staff, vendors, and partners, including monitoring performance, identifying risks, and driving timely follow-up - Reviews PV metrics, compliance reports, and issue logs; escalates deviations, risks, or delays - Leads or actively contributes to vendor/partner meetings related to PV execution, issue resolution, and compliance oversight - Supports readiness for health authority inspections and internal audits for assigned regional PV activities, including coordination of responses and corrective actions as appropriate (may support onsite PV inspections) - Leads build out and maintenance of Vertex’s PV system in assigned new markets - Represents GPS regarding patient safety related matters as assigned - Represent Vertex GPS as appointed Local Responsible Person for Pharmacovigilance (RPPV) or Qualified Person for Pharmacovigilance (QPPV), or deputy, as assigned - Exercises defined decision-making authority for assigned regional PV compliance and oversight matters, including determining when issues can be resolved locally and when escalation to International PV leadership is required - Performs other duties as assigned. Benefits - Flex Designation: Remote-Eligible - Flex Eligibility Status: In this Remote-Eligible role, you can choose to be designated as: - Remote: work remotely five days per week and come into the office on occasion – you’re always welcome on-site; - Hybrid: work remotely up to two days per week; - On-Site: work five days per week on-site with ad hoc flexibility. - Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. Company Description Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Account Executive Principle
Vertex Inc.Vertex is a global biotechnology company that invests in scientific innovation.
Role Description This role is responsible for generating new revenue through the sale of Vertex transaction tax solutions across a defined territory. The successful candidate will combine enterprise SaaS sales experience, strong pipeline generation capability, and value-based selling to open new logos, build strategic customer relationships, and close complex software opportunities across Tax, Finance, IT, Procurement, and C-suite stakeholders. - Generate new revenue by selling Vertex transaction tax solutions to prospects and customers within a defined territory. - Develop and execute GTM plans, territory strategies, account plans, outbound campaigns, and pipeline generation activity to create demand and open new logos. - Manage the full new business sales cycle from prospecting and qualification through negotiation, forecasting, objection handling, and close. - Navigate complex stakeholder environments, engaging senior decision-makers across Finance, Tax, IT, Procurement, and C-suite audiences. - Use a commercial, value-based selling approach to uncover customer pain points, build compelling business cases, and position Vertex solutions against measurable business outcomes. - Build trusted relationships with prospects, customers, partners, and internal stakeholders to support strategic account development and long-term revenue growth. - Maintain strong market knowledge across enterprise SaaS, tax technology, transaction tax, VAT/sales tax, ERP, compliance, and adjacent software markets. Qualifications - Proven enterprise SaaS sales experience selling complex software solutions, ideally within tax, finance, ERP, compliance, or transformation-led environments. - Hunter mentality with demonstrated success self-generating pipeline, prospecting, creating demand, opening new logos, and consistently attaining quota. - Strong GTM execution capability, including territory planning, account strategy, outbound campaigns, and pipeline generation. - Excellent executive-level communication, presentation, negotiation, closing, forecasting, and objection-handling skills. - Strong knowledge of the software and tax industries. - Strategic relationship-building skills, with the ability to establish credibility quickly with senior stakeholders, prospects, customers, partners, and internal teams. - Commercial and value-based selling mindset, with the ability to identify customer pain points and link solutions to measurable outcomes. - Results-driven, resilient, and accountable, with a strong sense of urgency and consistent delivery against revenue goals. - Strong knowledge of enterprise software, tax technology, transaction tax, VAT/sales tax, or adjacent compliance software markets. Requirements - Bachelor’s degree in Business, Marketing or demonstrable work experience in enterprise SaaS, software, or transaction tax sales required. - Experience selling to mid- and senior-level decision-makers across Finance, Tax, IT, Procurement, and executive audiences required. - Strong working knowledge of Vertex or comparable transaction tax, ERP, finance, or compliance software highly desirable. - Demonstrated success managing complex full-cycle sales opportunities from prospecting through close required. Benefits - Annual Salary Range: kr818,100.00 - kr1,063,600.00 - Pay Basis: Monthly - Participation in the Vertex Bonus Plan (VOB), a role-specific sales commission or bonus, and/or equity grants, where applicable.
Account Executive Principal
Vertex Inc.Vertex is a global biotechnology company that invests in scientific innovation.
Role Description This role is responsible for generating new revenue through the sale of Vertex transaction tax solutions across Benelux. The successful candidate will combine enterprise SaaS sales experience, strong pipeline generation capability, and value-based selling to open new logos, build strategic customer relationships, and close complex software opportunities across Tax, Finance, IT, Procurement, and C-suite stakeholders. - Generate new revenue by selling Vertex transaction tax solutions to prospects and customers within a defined territory. - Develop and execute GTM plans, territory strategies, account plans, outbound campaigns, and pipeline generation activity to create demand and open new logos. - Manage the full new business sales cycle from prospecting and qualification through negotiation, forecasting, objection handling, and close. - Navigate complex stakeholder environments, engaging senior decision-makers across Finance, Tax, IT, Procurement, and C-suite audiences. - Use a commercial, value-based selling approach to uncover customer pain points, build compelling business cases, and position Vertex solutions against measurable business outcomes. - Build trusted relationships with prospects, customers, partners, and internal stakeholders to support strategic account development and long-term revenue growth. - Maintain strong market knowledge across enterprise SaaS, tax technology, transaction tax, VAT/sales tax, ERP, compliance, and adjacent software markets. Qualifications - Proven enterprise SaaS sales experience selling complex software solutions, ideally within tax, finance, ERP, compliance, or transformation-led environments. - Hunter mentality with demonstrated success self-generating pipeline, prospecting, creating demand, opening new logos, and consistently attaining quota. - Strong GTM execution capability, including territory planning, account strategy, outbound campaigns, and pipeline generation. - Excellent executive-level communication, presentation, negotiation, closing, forecasting, and objection-handling skills. - Strong knowledge of the software and tax industries. - Strategic relationship-building skills, with the ability to establish credibility quickly with senior stakeholders, prospects, customers, partners, and internal teams. - Commercial and value-based selling mindset, with the ability to identify customer pain points and link solutions to measurable outcomes. - Results-driven, resilient, and accountable, with a strong sense of urgency and consistent delivery against revenue goals. - Strong knowledge of enterprise software, tax technology, transaction tax, VAT/sales tax, or adjacent compliance software markets. Requirements - Bachelor’s degree in Business, Marketing or demonstrable work experience in enterprise SaaS, software, or transaction tax sales required. - Experience selling to mid- and senior-level decision-makers across Finance, Tax, IT, Procurement, and executive audiences required. - Strong working knowledge of Vertex or comparable transaction tax, ERP, finance, or compliance software highly desirable. - Demonstrated success managing complex full-cycle sales opportunities from prospecting through close required. Benefits - Annual Salary Range: €107,400.00 - €139,700.00 - Pay Basis: Monthly - Participation in the Vertex Bonus Plan (VOB), a role-specific sales commission or bonus, and/or equity grants, where applicable. - Compensation growth over time through performance-based increases, expanded responsibilities, role progression, or internal career opportunities.
Security Program Manager
Vertex Inc.Vertex is a global biotechnology company that invests in scientific innovation.
Role Description We're hiring a Security Program Manager to serve as the operating backbone of the Office of the CISO. This is a senior individual contributor role for someone who thrives on connecting people, programs, and priorities across a complex enterprise and who uses AI tooling deliberately to multiply their impact. You'll partner directly with the CISO across all pillars of our security organization to drive security initiatives, OKRs, KPIs, and metrics into a single, coherent operating system. This is not a traditional project manager role. You'll own the full lifecycle of security programs—from intake and prioritization through execution and long-term operational health—and you'll succeed through influence, structure, and clarity rather than direct authority. You'll have a direct line to the CISO and immediate visibility across the enterprise. You'll shape how security operates, how it reports, and how it scales, including how the company governs AI as adoption accelerates. If you want to do the highest-leverage program management work of your career in security, this is it. - Run the Security Operating System - Own the operating cadence of the CISO function — weekly staff meetings, monthly program reviews, and quarterly business reviews. - Produce the recurring decision-grade CISO report (executive summary, OKR scorecard, KPI scorecard, portfolio milestones, decisions required). - Maintain a single portfolio view across all security programs — intake, approved, executing, complete — with clear stage gates, owners, and forecasts. - Drive meeting preparation, documentation, stakeholder communication, and follow-through so leadership can focus on judgment calls, not coordination. - Own the OKR, KPI, and Metrics System - Run the quarterly OKR lifecycle across all four security teams — define, align, health check, and score. Ensure every Key Result has a baseline, target, owner, measurement method, and confidence level. - Maintain a KPI dictionary with definitions, formulas, systems of record, thresholds, and cadence — covering posture KPIs, program delivery KPIs, and team execution KPIs. - Ensure 100% of project work is mapped to an OKR or documented as run the business. - Lead monthly trend analysis and tie outcomes back to security and business objectives. - Drive Cross-Functional Program Delivery - Own end-to-end delivery of security programs — risk management, vulnerability management, security awareness, product onboarding into security, M&A security execution, incident readiness, and compliance initiatives. - Act as the primary liaison between Security and Engineering, IT, Product, Legal, Privacy, Finance, People, Sales, and Customer Success. - Manage cross-team dependencies, and decision logs as drivers of action. - Enforce escalation SLAs and stage gates with a small, senior, expert team. - Build Executive & Board Communications - Build recurring deliverables for executive leadership, audit committee, and board updates — executive summaries, slide content, speaker notes, and Q&A prep. - Translate technical security and AI governance topics for non-technical executive audiences with clarity and brevity. - Produce decision-grade options memos with root cause, tradeoffs, recommendation, owner, and deadline. - Multiply Output Through Deliberate AI Use - Use AI tooling (e.g., Microsoft 365 Copilot, Claude, ServiceNow AI) deliberately and daily — for status synthesis, dashboard refresh, meeting recaps, draft communications, evidence collection, and audit response prep. - Identify and execute automation opportunities across security operations, GRC, and compliance workflows. Qualifications - 7+ years of progressive program or portfolio management experience, with 4+ years dedicated to information security, GRC, or product security programs in a SaaS or cloud environment. - Proven track record running OKR/KPI operating systems for security or technology leaders, including executive-ready reporting. - Direct experience coordinating across GRC, Product/Application Security, Security Operations/Incident Response, and emerging AI security and governance functions. - Demonstrated ability to operate as connective tissue across Engineering, Legal, Product, IT, Finance, and Sales — leading through influence rather than authority. - Mastery of program management tooling — Jira, Confluence, ServiceNow, Smartsheet, PowerPoint, Excel/Power BI. - Strong executive written and verbal communication; ability to produce concise, structured, dashboard-style one-pagers and decision memos. - Comfortable enforcing operating discipline (cadences, stage gates, escalation SLAs) in a small, senior, expert team. - Bias for action, ownership, and outcome — not activity. AI Literacy - Hands-on, deliberate daily use of AI tooling in your own workflows (drafting, synthesis, dashboards, evidence preparation, meeting recaps). - Understanding of AI security concerns: model risk, data leakage, prompt injection, third-party AI vendor risk, Shadow AI, AI guardrails, and Responsible AI principles. Preferred Certifications - PMP, PgMP, or equivalent program management certification. - CISSP, CISM, CRISC, or CISA (one strongly preferred). - AI Governance certification (e.g., IAPP AIGP, ISO 42001 Lead Implementer). Other Qualifications - The Winning Way behaviors that all Vertex employees need in order to meet the expectations of each other, our customers, and our partners. - Communicate with Clarity - Be clear, concise and actionable. Be relentlessly constructive. Seek and provide meaningful feedback. - Act with Urgency - Adopt an agile mentality - frequent iterations, improved speed, resilience. 80/20 rule – better is the enemy of done. Don’t spend hours when minutes are enough. - Work with Purpose - Exhibit a “We Can” mindset. Results outweigh effort. Everyone understands how their role contributes. Set aside personal objectives for team results. - Drive to Decision - Cut the swirl with defined deadlines and decision points. Be clear on individual accountability and decision authority. Guided by a commitment to and accountability for customer outcomes. - Own the Outcome - Defined milestones, commitments and intended results. Assess your work in context, if you’re unsure, ask. Demonstrate unwavering support for decisions. Pay Transparency Statement US Base Salary Range: $114,500.00 - $148,800.00. Base pay offered to new hires may vary based upon factors including relevant industry and job-related skills and experience, geographic location, and business needs. The range displayed does not encompass the full potential of the role, which allows for further growth and career progression. In addition, as a part of our total compensation package, this role may be eligible for the Vertex Bonus Plan (VOB), a role-specific sales commission/bonus, and/or equity grants. Learn more about Life at Vertex and connect with your recruiter for more details regarding Vertex's compensation and benefit programs. In no case will your pay fall below applicable local minimum wage requirements.
Senior Principal Technical Program Manager
Vertex Inc.Vertex is a global biotechnology company that invests in scientific innovation.
Role Description We are seeking a Senior Principal Technical Program Manager to lead one of Vertex's most strategic transformation programs: the Connected Tax Platform Experience (CTPE). This is not a traditional delivery coordination role. CTPE connects AI-driven tax workflows, shared platform capabilities, governance and trust controls, customer-facing experiences, and measurable business outcomes into a unified platform experience. As a Senior Principal TPM, you will serve as a system-level execution leader responsible for translating strategy into scalable execution across Product, Engineering, Architecture, Platform, UX, Data, Governance, and Operations. You will create clarity in ambiguous environments, align stakeholders around shared outcomes, surface risks before they become blockers, and provide leadership with trusted visibility into program health, readiness, and delivery confidence. Success in this role requires strong technical fluency, systems thinking, executive communication skills, and the ability to drive alignment across multiple organizations with competing priorities. You will help connect product intent to engineering execution, execution to release readiness, and release readiness to customer and business outcomes. This role offers the opportunity to influence one of Vertex's highest-priority strategic initiatives and help shape the future of Technical Program Management through AI-augmented workflows, signal-driven execution, modern governance practices, and outcome-focused delivery. Key Responsibilities - Lead large-scale, cross-functional technical programs that span Product, Engineering, Platform, Architecture, UX, Data, Governance, and Operations. - Translate business strategy and product vision into structured execution plans, milestones, dependencies, risks, decision frameworks, and measurable outcomes. - Establish and maintain program operating mechanisms including roadmap management, dependency tracking, risk management, executive reporting, and release planning. - Create clarity in ambiguous and rapidly evolving environments by identifying tradeoffs, structuring work, defining priorities, and enabling informed decisions. - Drive alignment across multiple products, platforms, and workflow domains to achieve shared business and customer objectives. - Partner with Product, Engineering, and Architecture leaders to connect roadmap priorities, technical dependencies, release readiness, and customer value realization. - Establish governance practices using metrics, telemetry, readiness indicators, risk thresholds, and outcome-based measurements. - Proactively identify execution risks, dependency gaps, governance concerns, and delivery bottlenecks while driving mitigation and escalation when necessary. - Lead executive-level communications that provide clear visibility into progress, risks, confidence levels, tradeoffs, and business impact. - Leverage AI-assisted workflows, automation, and scalable operating mechanisms to improve execution velocity, transparency, and delivery quality. - Ensure customer-facing platform capabilities are delivered with appropriate technical, operational, and organizational readiness. - Help evolve TPM practices that improve execution quality, visibility, and decision-making across complex enterprise programs. Qualifications - 10+ years of experience leading large-scale technical programs within SaaS, cloud, platform, or enterprise software organizations. - Proven success leading complex cross-functional initiatives involving multiple products, engineering organizations, platform teams, and executive stakeholders. - Demonstrated ability to translate strategy into scalable execution through governance, planning, dependency management, risk mitigation, and measurable outcomes. - Strong systems-thinking skills with the ability to connect strategy, technical execution, architecture, customer experience, and business impact. - Experience partnering with Engineering and Architecture leaders to evaluate technical tradeoffs, platform dependencies, scalability considerations, and delivery sequencing. - Strong technical acumen across cloud platforms, enterprise software, data platforms, distributed systems, workflow platforms, or AI-enabled products. - Experience managing complex dependencies, risks, governance requirements, and executive decision points. - Executive-level communication skills with the ability to create trusted narratives, decision frameworks, risk assessments, and outcome-based reporting. - Demonstrated ability to influence senior leaders and drive alignment without relying solely on formal authority. - Ability to operate effectively in ambiguity, create clarity without complete requirements, and drive progress across competing priorities. - Experience delivering customer-facing product or platform capabilities through release, adoption, and operational readiness. - Bachelor's degree in a technical, business, or related field, or equivalent practical experience. Preferred Qualifications - Experience leading AI-first, automation, workflow transformation, data platform, or platform modernization initiatives. - Experience within tax, compliance, fintech, ERP, e-invoicing, audit, or other regulated software environments. - Experience delivering customer-facing platform experiences that span multiple products and shared technical foundations. - Experience defining program metrics, release confidence frameworks, readiness models, governance mechanisms, or signal-driven operating structures. - Experience using AI tools, automation, knowledge management, or workflow orchestration technologies to enhance execution effectiveness. - Experience partnering with executive leadership on enterprise transformation programs or portfolio-scale initiatives. - Experience coaching TPMs or developing scalable TPM operating models. - Familiarity with Agile, Lean, SAFe, or similar delivery methodologies and the ability to apply them pragmatically. - PMP, PgMP, cloud, AI, data, or related technical certifications are a plus. Pay Transparency Statement US Base Salary Range: $191,500.00 - $249,000.00. Base pay offered to new hires may vary based upon factors including relevant industry and job-related skills and experience, geographic location, and business needs. The range displayed does not encompass the full potential of the role, which allows for further growth and career progression. In addition, as a part of our total compensation package, this role may be eligible for the Vertex Bonus Plan (VOB), a role-specific sales commission/bonus, and/or equity grants. Learn more about Life at Vertex and connect with your recruiter for more details regarding Vertex's compensation and benefit programs. In no case will your pay fall below applicable local minimum wage requirements.
Director, Regulatory Labeling Strategy
Vertex Inc.Vertex is a global biotechnology company that invests in scientific innovation.
Role Description The Regulatory Labeling Director will lead the strategic development of global labeling on one or more marketed products. This role will be responsible for the development and maintenance of global product labeling across a therapeutic area. This will include: - Target labeling profiles (TLP) - Company core datasheets (CCDS) - Local labeling (prescribing information, patient information) for major markets This role will be accountable for specific labeling business processes. Key Duties and Responsibilities - Ensures compliance with labeling governance requirements and associated business processes. - Leads label working groups (LWG) and represents labeling at product-specific global regulatory teams and senior labeling governance meetings: Label Review Group (LRG) and Executive Label Review Group (ELRG). - Plans and leads development and maintenance of global product labeling for one or more products, including CCDS and regional labeling (Prescribing Information [PI], Patient Information [PIL], Instructions For Use [IFU]) for select markets (e.g., US, EU, GB, CA). - Leads labeling strategy with expert ability to advise stakeholders of regulatory labeling requirements and provide oversight of health authority interactions (responses to questions, negotiations, and inspections) regarding all aspects of labeling. - Conducts research related to labeling precedent, regulations, policies, and other topics as necessary to properly advise on potential labeling impacts, strategies, or outcomes. - May lead one or more therapeutic areas and be responsible for the strategic development and lifecycle management of labeling for that/those area(s), including TLPs. Knowledge and Skills - Experience leading labeling development and regulator negotiation activities for an initial marketing application or major indication expansion. - Ability to synthesize complex concepts and actions into simple and clear messaging; communicating at all levels of the organization, from specialized experts to executive management. - Specialized depth of knowledge regarding labeling requirements globally, including development and life-cycle management of CCDS and of global regulatory authorities, including the FDA, EMA, and may include other authorities such as Health Canada, TGA. - Advanced ability to develop, use, and apply knowledge of frameworks specific to regulatory labeling, and to use this information to support regulatory responsibilities that align with business objectives. - Advanced ability to plan, prioritize, lead, and execute individual work, teamwork, and projects related to regulatory labeling in a systematic and efficient manner. - Strong attention to detail with a quality-driven mindset. - Strong understanding of the compliance and operational requirements for labeling. - Demonstrates the ability to effectively adopt and leverage emerging technologies, including structured content management for labeling, AI-driven tools, and eLabeling technologies. - Maintains a continuous learning mindset to strengthen Regulatory Labeling decision-making and operational efficiency. - Proactively remains up to date on advances in technology, AI, automation, competitive intelligence and changes in the Regulatory environment. Education and Experience - Bachelor’s degree - Typically requires 10 years of experience in regulatory affairs in the area of global labeling or related discipline, or the equivalent combination of education and experience. Pay Range $185,600 - $278,400 Disclosure Statement The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. Benefits At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations: - Medical, dental and vision benefits - Generous paid time off (including a week-long company shutdown in the Summer and the Winter) - Educational assistance programs including student loan repayment - A generous commuting subsidy - Matching charitable donations - 401(k) and so much more Flex Designation Remote-Eligible Flex Eligibility Status In this Remote-Eligible role, you can choose to be designated as: - Remote: work remotely five days per week and come into the office on occasion – you’re always welcome on-site; - Hybrid: work remotely up to two days per week; - On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.
Senior Product Security Engineer
Vertex Inc.Vertex is a global biotechnology company that invests in scientific innovation.
Role Description This role requires practical, hands-on AI fluency. The ideal candidate is comfortable operating directly within the product development lifecycle—understanding how modern AI systems and agents behave, improve over time, and fail—and applying that understanding to product security decisions, acceptance criteria, and release readiness while owning and evolving broader product security strategy, governance, and risk management practices across the organization. - Own and evolve major components of the Product Security strategy, translating product and business risk into actionable, measurable security programs with clear success metrics. - Lead Secure-by-Design initiatives across product teams, embedding security requirements early in product and feature design, and defining secure design patterns, reference architectures, and guardrails that scale. - Lead security architecture reviews, secure code reviews, threat modeling, and application penetration testing, with a focus on systemic risk reduction across a broad range of products. - Establish and own security best practices for AI-enabled product features, model integration, and AI service architectures, including data handling, model access, and inference workflows. - Lead AI-specific threat modeling addressing misuse, data leakage, supply-chain exposure, and abuse scenarios; define security controls and governance requirements specific to AI features and services. - Evaluate the security implications of new AI technologies, tools, and models prior to adoption; embed responsible AI principles—traceability, privacy, bias awareness, transparency, and auditability—into product security decisions. - Drive consistency in how product and AI risks are assessed, documented, tracked, and accepted across the organization. - Serve as advisor to product and engineering on security risk, architectural trade-offs, and risk acceptance decisions. - Mentor and provide technical leadership to other Product Security engineers and serve as an escalation point for complex security decisions. Qualifications - 5+ years of experience in the security domain, including applying security controls to cloud-based technologies and implementing Product Security frameworks such as OWASP, CIS Benchmarks, and Cloud Security Alliance (CSA). - Proven track record of establishing security controls and governance requirements for AI-enabled features, including data handling, model access, and inference workflows. - Hands-on experience with AI product development security, including partnering with engineering and subject matter experts on model evaluation, tuning, and training. - Ability to define evaluation criteria for AI systems and interpret results to inform security requirements and release readiness decisions. - Experience with cloud governance principles and Product Security tooling, including SAST and DAST. - Demonstrated ability to lead threat modeling, secure code reviews, and application penetration testing for complex, cross-cutting security issues. - Demonstrated expertise in defining and scaling secure design patterns, reference architectures, and security guardrails across multiple product teams. - Technical acumen to experiment directly with AI tools and prototypes in support of faster product security validation. Requirements - Bachelor's degree in computer science or a related field; equivalent combination of education, training, and relevant professional experience accepted in lieu of a formal degree. - Experience with DevSecOps practices, zero trust design principles, and cloud incident response. - Experience contributing to the automation of security analysis and testing activities. - Track record of mentoring and providing technical leadership to security engineering teams. Other Qualifications - Communicate with Clarity - Be clear, concise and actionable. Be relentlessly constructive. Seek and provide meaningful feedback. - Act with Urgency - Adopt an agile mentality - frequent iterations, improved speed, resilience. 80/20 rule – better is the enemy of done. Don’t spend hours when minutes are enough. - Work with Purpose - Exhibit a “We Can” mindset. Results outweigh effort. Everyone understands how their role contributes. Set aside personal objectives for team results. - Drive to Decision - Cut the swirl with defined deadlines and decision points. Be clear on individual accountability and decision authority. Guided by a commitment to and accountability for customer outcomes. - Own the Outcome - Defined milestones, commitments and intended results. Assess your work in context, if you’re unsure, ask. Demonstrate unwavering support for decisions. Pay Transparency Statement Base pay offered to new hires may vary based upon factors including relevant industry and job-related skills and experience, geographic location, and business needs. The range displayed does not encompass the full potential of the role, which allows for further growth and career progression. In addition, as a part of our total compensation package, this role may be eligible for the Vertex Bonus Plan (VOB), a role-specific sales commission/bonus, and/or equity grants. Learn more about Life at Vertex and connect with your recruiter for more details regarding Vertex's compensation and benefit programs. In no case will your pay fall below applicable local minimum wage requirements.
Director, Patient Safety ICSR
Vertex Inc.Vertex is a global biotechnology company that invests in scientific innovation.
Role Description The Director, Global Patient Safety Individual Case Safety Report (ICSR) oversees global ICSR processing and external PV partners and vendors. This position manages the technical aspects of end-to-end safety case intake, processing, quality control, and regulatory submissions within a therapeutic area (as assigned), ensuring operations are consistent, compliant, and inspection-ready worldwide. This role plays a key role in global ICSR processing excellence and external business management, serving as a subject matter expert in pharmacovigilance (PV) and contributing to developing and implementing standards and best practices in Global Patient Safety (GPS), particularly for legislation governing drug-device combination products. The position requires strong technical PV expertise, communication, project management, and vendor management skills, supporting key GPS operational goals and objectives. Key Duties and Responsibilities - Builds and leads an initiative-taking, efficient, and effective team. - Cross-functional collaboration to establish, implement, and oversee processes pertaining to drug-device combination product quality complaint triage and adverse event reporting. - Contribute to the implementation of Global Safety Database configurations for drug-device combination products as required. - Contributes to the ongoing development of innovative ICSR best practices. - Leads and mentors staff in all aspects of PV (pre- and post-market), including stakeholder engagement, project maintenance, and delivery of high-quality cases on time. - Provides guidance to staff on technical aspects of clinical trials and post-market case processing. - Contributes to the development of standardized practices, procedures, metrics, and Key Performance Indicators (KPIs). - Provides management and oversight of business partners and vendors, including PV agreements, safety reporting plans, and vendor contracts, as applicable. - Represents GPS in cross-functional initiatives and meetings. - Promotes a culture of high performance and accountability. - Inputs technical expertise to the production of compliance and operational reports. - Maintains currency with evolving international guidance and regulations for PV, especially regarding ICSR processes and reporting requirements. - Collaborates with GPS Quality, Standards & Training in the identification and remediation of regulatory/compliance risks and quality improvements. - Assists with direct case processing activities, as needed. Qualifications - Firsthand experience with all operational aspects of ICSR processing and reporting specifically pertaining to drug-device combination legislation and implementation. - Line management experience preferred. - Excellent project management skills with the ability to align internal and external resources. - Possess a keen sense of responsibility, ability to work autonomously, and be a strong collaborator. - Ability to manage and react constructively in a high-energy and demanding environment. - Excellent interpersonal and communication skills including verbal/written and presentation skills. - Ability to evaluate and analyze procedural gaps. Requirements - B.S. (or equivalent) in life sciences or allied health professional degree with 10+ years of direct pre- and post-marketing PV experience required. - 5+ years of direct external partner and vendor/outsourcing management experience required. Benefits - Annual bonus and annual equity awards. - Medical, dental, and vision benefits. - Generous paid time off, including a week-long company shutdown in the Summer and Winter. - Educational assistance programs including student loan repayment. - Generous commuting subsidy. - Matching charitable donations. - 401(k) and more. Flex Designation - Remote-Eligible - Remote: work remotely five days per week and come into the office on occasion. - Hybrid: work remotely up to two days per week. - On-Site: work five days per week on-site with ad hoc flexibility. Company Description Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.
Collections Specialist II
Vertex Inc.Vertex is a global biotechnology company that invests in scientific innovation.
Role Description Manage an assigned portfolio of client accounts, ensuring timely collection of outstanding invoices and resolution of payment-blocking issues. - Review and analyze AR Aging Reports; initiate proactive outreach to past-due customers and execute escalation and service hold protocols as required. - Execute daily Oracle invoicing and billing processes, coordinate exceptions, and submit invoices through customer portals to support prompt payment. - Build and maintain productive working relationships with internal and external stakeholders to support collections outcomes and customer satisfaction. - Maintain accurate customer profiles, collection notes, and account files, including documentation for Key, Major, and Alliance accounts with non-standard contractual terms. - Partner cross-functionally to identify process improvements that enhance operational efficiency, accelerate cash flow, and reduce Days Sales Outstanding (DSO). - Contribute to team coverage needs and participate in assigned projects and continuous improvement initiatives. Qualifications - Four or more years of experience in collections, credit, accounts receivable, or general accounting. - Minimum three years of direct customer-facing experience in a business-to-business (B2B) environment. - Demonstrated proficiency with ERP systems; Oracle experience strongly preferred. - Working knowledge of basic GAAP principles and the order-to-cash cycle. - Ability to review and interpret contracts governing financial obligations for both the customer and the organization. - Strong written and verbal communication skills; capable of managing complex billing and collections conversations with professionalism. - Proficient in Microsoft Office, with applied expertise in Excel and Word. Preferred Qualifications - Experience in the software or professional services industry. - Familiarity with customer payment portals and multi-channel billing workflows. - Demonstrated ability to identify process gaps and collaborate across departments to implement operational improvements. - Equivalent combination of education, training, and relevant professional experience accepted in lieu of a formal degree. Pay Transparency Statement US Base Salary Range: $47,000.00 - $61,100.00 Base pay offered to new hires may vary based upon factors including relevant industry and job-related skills and experience, geographic location, and business needs. The range displayed does not encompass the full potential of the role, which allows for further growth and career progression. In addition, as a part of our total compensation package, this role may be eligible for the Vertex Bonus Plan (VOB), a role-specific sales commission/bonus, and/or equity grants. *In no case will your pay fall below applicable local minimum wage requirements.
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