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Planning and Forecasting Senior Finance Analyst
Pastelowa 10, Grunwald, Poznań
Wygasła: 02.05.2024
full-time
umowa o pracę
hybrid work
senior specialist (Senior)
Obowiązki:
Financial Analysis & Planning: Conducting in-depth analysis of financial data, evaluating market trends, and assisting in the creation of market-specific strategic plans
Forecasting & Budgeting: Working with cross-functional teams to develop accurate forecasts, budgets, and financial models that meet the unique requirements of each market
Insights & Reporting: Producing monthly management reports (Demand Review Meeting, Monthly Performance Reviews and Core Commercial Cycles), variance analysis, risks and opportunities for management to review and drive business performance/gap closing initiatives and be the single point of contact for management reporting for this market
Preparing ad hoc reporting requests from in-market finance teams or FM, such as trend analysis for a product type
Cross-functional collaboration: Working with Finance, Operations, and Market Entry teams to ensure that financial strategies are aligned with broader business objectives
Continuous improvement: Identification of opportunities to improve and standardize financial planning and analysis processes to support scalability and efficiency
Contribute to the reporting of financial results for commercial entities under responsibility with commentary including income, balance sheet and cash flow; responsible for smaller entities
Perform month end close activities
Support Finance Controller with business performance analyses related to Sales and Opex
Cooperate with Local Financial Team, present & discuss outcomes of financial analyses
Manage Operating Expenditure and all reporting requirements
Ensure entities results are fully compliant with internal controls and relevant accounting standards, current best practice and any other regulations
Ensure C&C support provided to respective Finance teams is fully compliant with all relevant standards, current best practices, procedures/policies, and SLA
Work proactively to integrate and drive efficient processes in support of reporting & costs analysis
Ensure business complies with all aspects of the internal/external financial control environment, including published accounting papers and policies
Support and is responsible for the inputs to the external and internal financial audits
Manage all aspects of the financial month-end process, including OPEX and Headcount reporting requirements, facilitating month-end meetings, coordinating with all involved partners
Manage Master Data requests (coordination, approval, etc.)
Execute sourcing strategies for spend categories in scope of responsibility aligned with the requirements of stakeholders and business partners with cooperation with Global Categories team
Deliver benefits identified in strategies, local, regional and global, through effective and collaborative strategy execution, aligned to assurance of supply (risk management), quality, service, cost and innovation
To ensure Haledon’s Procurement policies, procedures, processes, systems and methodologies are utilized in a compliant manner in the area of responsibility
Support category leads in the creation and delivery of effective savings targets agreed with key stakeholders and Finance in accordance with the agreed Savings Methodology
Deliver values identified in strategies, local, regional and global, through effective and collaborative strategy execution, aligned to assurance of supply (risk management), quality, service, cost and innovation
Deliver savings and other set KPIs critical to global procurement plans as aligned with key stakeholders and Finance in accordance with the Savings Methodology and global budgets
Collaborate with key stakeholders to deploy strategies globally/regionally, facilitated by robust implementation and transition plans
Demonstrated success in collaboration with a wide range of senior leaders across business areas and suppliers
Resolve escalations, including from senior business stakeholders, timely and tactfully
Understand and efficiently navigate organizational complexity to deliver set goals
Supporting employees and managers throughout the employee lifecycle by providing "how do I" advice and coaching on HR procedures (processes & policies) covering key topics such as onboarding, benefits, payroll, and leave of absence
Managing cases and transactions in Service Now and Workday, including managing data and keeping employee records up to date for all employee lifecycle processes (e.g. hiring, promotion, leaving)
Acting as a single point of contact for the business and triaging to SMEs, 3rd party HR providers & CoEs to ensure timely resolution to meet agreed service level agreements
Assisting employees with benefits enrolment and liaising with benefits providers to ensure benefits (including pension providers, life insurance, health insurance, etc.) are set up and terminated in accordance with policy
Managing internal moves within Workday and creating/modifying contractual terms and conditions (changing reporting lines, working schedules, compensation structures, etc.)
Providing reporting and administrative services to Tiers 2 and 3, including the preparation of HR documentation such as employment contracts, new hire forms and employee handbooks
Maintaining employee files
Helping to improve and streamline processes by working with the Performance and Change team
Using the dashboard and available data analytics to ensure personal performance meets all agreed service standards
Contract Management - Manage own portfolio of license agreements and develop coverage abilities for several royalty agreements from other team member’s portfolio
Make sure all finance-related implications of license agreements in your portfolio are duly managed in accordance with the contracts
Month-end processes - Prepare analysis and journals for monthly royalty accruals, balance sheet reconciliations, commentary, and Sarbanes Oxley control responsibilities
Manage the Vaccines license portfolio
Calculate royalty payments. Trigger and monitor the royalty payment process in cooperation with GSK P2P team
Controls – ensure the compliance of financial reporting to third parties with respective license agreements and internal compliance with applicable Sarbanes Oxley controls
Prepare feedback for internal and external audit
Forecasting and Budgeting, including among others the preparation of annual Budget royalty rates, royalty income, royalty expense for your portfolio of products
Relationship Management and Continuous Improvement - Develop business partnership and seek opportunities to drive process improvements and report standardization
Contribute to the reporting of financial results for commercial entities under your responsibility including review and commentary for income statement, balance sheet and cash flow;
Perform month end close activities
Support Finance Controller with business performance analyses related to Sales and Opex
Collaborate with broader financial team, including Finance Partners, Finance Directors and Operations Centre, present & discuss outcomes of financial analyses
Review high risk account reconciliations
Ensure entities results are fully compliant with internal controls and relevant accounting standards, current best practice and any other regulations
Support agile BI development projects with cooperation and collaboration of other analysts and technical specialists
Support to build new BI products or features and resolve issues with current one e.g. user error/guidance, data queries & analysis including executing data reconciliation activities
Support in delivery of projects working with SMEs, advising proper methodology to refine requirements and deliver technical build in Power BI and manage project documentation
Escalate issues and requests for prioritisation to Product Manager
Work effectively with Tech team, Data CoE and any third-party development teams to create new reports/dashboards
Write help & guidance documentation associated with PDA dashboards / BI solutions and lead demos and training sessions on the dashboards as needed
Design rich data visualisations, using them to communicate complex messages to leaders in simple and clear way
Manage reporting processes for GSK entities to support monitoring of compliance with internal policies/processes and external regulations of contracts with and payments to external experts, healthcare professionals and healthcare related organizations
Ensure accuracy, completeness, timeliness and reconciliation of data between multiple systems and databases
Provide internal and external customer support as needed to facilitate the analysis during the conduct of business
Interact with other areas within and outside GSK in support of business transactions and to coordinate efforts across internal and external areas
Maintain database of payments and supplemental information to meet all state reporting, regulatory and management reporting requirements
Identify, recommend and assist in the implementation of continuous improvement initiatives
Provide historical information on transactions in support of requests from the Legal and Compliance departments of GSK
Providing accounting service in Close & Control CAPEX area for Vaccines segment (intangibles, IFR16, inventory of fixed assets, financial statements disclosures related to capex)
Coordination of the month-end activities within the CAPEX team
Taking care of good relations with main stakeholders in local entities
Providing month-end reconciliations and various analysis
Performing SOX controls related activities
Accruals calculation and other postings entry in SAP system
Performing fluctuation analysis both in balance sheet and in profit & loss
Being in close contact with finance controlling team responsible for reporting
Implementing new functionalities (mostly in Apex, LWC and when needed using Salesforce Out of The Box configuration options). We are committed to no longer use VisualForcePages and Aura (transition in progress)
Working closely with Product Experts and sometimes Markets on gathering requirements and providing technical Solution Designs
Developing good quality code: according to industry standards, with Unit Tests (we encourage you to use TDD/DDD methodology), using static code analysis tool (SonarQube) and taking part in Code Review process
Partnering with Support Team throughout the delivery lifecycle of your changes
Working in 2-week-long Sprints with other Developers, Engineers, Product Experts and Scrum Master (using Jira and Confluence and participating in ceremonies: backlog refinements, sprint plannings, daily scrums and retrospectives)
Responsible for developing and building IT solutions for the R&D Regulatory applications. This involves designing and coding software components, ensuring functionality and usability, and adhering to coding standards
Contributing to the design and architecture of the systems supporting the R&D Regulatory applications. This involves evaluating and recommending appropriate technologies, frameworks, and infrastructure components to enhance the application's efficiency and scalability
Addressing and resolving bugs and technical issues related to the R&D Regulatory applications
Providing support to users of the R&D Regulatory applications. This includes responding to user inquiries, troubleshooting user-reported issues, and offering guidance and training to ensure smooth and effective usage of the application
Overseeing the management and maintenance of the IT infrastructure supporting the R&D Regulatory applications
Continuous Improvement: Proactively identifying opportunities for continuous improvement in the R&D Regulatory applications and related systems. This includes staying updated with industry best practices, exploring new technologies, and implementing enhancements to optimize performance, security, and user experience
Support employees and managers across full employee lifecycle through advisory (“how do I?”) and coaching on HR procedures (process & policy) covering key topics e.g. onboarding, benefits, payroll, leave of absence
Management of cases and transactions in Service Now and Workday, including data management and keeping employees records up to date for all employee lifecycle processes (i.e. hirings, promotions, leavers)
Acting as the single point of contact for the business and triaging to SMEs, 3rd Party HR service providers & CoEs to ensure timely resolution to meet agreed service level agreements
Support employees with benefits enrolment and liaise with benefits providers to ensure set up and termination of benefits (including pension providers, life insurance, health insurance, etc.) according to policy
Manage internal moves in Workday and create / alter contractual terms and conditions (change in reporting line, work schedules, compensation structure etc.)
Provide reports and administrative services to Tiers 2 and 3 including preparation of HR documentation e.g. contracts of employment, new hire forms and employee handbooks
Maintenance of employee files
Contribute to improving and streamlining processes by partnering with performance and change team
Use dashboard and available data analytics to ensure personal performance meets all agreed service standards
Support employees and managers across full employee lifecycle through advisory (“how do I?”) and coaching on HR procedures (process & policy) covering key topics e.g. onboarding, benefits, payroll, leave of absence
Management of cases and transactions in Service Now and Workday, including data management and keeping employees records up to date for all employee lifecycle processes (i.e. hirings, promotions, leavers)
Acting as the single point of contact for the business and triaging to SMEs, 3rd Party HR service providers & CoEs to ensure timely resolution to meet agreed service level agreements
Support employees with benefits enrolment and liaise with benefits providers to ensure set up and termination of benefits (including pension providers, life insurance, health insurance, etc.) according to policy
Manage internal moves in Workday and create / alter contractual terms and conditions (change in reporting line, work schedules, compensation structure etc.)
Provide reports and administrative services to Tiers 2 and 3 including preparation of HR documentation e.g. contracts of employment, new hire forms and employee handbooks
Maintenance of employee files
Contribute to improving and streamlining processes by partnering with performance and change team
Use dashboard and available data analytics to ensure personal performance meets all agreed service standards
Carry out close activities in the areas of banking, inter-co financing, cash management related derivatives and accounts receivable in a robust and efficient manner
Ensure compliance with internal policies and GSK Internal Control Framework (Sarbanes-Oxley) by performing and reviewing a set of control actions and driving remediation where required, in the areas of banking, treasury and accounts receivable
Prepare Balance Sheet Reconciliations, drive quality and resolution of open items, assess BS healthiness and surface risks to be addressed in connection with inter-co financing, cash pooling activities and banking operations with external banks
Monitor cash position for a portfolio of entities, ensuring cash utilization to maximize returns and minimize costs
Drive hedging programs to minimize foreign exchange differences, periodically analyse the resulted differences and present the analysis to senior stakeholders
Perform Order-to-Cash activities, including credit limit review, credit checks, bad debts management, and present facts to senior stakeholders
Support market Financial Controllers in period end financial closing activities by providing fluctuation analysis in the areas of treasury/inter-co financing and foreign exchange differences and financial statement disclosures and ensure efficient & effective close is performed and accurate disclosures are made
Ensure that certain treasury related activities are carried out in a robust and efficient manner by our partner BPO, i.e. closely monitoring their performance in clearing transit account open items
Liaise with internal and external auditors, providing requested evidence
Liaise with statutory reporting team, providing requested information and analysis
Oversee the activities of Junior Reporting Specialist in the treasury and accounts receivable area
Accountable for all aspects of strategy, product delivery and operations for the E2E Visibility and Alert products across the supply chain, inclusive of external 3rd party customers, CMOs, and suppliers
Develop a product improvement pipeline to meet business goals and objectives in the areas of E2E Visibility and Alert
Take full accountability and provide oversight for the successful delivery of all experiments and projects within the product scope
Oversee overall E2E Visibility and Alert applications service performance ensuring that the risks and value associated with the applications are effectively managed over their lifecycle
At Business Unit Level: Success will be measured by achieving the maximum value for the business while ensuring the E2E Visibility and Alert applications operate at an optimal cost vs risk level
Provides input to Product architecture, aligning across the Tech organisation on standards relating to platforms, cyber security, strategic vendors & delivery models. Ensure robust governance are in place and lead governance bodies to approve experiments and product improvement projects
Contribute to the reporting of financial results for commercial entities under your responsibility, including performance commentary for market operating profit and balance sheet
Support Finance Controller with business performance analyses related to Sales and Opex
Take full ownership for results reporting of one/two smaller European markets
Perform regular month end close activities, including among others: review of accounts, necessary postings, execution of internal controls
Serve as a key contact and contributor for local Finance Director, present & discuss accounting and reporting matters
Facilitate or deliver accounting and reporting issue resolution, collaborating with specialized accounting towers in GSK Operations Centre
Ensure entities results are fully compliant with internal controls and relevant accounting standards, current best practice, and any other relevant regulations
Developing and building IT solutions for the Safety applications by designing and coding software components, ensuring functionality and usability, and adhering to coding standards
Addressing and resolving bugs and technical issues related to the Safety applications
Providing support to users of the Safety applications by responding to user inquiries, troubleshooting user-reported issues, and offering guidance and training to ensure smooth and effective usage of the application
Overseeing the management and maintenance of the IT infrastructure supporting the Safety applications
Contributing to the design and architecture of the systems supporting the Safety applications
Evaluating and recommending appropriate technologies, frameworks, and infrastructure components to enhance the application's efficiency and scalability
Proactively identifying opportunities for continuous improvement in the Safety applications and related systems
Provide leadership and consultation to BU stakeholders on Digital & Tech investments and value-add activities in alignment and support of business strategic initiatives
Work with CH Digital & Tech Global Team and manage, plan and bring harmonization across Global Digital & Tech systems and platforms to ensure the successful and on-time strategy deployment for all Digital & Tech projects
Ensure Digital & Tech budget and funding is clearly defined to request endorsement by all stakeholders at the right level
Translate vision & strategy into a BU D&T product roadmap in partnership with global D&T
Understand the BU\Market business and user needs to bring to the central teams and evaluate need for customization to support growth
Customer centric to drive value of the global products, play the last mile in value articulation and product adoption
Working across Digital & Tech to ensure ERP, core Digital & Tech, global products etc. are working for the BU
Understand Global market environment and identify Global specific business needs which could not be fulfilled by global products, design, plan and implement local product/platforms such as Global Enterprise Datalake, Global CDP, SCRM, DTC etc to support fast market growth
Define and measure metrics for business benefits and tech measures
Develop a clear understanding of the core entities and accountabilities with the process for business impact and strategic change, provide input into the process change and business benefit of its implementation
Deconstruct complex processes into manageable simplified representations that facilitate strategic discussion and decision making
Ensure all applications supporting the business are compliant with security, risk management policies and practices, external regulatory and statutory requirements e.g., GxP, Sarbanes-Oxley, CSL and that IT continuity plans are in place for all business-critical applications
Develop and support local products
Project Manage D&T global/local project implementations for the BU
Coach and develop the BU tech team with skills required to deliver D&T roadmap, e.g., BI, MarTech
Research threat actors and their associated tools, tactics, procedures, and goals
Research emerging threats from malware samples, exploitation attempts, and other evidence of staged malicious infrastructure and activity
Produce relevant written tactical and strategic intelligence reports from threat intelligence research and emerging cyber security events
Contribute to regular situational updates for distribution to security operations teams, information technology teams, enterprise risk management teams, and executive decision makers
Maintain threat indicators and correlations to malicious threat actors and campaigns
Collaborate with and support Incident Response, Security Operations, Security Analytics, Network Security, and Endpoint Security teams
Guide proactive measures to prevent and detect cyber security threats, while providing contextual information from threat intelligence research
Complete and assist in the management of Level 1 and Level 2 DLP alerts across multiple tools. Be comfortable in analysing data and making judgement calls on escalating and prioritising incidents
Engage with users and business partners to understand incidents and mange escalations
Investigate security incidents using data analytics, computer forensics, and automation in production and corporate environments
Lead in the development and improvement of reporting metrics and data analysis and reporting
Assist in the development and improvement to our Case Management tool
Provide direct technical recommendations for the program to include building process and governance around how the team operates across business segments to include HR, Privacy, Corporate Investigations and Legal
Working with peers across the CISO organisation to identify security solutions to enhance and improve the technology, process and procedures used by the Insider Threat team
Working with strategic vendor partners across the business to ensure visibility to data sets and vendor access/usage of corporate network resources
Analyse the latest insider threat techniques and apply solutions to detect them holistically
Managing multiple CMC (Chemistry, Manufacturing and Control) renewals assignments for Pharma and Vaccines products including response to questions from Agency
Define and agree regulatory strategy, complete data assessment to ensure CMC dossier authored in compliance with Company regulatory processes and external requirements for international markets
Working with colleagues in Global Manufacturing & Supply and GSK Local Operating Companies in markets worldwide to deliver high quality dossier on time
Monitoring regulatory intelligence and act proactively on identified changes to regulatory requirements
Effective communication also in a digital context, including virtual meetings and digital platforms
Act as subject matter expert in regulatory processes
Evaluating and implementing innovative solutions for CMC Regulatory processes, policies and systems
Supporting digital transformation through active participation in building digital skills
Managing multiple CMC (Chemistry, Manufacturing and Control) renewals assignments for Pharma and Vaccines products including response to questions from Agency
Define and agree regulatory strategy, complete data assessment to ensure CMC dossier authored in compliance with Company regulatory processes and external requirements for international markets
Working with colleagues in Global Manufacturing & Supply and GSK Local Operating Companies in markets worldwide to deliver high quality dossier on time
Monitoring regulatory intelligence and act proactively on identified changes to regulatory requirements
Effective communication also in a digital context, including virtual meetings and digital platforms
Act as subject matter expert in regulatory processes
Evaluating and implementing innovative solutions for CMC Regulatory processes, policies and systems
Supporting digital transformation through active participation in building digital skills
Primarily responsible for the delivery of SMAS (Specialised Management Accounting Services) processes according to agreed operating model and/or Service Level Agreements whilst ensuring full compliance with GSK and external accounting policies
Operate according to governance frameworks, policies and internal controls (SOX /Audit), prepare reconciliations for Balance Sheet accounts in scope as well as other relevant accounting controls
Ensure that Site Actuals are accounted for and reported in an accurate and timely fashion for the assigned processes to support reliable, informed business decisions
Align and partner with Site Finance to review results against plans and identify improvement opportunities
Communicate and present information in a way that stakeholders can easily visualize and understand it to evaluate performance, exploit business opportunities or manage risk
Build strong working relationships with customer groups and stakeholders, manage stakeholder expectations and needs, communicate effectively in all interactions through various means
To manage own time appropriately to ensure assigned processes are performed and delivered in line with agreed timelines, and according to standard work approach
Seek development and improvement, to deliver a level of expertise in assigned process to the benefit of SMAS group and site customers
To actively support the SMAS culture of continuous improvement within the cluster and across the SMAS, striving for standardization and improved performance to support delivery of wider organizational objectives
Execute sourcing strategies for spend categories in scope, aligning with the requirements of business stakeholders, and cooperating with Procurement Global Category and Manufacturing Sites;
Negotiate contracts with suppliers that secure favorable terms for procurement of goods and services contracts in line with the agreed business requirements;
Deliver benefits identified in strategies, local, regional and global, through effective and collaborative strategy execution, aligned to assurance of supply (risk management), quality, service, cost and innovation;
Ensure GSK’s Procurement policies, procedures, processes, systems and methodologies are utilized in a compliant manner in the area of responsibility;
Deliver savings and other set KPIs critical to global procurement plans as aligned with key stakeholders and Finance in accordance with the Savings Methodology and global budgets;
Collaborate and build relationships with GSK leadership teams, to identify and deliver business benefits aligned to assurance of supply, quality, service, cost and innovation requirements;
Resolve escalations, including from senior business stakeholders, timely and tactfully
Design, implement and embed clear business intelligence reporting to enable business services to process information to drive strategic business actions effectively and efficiently
Build algorithms and design experiments to merge, manage, interrogate and extract data to supply tailored reports to colleagues, customers or the wider organisation
Establish and embed service process improvements and problem solving using data mining and management techniques where applicable to increase operational efficiency
Analyzing business service performance through design and delivery of key performance indicators and reporting across business services
Maintain governance and infrastructure for Data Analytics, including Databases, Power BI workspace, documentation, DevOps
Maintain clear and coherent communication, both verbal and written, to understand data needs and report results
Use machine learning tools and statistical techniques to produce solutions to problems
In your new role you will provide set of financial activities during the monthly cycle, to ensure accurate and
timely postings of financial transactions
Your core goal will be to deliver a timely period end close. These activities will include analysis of entries, preparation & review of journals, preparing a set of internal controls activities, etc
You will be reviewing the Balance Sheet Reconciliations prepared by Operations Centre, driving quality and resolution of open items, assessing balance sheet health and flagging risks to be addressed
You will work closely with Site Controllers in UK, Spain or France, to ensure activities are properly carried out in the accounting area. You will also assist in resolving queries and or issues as well as support annual audit process
You will be reviewing monthly reporting of financial data as an input for group consolidation and resolving related queries
You will ensure full compliance with IFRS and SOX requirements
Participation in development of the Company Core Datasheet (Global Product Information) for new medicines or product line extensions
Maintenance of country/regional labelling in compliance with GSK labelling processes and external requirements for local markets e. g. Europe (for Centralized, Mutual Recognition and Decentralized procedure submissions), US and International countries
Managing core and local prescribing/patient information throughout the product lifecycle
Working with colleagues in GSK Local Operating Companies in markets worldwide to ensure the company core datasheet is accurately reflected in local prescribing/patient information
Authoring responses to prescribing/patient information questions from Regulatory Authorities
Providing Local Operating Companies with required documents for national labelling submissions
Participation in development of the Company Core Datasheet (Global Product Information) for new medicines or product line extensions
Maintenance of country/regional labelling in compliance with GSK labelling processes and external requirements for local markets e. g. Europe (for Centralized, Mutual Recognition and Decentralized procedure submissions), US and International countries
Managing core and local prescribing/patient information throughout the product lifecycle
Working with colleagues in GSK Local Operating Companies in markets worldwide to ensure the company core datasheet is accurately reflected in local prescribing/patient information
Authoring responses to prescribing/patient information questions from Regulatory Authorities
Providing Local Operating Companies with required documents for national labelling submissions
Partner the in-market Finance Teams, Country Finance Manager and other colleagues in your assigned countries to create Forecasts, Plan and Update exercises for P&L
Strong understanding of actual/ historical performance, external environment and able bring into planning and forecasting considerations
Prepare management reports on monthly basis (Demand Review Meeting, Monthly Performance Reviews and Core Commercial Cycles), variance analysis, risk & opportunities for management to review and drive business performance/gap closing initiatives and be the single point of contact for management reporting for that market
Prepare ad-hoc reporting requests from in-market finance teams or the FM e.g., trend analysis for a product type
Partner the in-market Finance Teams, Country Finance Manager and other colleagues in your assigned countries to create Forecasts, Plan and Update exercises for P&L
Strong understanding of actual/ historical performance, external environment and able bring into planning and forecasting considerations
Prepare management reports on monthly basis (Demand Review Meeting, Monthly Performance Reviews and Core Commercial Cycles), variance analysis, risk & opportunities for management to review and drive business performance/gap closing initiatives and be the single point of contact for management reporting for that market
Prepare ad-hoc reporting requests from in-market finance teams or the FM e.g., trend analysis for a product type
Accountable for all aspects of strategy, product delivery and operations for the E2E Visibility and Alert products across the supply chain, inclusive of external 3rd party customers, CMOs, and suppliers
Develop a product improvement pipeline to meet business goals and objectives in the areas of E2E Visibility and Alert
Take full accountability and provide oversight for the successful delivery of all experiments and projects within the product scope
Oversee overall E2E Visibility and Alert applications service performance ensuring that the risks and value associated with the applications are effectively managed over their lifecycle
At Business Unit Level: Success will be measured by achieving the maximum value for the business while ensuring the E2E Visibility and Alert applications operate at an optimal cost vs risk level
Provides input to Product architecture, aligning across the Tech organisation on standards relating to platforms, cyber security, strategic vendors & delivery models. Ensure robust governance are in place and lead governance bodies to approve experiments and product improvement projects
Research threat actors and their associated tools, tactics, procedures, and goals
Research emerging threats from malware samples, exploitation attempts, and other evidence of staged malicious infrastructure and activity
Produce relevant written tactical and strategic intelligence reports from threat intelligence research and emerging cyber security events
Contribute to regular situational updates for distribution to security operations teams, information technology teams, enterprise risk management teams, and executive decision makers
Maintain threat indicators and correlations to malicious threat actors and campaigns
Collaborate with and support Incident Response, Security Operations, Security Analytics, Network Security, and Endpoint Security teams
Guide proactive measures to prevent and detect cyber security threats, while providing contextual information from threat intelligence research
Provide leadership and consultation to BU stakeholders on Digital & Tech investments and value-add activities in alignment and support of business strategic initiatives
Work with CH Digital & Tech Global Team and manage, plan and bring harmonization across Global Digital & Tech systems and platforms to ensure the successful and on-time strategy deployment for all Digital & Tech projects
Ensure Digital & Tech budget and funding is clearly defined to request endorsement by all stakeholders at the right level
Translate vision & strategy into a BU D&T product roadmap in partnership with global D&T
Understand the BU\Market business and user needs to bring to the central teams and evaluate need for customization to support growth
Customer centric to drive value of the global products, play the last mile in value articulation and product adoption
Working across Digital & Tech to ensure ERP, core Digital & Tech, global products etc. are working for the BU
Understand Global market environment and identify Global specific business needs which could not be fulfilled by global products, design, plan and implement local product/platforms such as Global Enterprise Datalake, Global CDP, SCRM, DTC etc to support fast market growth
Define and measure metrics for business benefits and tech measures
Develop a clear understanding of the core entities and accountabilities with the process for business impact and strategic change, provide input into the process change and business benefit of its implementation
Deconstruct complex processes into manageable simplified representations that facilitate strategic discussion and decision making
Ensure all applications supporting the business are compliant with security, risk management policies and practices, external regulatory and statutory requirements e.g., GxP, Sarbanes-Oxley, CSL and that IT continuity plans are in place for all business-critical applications
Develop and support local products
Project Manage D&T global/local project implementations for the BU
Coach and develop the BU tech team with skills required to deliver D&T roadmap, e.g., BI, MarTech
Developing and building IT solutions for the Safety applications by designing and coding software components, ensuring functionality and usability, and adhering to coding standards
Addressing and resolving bugs and technical issues related to the Safety applications
Providing support to users of the Safety applications by responding to user inquiries, troubleshooting user-reported issues, and offering guidance and training to ensure smooth and effective usage of the application
Overseeing the management and maintenance of the IT infrastructure supporting the Safety applications
Contributing to the design and architecture of the systems supporting the Safety applications
Evaluating and recommending appropriate technologies, frameworks, and infrastructure components to enhance the application's efficiency and scalability
Proactively identifying opportunities for continuous improvement in the Safety applications and related systems
Complete and assist in the management of Level 1 and Level 2 DLP alerts across multiple tools. Be comfortable in analysing data and making judgement calls on escalating and prioritising incidents
Engage with users and business partners to understand incidents and mange escalations
Investigate security incidents using data analytics, computer forensics, and automation in production and corporate environments
Lead in the development and improvement of reporting metrics and data analysis and reporting
Assist in the development and improvement to our Case Management tool
Provide direct technical recommendations for the program to include building process and governance around how the team operates across business segments to include HR, Privacy, Corporate Investigations and Legal
Working with peers across the CISO organisation to identify security solutions to enhance and improve the technology, process and procedures used by the Insider Threat team
Working with strategic vendor partners across the business to ensure visibility to data sets and vendor access/usage of corporate network resources
Analyse the latest insider threat techniques and apply solutions to detect them holistically
Develop & facilitate forums and processes to govern the strategy, deployment and BAU phases associated with OT & IoT Cyber Security initiatives
Develop a simplification approach to governance that considers the risk reduction framework, as well as attributes of ROI calculations, such that the value of deploying a control is understood
Create & maintain service design materials and procedures relating to OT & IoT Cyber Security, to include strategy for storage, collaboration and where appropriate an open availability of assets for consumption
Build a sustainable engagement & comms plan to ensure key stakeholders understand their roles in protecting Haleon from OT Threats
Support the Engineering & OT Director to attend meetings and stakeholder communication
Facilitate and drive discussion with and between key stakeholder groups , including Product Towers, Site Engineering & Tech teams, office of CISO as well as Infrastructure teams
Monitor & track budget planning and compliance for each initiative
Identify, escalate and manage risks to minimize variances from plan
Develop & facilitate forums and processes to govern the strategy, deployment and BAU phases associated with OT & IoT Cyber Security initiatives
Develop a simplification approach to governance that considers the risk reduction framework, as well as attributes of ROI calculations, such that the value of deploying a control is understood
Create & maintain service design materials and procedures relating to OT & IoT Cyber Security, to include strategy for storage, collaboration and where appropriate an open availability of assets for consumption
Build a sustainable engagement & comms plan to ensure key stakeholders understand their roles in protecting Haleon from OT Threats
Support the Engineering & OT Director to attend meetings and stakeholder communication
Facilitate and drive discussion with and between key stakeholder groups , including Product Towers, Site Engineering & Tech teams, office of CISO as well as Infrastructure teams
Monitor & track budget planning and compliance for each initiative
Identify, escalate and manage risks to minimize variances from plan
Planowanie i przeprowadzanie efektywnych spotkań indywidualnych i grupowych z klientami, w oparciu o systematyczne pogłębianie o nich wiedzy, wdrażanie założeń modelu wizyty sprzedażowej i strategii promocyjnej, w celu maksymalizacji skuteczności przekazu informacji medycznych i kreowania właściwego wizerunku Haleon
Realizację celów firmowych poprzez działania informacyjne, promocyjneoraz wnikliwą analizę sytuacji biznesowej w obszarze dentystycznych wyrobów medycznych
Budowanie wizerunku firmy poprzez udział w targach i kongresach stomatologicznych
Skuteczne zarządzanie obsługiwanym terytorium poprzez stałą analizę potencjału klientów, uzyskiwanych rezultatów, działalności konkurencji i lokalnych uwarunkowań w celu optymalizacji dotarcia do grupy docelowej, wykorzystania zasobów i czasu pracy dla realizacji założonych celów
Rzetelne i terminowe planowanie oraz raportowanie aktywności i wyników oraz aktualizowanie baz danych, zgodnie z wymaganiami Haleon
Systematyczne aktualizowanie wiedzy o produktach, strategii promocyjnej, regulacjach prawnych oraz podnoszenie umiejętności komunikacyjnych, w celu zapewnienia najwyższej jakości przekazu informacji naukowej dla klientów firmy
Skuteczna współpraca z innymi przedstawicielami Haleon w zakresie wymiany informacji oraz prowadzenia wspólnych przedsięwzięć na poziomie regionu
Managing and supervising Controls Testing Plans delivered by our third-party supplier, which includes reviewing controls testing results, and communicating significant issues and areas of exposure to local management and Finance Directors
Managing senior stakeholders very closely regarding risk management and controls and drive a proactive risk mindset in the organization
Performing end-to-end process risk assessments and control deficiencies analysis to identify high areas of exposure, support in root cause analysis and investigation, review and align with the business on remediation plans and actions to reduce risks or resolve deficiencies
Provide Risk management expertise on remediation activities related to control deficiencies and/or process gaps to ensure adequate risk mitigation
Advise on risk management and controls impact to projects and/or continuous improvement initiatives led by the global process tower organization and/or Process Improvement Experts in Global Finance Services (GFS) organization and / or the regional hub leadership team
Support and engage with external audit, and other external or internal bodies in risk and control issues to reduce impact to business, increase reliance, and align on auditor’s assessment of the finance control environment for SOX reporting purposes
Collaborating across the regions to inform and gather intelligence on risks and controls
Global Products & Technology meet the need for clear, accurate, and timely financial and business information, leads appropriately – participates in a regular structured commercial performance review, supervises alignment with agreed contracts, raises any related risks, issues ensuring accurate escalations
Design models and methodologies for future cost modeling and business decisions support; support business in planning and forecasting periodic activities/trend
Prepare and publish reports to partners to show costing progress - track financials, and handle operational budgets. Provide explanations for differences from expectation
Provide financial analysis expertise and insight into the development of strategies
Ensure that commercial transactions are run optimally and in a timely manner - this includes ensuring purchase orders, cross-charging, payments, etc., are all executed correctly and issues are addressed
Receive payable invoices, ensure approvals are received, ensure invoices are in line with alliance agreements, check underlying calculations, liaise with the P2P to process and pay invoices
Calculate and issue receivable invoices related to alliances or transitional services
Track actual spend on alliances vs budget, generate variance analysis and commentary on the variances, communicate commentary to feed into the larger R&D P&L variance analysis. Provide updates to R&D Business Finance Partners
Ensure system coding and master data is set up as appropriate to ensure correct reporting
Prepare cost analysis of costs spent by R&D on specific alliances, e.g. labor, materials, etc., by extracting relevant information from relevant IT systems used across R&D
Prepare reconciliations and commentaries for R&D Alliances balances including receivables and payables
Month-end reporting: Prepare and submit into accounting systems the monthly accounting entries related to relevant alliances, e.g. invoices paid and invoices issued, accrue for unpaid invoices
Customer Service Specialist (with Dutch) in supply chain
Poznań
Wygasła: 15.12.2023
full-time
umowa na zastępstwo
hybrid work
specialist (Mid / Regular)
Obowiązki:
Deliver excellent service to GSK customers (e.g. wholesalers, pharmacies, hospitals, etc.) using various communication channels (e.g. phone/chat/email) processing orders and ensuring supply chain activities continuity
Follow the standards for customer service processes such as: master data management, sales order processing, queries and complaints management, supply chain issue management
Liaise with warehousing, distribution functions and relevant external partners as to supply planning
Build and maintain great relationship with internal and external clients
Engage in continuous process improvement activities
Your post-transition responsibilities will include – but non-exhaustively
Provide set of financial activities related to P&L and Balance Sheet during the monthly cycle to ensure accurate and timely postings of financial transactions, in order to deliver a timely period end close. Activities include (but are not limited to) research & analysis of entries, preparation & review of journals, etc
You will own your entity’s trial balance
Cooperating with our BPO partner to ensure that all activities are carried out in a solid and efficient manner especially performing General Ledger, Period End Close and Balance Sheet Reconciliation activities
Support period end financial closing activities to ensure accurate and timely delivery of the IFRS reports and control the Balance Sheet for your scope
Supervising of everyday BPO partner deliverables as well as designing, embedding and monitoring KPIs and SLAs
Engage in preparing complex analysis and summaries as required
Closing open issues and ensuring right steps to prevent re-occurrence
Reviewing the documentation for all month-end control process, ensuring full compliance with SOX requirements, driving control remediation when necessary
Supporting preparation of statutory accounts and audit deliverables as required
Managing complex situations proactively and drive continuous service improvements
Engage with key finance and non-finance stakeholders as required and manage these relationships
Working closely with teams across the TPF organisation and wider Finance function
Manage and support one or more accountants /analysts
Authoring and compiling Regional/Country PI and market-specific supporting documentation as per regulatory authority labelling requirements and GSK process and standards
Providing support to global and local GRA team members through preparation of other labelling documents as required
Complete quality and consistency checks of labelling document content
Effective coordination and management of labelling documentation and data in regulatory systems
Providing advice regarding regulatory authority labelling requirements and GSK labelling process and standards to GRA global/local roles and via Regulatory Matrix Teams
Effective communication with GSK staff (including GRA, Global safety and medical, and Local Operating Companies) to author, compile and deliver quality labelling documents
Supporting other regulatory functions and participating in other projects and activities as needed, such as leading the design and implementation of changes to labelling processes and evaluation of new agency labelling requirements
Take accountability for the management of labelling deliverables for country/region
Authoring and compiling Regional/Country PI and market-specific supporting documentation as per regulatory authority labelling requirements and GSK process and standards
Providing support to global and local GRA team members through preparation of other labelling documents as required
Complete quality and consistency checks of labelling document content
Effective coordination and management of labelling documentation and data in regulatory systems
Providing advice regarding regulatory authority labelling requirements and GSK labelling process and standards to GRA global/local roles and via Regulatory Matrix Teams
Effective communication with GSK staff (including GRA, Global safety and medical, and Local Operating Companies) to author, compile and deliver quality labelling documents
Supporting other regulatory functions and participating in other projects and activities as needed, such as leading the design and implementation of changes to labelling processes and evaluation of new agency labelling requirements
Take accountability for the management of labelling deliverables for country/region
Managing Market Specific Requirements for Finished Products and Active Pharmaceutical Ingredients in various areas
Complete data assessment to ensure authored regulatory dossier is in compliance with GlaxoSmithKline regulatory processes and external requirements for local markets
Working with colleagues in Global Manufacturing & Supply and GSK Local Operating Companies in markets worldwide to deliver high quality dossier on time
Monitoring regulatory intelligence and act proactively on identified changes to regulatory requirements
Managing Market Specific Requirements for Finished Products and Active Pharmaceutical Ingredients in various areas
Complete data assessment to ensure authored regulatory dossier is in compliance with GlaxoSmithKline regulatory processes and external requirements for local markets
Working with colleagues in Global Manufacturing & Supply and GSK Local Operating Companies in markets worldwide to deliver high quality dossier on time
Monitoring regulatory intelligence and act proactively on identified changes to regulatory requirements
In your new role you will provide set of financial activities during the monthly cycle, to ensure accurate and
timely postings of financial transactions
Your core goal will be to deliver a timely period end close. These activities will include analysis of entries, preparation & review of journals, preparing a set of internal controls activities, etc
You will be reviewing the Balance Sheet Reconciliations prepared by Operations Centre, driving quality and resolution of open items, assessing balance sheet health and flagging risks to be addressed
You will work closely with Site Controllers in UK, Spain or France, to ensure activities are properly carried out in the accounting area. You will also assist in resolving queries and or issues as well as support annual audit process
You will be reviewing monthly reporting of financial data as an input for group consolidation and resolving related queries
You will ensure full compliance with IFRS and SOX requirements
Primarily responsible for the delivery of SMAS (Specialised Management Accounting Services) processes according to agreed operating model and/or Service Level Agreements whilst ensuring full compliance with GSK and external accounting policies
Operate according to governance frameworks, policies and internal controls (SOX /Audit), prepare reconciliations for Balance Sheet accounts in scope as well as other relevant accounting controls
Ensure that Site Actuals are accounted for and reported in an accurate and timely fashion for the assigned processes to support reliable, informed business decisions
Align and partner with Site Finance to review results against plans and identify improvement opportunities
Communicate and present information in a way that stakeholders can easily visualize and understand it to evaluate performance, exploit business opportunities or manage risk
Build strong working relationships with customer groups and stakeholders, manage stakeholder expectations and needs, communicate effectively in all interactions through various means
To manage own time appropriately to ensure assigned processes are performed and delivered in line with agreed timelines, and according to standard work approach
Seek development and improvement, to deliver a level of expertise in assigned process to the benefit of SMAS group and site customers
To actively support the SMAS culture of continuous improvement within the cluster and across the SMAS, striving for standardization and improved performance to support delivery of wider organizational objectives
Regulatory Specialist, Annual Reporting, Site Registration and GMP team
Poznań
Wygasła: 12.11.2023
full-time
umowa o pracę
hybrid work
specialist (Mid / Regular)
Obowiązki:
take responsibility for planning, preparation, technical review, delivery and associated regulatory activities of CMC Annual Reports (for NDAs/BLAs/DMFs, Canadian Annual Notifications, Brazil and China ARs), Site/Facilities variations for GSK’s established product portfolio for both Pharma (Rx) and Vaccine (Vx) products,
work closely and provide CMC regulatory advice and guidance to CMCRA, Pharma Supply Chain (PSC), Local Operating Companies and Regions in order to produce high quality and timely documentation in support of Annual Reporting and Site/Facilities variations,
participate in the creation, improving and implementation of working practices and procedures aimed at simplifying processes and increasing quality,
monitor regulatory intelligence and act proactively on identified changes to regulatory requirements,
manage multiple projects/products simultaneously,
build and maintain good relationships with your internal and external stakeholders,
Regulatory Specialist, Annual Reporting, Site Registration and GMP team
Warszawa
Wygasła: 12.11.2023
full-time
umowa o pracę
hybrid work
specialist (Mid / Regular)
Obowiązki:
take responsibility for planning, preparation, technical review, delivery and associated regulatory activities of CMC Annual Reports (for NDAs/BLAs/DMFs, Canadian Annual Notifications, Brazil and China ARs), Site/Facilities variations for GSK’s established product portfolio for both Pharma (Rx) and Vaccine (Vx) products,
work closely and provide CMC regulatory advice and guidance to CMCRA, Pharma Supply Chain (PSC), Local Operating Companies and Regions in order to produce high quality and timely documentation in support of Annual Reporting and Site/Facilities variations,
participate in the creation, improving and implementation of working practices and procedures aimed at simplifying processes and increasing quality,
monitor regulatory intelligence and act proactively on identified changes to regulatory requirements,
manage multiple projects/products simultaneously,
build and maintain good relationships with your internal and external stakeholders,
Deliver a complete, accurate and timely financial reporting (IFRS) for a set of entities operating in a geographical market or cluster of smaller markets
Ensuring that close activities are carried out in a robust and efficient manner by our partner BPO, i.e. overseeing their performance within General Ledger, Period End Close and Balance Sheet Reconciliation activities
Ensure compliance with internal policies and GSK Internal Control Framework (Sarbanes-Oxley) by performing and reviewing a set of control actions and driving remediation where required
Review the Balance Sheet including reconciliations prepared by the BPO, drive quality (through BPO retraining if necessary) and resolution of open items, assess BS healthiness and surface risks to be addressed
Support market Financial Controller in period end financial closing activities and ensure efficient & effective close is performed
Liaise with internal and external auditors, providing requested evidence
Partner the in-market Finance Teams, Country Finance Manager and other colleagues in your assigned countries (Russia) to create Forecasts, Plan and Update exercises for P&L
Strong understanding of actual/ historical performance, external environment and able bring into planning and forecasting considerations
Prepare management reports on monthly basis (Demand Review Meeting, Monthly Performance Reviews and Core Commercial Cycles), variance analysis, risk & opportunities for management to review and drive business performance/gap closing initiatives and be the single point of contact for management reporting for that market
Prepare ad-hoc reporting requests from in-market finance teams or the FM e.g., trend analysis for a product type
Planowanie i przeprowadzanie efektywnych spotkań indywidualnych i grupowych z klientami, w oparciu o systematyczne pogłębianie o nich wiedzy, wdrażanie założeń modelu wizyty sprzedażowej i strategii promocyjnej, w celu maksymalizacji skuteczności przekazu informacji medycznych i kreowania właściwego wizerunku Haleon
Realizację celów firmowych poprzez działania informacyjne, promocyjneoraz wnikliwą analizę sytuacji biznesowej w obszarze dentystycznych wyrobów medycznych
Budowanie wizerunku firmy poprzez udział w targach i kongresach stomatologicznych
Skuteczne zarządzanie obsługiwanym terytorium poprzez stałą analizę potencjału klientów, uzyskiwanych rezultatów, działalności konkurencji i lokalnych uwarunkowań w celu optymalizacji dotarcia do grupy docelowej, wykorzystania zasobów i czasu pracy dla realizacji założonych celów
Rzetelne i terminowe planowanie oraz raportowanie aktywności i wyników oraz aktualizowanie baz danych, zgodnie z wymaganiami Haleon
Systematyczne aktualizowanie wiedzy o produktach, strategii promocyjnej, regulacjach prawnych oraz podnoszenie umiejętności komunikacyjnych, w celu zapewnienia najwyższej jakości przekazu informacji naukowej dla klientów firmy
Skuteczna współpraca z innymi przedstawicielami Haleon w zakresie wymiany informacji oraz prowadzenia wspólnych przedsięwzięć na poziomie regionu
Lead engineering of Data, Marketing and Social products (social channels, websites personalisation, audiences segmentation, analytics and decision engines) through technical solution design, implementation & continuous improvement processes
Works with 2-3 Scrum Teams, as well as internal and external stakeholders, to influence and drive technical standard, architecture and decision making and support organizational project or product teams
Contributes and aligns solutions to the MarTech roadmap, Target Architecture working closely with Enterprise Architects team
Adopt agile and DevOps principles
Ensure that technical delivery is fully compliant with GSK Security, Quality and Regulatory standards
Ensure use of relevant central enterprise services and collaborating with service partners in identification and delivery of service improvements
Support Product Owners and product teams to deliver value continuously, fostering and maintaining close links with customers, related Solution groups e.g. Global Therapy Areas, Marketing Operations Center (MOC), Design Center (DC) and Core Tech
Keep relevant technical documentation up to date in support of the lifecycle plan for audits/reviews
Pro-actively engage in experimentation and innovation to drive relentless improvement supporting product roadmaps
Provide leadership, technical direction and GSK expertise to product teams composed of GSK FTEs, strategic partners and software vendors
Contribute to release planning and roadmaps working closely with Product Owners and Product Director
Cross team delivery: Mastery of complex facilitation and dependency management techniques (cross team, cross department)
Implementation and maintenance of an effective QMS to ensure that local operations are in full compliance with GMP, GDP, local regulatory requirements for markets supported by the operation and GSK standards. QMS topics include, but are not limited to, management of SOPs, change control, product release, repacking, product quality complaints, deviations, incidents, CAPA, auditing, third party management, risk management etc
Maintaining the Agreement framework with the relevant GSK entities to support the Quality Hub operation
Objectives and KPI’s – support management of quality objectives & KPI’s
Quality Plans – support implementation of Annual Quality Plans
Work with supervision from Line Manager
Maintain a high level of QMS and local legislation knowledge and awareness of changes within the commercial environment
Support the development and implementation of processes within area of expertise
Gain an understanding of the Supply Chain, Commercial and Quality plans as they potentially link to day to day and quality improvement activities
Identify problems and support identification and implementation of process improvements
Regulatory Specialist, Annual Reporting, Site Registration and GMP team
Poznań
Wygasła: 19.09.2023
full-time
umowa o pracę
hybrid work
specialist (Mid / Regular)
Obowiązki:
take responsibility for planning, preparation, technical review, delivery and associated regulatory activities of CMC Annual Reports (for NDAs/BLAs/DMFs, Canadian Annual Notifications, Brazil and China ARs), Site/Facilities variations for GSK’s established product portfolio for both Pharma (Rx) and Vaccine (Vx) products,
work closely and provide CMC regulatory advice and guidance to CMCRA, Pharma Supply Chain (PSC), Local Operating Companies and Regions in order to produce high quality and timely documentation in support of Annual Reporting and Site/Facilities variations,
participate in the creation, improving and implementation of working practices and procedures aimed at simplifying processes and increasing quality,
monitor regulatory intelligence and act proactively on identified changes to regulatory requirements,
manage multiple projects/products simultaneously,
build and maintain good relationships with your internal and external stakeholders,
Regulatory Specialist, Annual Reporting, Site Registration and GMP team
Warszawa
Wygasła: 19.09.2023
full-time
umowa o pracę
hybrid work
specialist (Mid / Regular)
Obowiązki:
take responsibility for planning, preparation, technical review, delivery and associated regulatory activities of CMC Annual Reports (for NDAs/BLAs/DMFs, Canadian Annual Notifications, Brazil and China ARs), Site/Facilities variations for GSK’s established product portfolio for both Pharma (Rx) and Vaccine (Vx) products,
work closely and provide CMC regulatory advice and guidance to CMCRA, Pharma Supply Chain (PSC), Local Operating Companies and Regions in order to produce high quality and timely documentation in support of Annual Reporting and Site/Facilities variations,
participate in the creation, improving and implementation of working practices and procedures aimed at simplifying processes and increasing quality,
monitor regulatory intelligence and act proactively on identified changes to regulatory requirements,
manage multiple projects/products simultaneously,
build and maintain good relationships with your internal and external stakeholders,
Participation in development of the Company Core Datasheet (Global Product Information) for new medicines or product line extensions
Maintenance of country/regional labelling in compliance with GSK labelling processes and external requirements for local markets e. g. Europe (for Centralized, Mutual Recognition and Decentralized procedure submissions), US and International countries
Managing core and local prescribing/patient information throughout the product lifecycle
Working with colleagues in GSK Local Operating Companies in markets worldwide to ensure the company core datasheet is accurately reflected in local prescribing/patient information
Authoring responses to prescribing/patient information questions from Regulatory Authorities
Providing Local Operating Companies with required documents for national labelling submissions
Coordination of CTA/IND (Clinical Trials Applications/ Investigational New Drug submissions), to ensure timely delivery and ensuring the content is appropriate to each individual regulatory agency while maintaining compliance with GSK policy and procedures
Accountable to the functional CTA/IND Team Lead for overall work plans and to Global Regulatory Leads or Regional Representatives for definition of requirements within an agreed project
Accountability for agreed tasks and projects
Ensure independent communication, with a range of internal GSK staff, in support achievement of the assigned goals
Ensure compliance with GSK CTA/IND process through timely action and completion of records in internal GSK systems
Ensure quality of own work to agreed timeframes, including compliance with GSK systems and record keeping
Coordination of CTA/IND (Clinical Trials Applications/ Investigational New Drug submissions), to ensure timely delivery and ensuring the content is appropriate to each individual regulatory agency while maintaining compliance with GSK policy and procedures
Accountable to the functional CTA/IND Team Lead for overall work plans and to Global Regulatory Leads or Regional Representatives for definition of requirements within an agreed project
Accountability for agreed tasks and projects
Ensure independent communication, with a range of internal GSK staff, in support achievement of the assigned goals
Ensure compliance with GSK CTA/IND process through timely action and completion of records in internal GSK systems
Ensure quality of own work to agreed timeframes, including compliance with GSK systems and record keeping
Primarily responsible for the delivery of SMAS (Specialised Management Accounting Services) processes according to agreed operating model and/or Service Level Agreements whilst ensuring full compliance with GSK and external accounting policies
Operate according to governance frameworks, policies and internal controls (SOX /Audit), prepare reconciliations for Balance Sheet accounts in scope as well as other relevant accounting controls
Ensure that Site Actuals are accounted for and reported in an accurate and timely fashion for the assigned processes to support reliable, informed business decisions
Align and partner with Site Finance to review results against plans and identify improvement opportunities
Communicate and present information in a way that stakeholders can easily visualize and understand it to evaluate performance, exploit business opportunities or manage risk
Build strong working relationships with customer groups and stakeholders, manage stakeholder expectations and needs, communicate effectively in all interactions through various means
To manage own time appropriately to ensure assigned processes are performed and delivered in line with agreed timelines, and according to standard work approach
Seek development and improvement, to deliver a level of expertise in assigned process to the benefit of SMAS group and site customers
To actively support the SMAS culture of continuous improvement within the cluster and across the SMAS, striving for standardization and improved performance to support delivery of wider organizational objectives
Global Products & Technology meet the need for clear, accurate, and timely financial and business information, leads appropriately – participates in a regular structured commercial performance review, supervises alignment with agreed contracts, raises any related risks, issues ensuring accurate escalations
Design models and methodologies for future cost modeling and business decisions support; support business in planning and forecasting periodic activities/trend
Prepare and publish reports to partners to show costing progress - track financials, and handle operational budgets. Provide explanations for differences from expectation
Provide financial analysis expertise and insight into the development of strategies
Ensure that commercial transactions are run optimally and in a timely manner - this includes ensuring purchase orders, cross-charging, payments, etc., are all executed correctly and issues are addressed
Agree and document correct accounting for new R&D alliances and licensing contracts
For financial approval papers for new R&D contracts, coordinate inputs and approvals from External Reporting, Tax and Treasury
Overall financial management of venture capital investment funds and equity investments
Participate in month-end review of R&D alliance related journals, balance sheet reconciliations, commentary and Sarbanes Oxley control responsibilities
Participate in review of UK annual statutory accounts
Partnering with external alliance partners, internal and external auditors
Managing relationships with multiple finance and business stakeholders
Ensuring timely delivery of monthly and quarterly reporting
Ensuring full compliance with IFRS and SOX requirements
Product release -review of transit temperature data prior to distributor release for sale
Complaints –clear link to adverse event reporting and local product incident process for markets in scope of the operation
Incidents management - manage according to local timelines and communicate any product quality related issues
Recalls –oversee a market recall, enacted through the in-market distributor
Change control –manage all planned quality related changes including new product introduction, product discontinuation, major pack changes, re-packing activities. Review progress of changes and close out when completed
Deviation –investigate deviations and develop CAPAS’s
Corrective and preventive action (CAPA) –manage corrective and preventive actions. Ensure that effectiveness check is performed for CAPA’s
Imperfect deliveries / Distribution incidents –oversight of transportation damages, missing or non-conforming temperature data, and hidden quality defects from the distribution chain or manufacturing site
Risk Management –manage and escalate quality risks
Periodic Product Review –MAH responsibilities for Periodic Product Review requirements as per market requirements
Auditing –management monitoring level 1 (self-inspection) and internal business monitoring level 2 auditing; new and existing GxP 3rd party contractors are identified, qualified and audited; the Hub is audit ready for any relevant internal audit
Quality Council/Management Review – in place with regular meeting aligned with Partner Markets, including all relevant business functions
Maintaining the Supply Agreement framework to support the supply of quality product
Objectives and KPI’s – Identify, Implement and Manage QA Objectives & KPI’s
Quality Plans – Establish and manage Annual Quality Plans
Be the first line customer management with full scope of customer services for CIS-DNP Kazakhstan (Kz) market. Support the monthly CCC (S&OP) cycle and development of the forward market forecast
Own and drive KPIs and deliver optimized customer service, product availability, end-to-end P&L budget management and cost-to-serve by initiating and running projects/programmes aligned with the Regional partners
Actively lead delivery of other end-to-end Supply Chain & Business KPIs for Kz, such as Forecast Accuracy, Bias, Inventory, Inventory Write-offs etc
Act as the coordinating point for Demand & Supply team members supporting the Demand Review Meeting (DRM) process and Supply review processes
Provide maintenance of critical market system supported processes and also provide further interface and efficient collaboration between Commercial and other functions (e.g. Demand, Supply Planning, Compliance, Regulatory, Quality and Pharma Logistics etc):
Manage supply of customer orders with internal; and external partners and respond to resolving operational issues
Lead preparation of budget files and keep cost under control for full end-to-end supply chain from sites to customers via the Multi-Market Warehouse (MMW); continuous improvement and Cost to Serve targets achievement
Where required, take a lead role for Logistics Service Providers selection via bid process and contractual decisions (rates/service agreement) ensuring the route to market remains optimal
Manage Service Providers and assess the quality of services provided, create and maintain service level agreements (SLA) with logistics partners
Manage processes, standardization of tools and setting governance for leading alignment cross-functionally and cross-regionally
Develop recommendations and implementation strategy in distribution, transportation, planning and warehousing of company products
Ensure C&C support provided to respective Finance teams is fully compliant with all relevant standards, current best practices, procedures/policies, and SLA
Work proactively to integrate and drive efficient processes in support of reporting & costs analysis
Ensure business complies with all aspects of the internal/external financial control environment, including published accounting papers and policies
Support and is responsible for the inputs to the external and internal financial audits
Manage all aspects of the financial month-end process, including OPEX and Headcount reporting requirements, facilitating month-end meetings, coordinating with all involved partners
Manage Master Data requests (coordination, approval, etc.)
Contribute to the reporting of financial results for commercial entities under responsibility with commentary including income, balance sheet and cash flow; responsible for smaller entities
Perform month end close activities
Support Finance Controller with business performance analyses related to Sales and Opex
Cooperate with Local Financial Team, present & discuss outcomes of financial analyses
Manage Operating Expenditure and all reporting requirements
Ensure entities results are fully compliant with internal controls and relevant accounting standards, current best practice and any other regulations
Contribute to the reporting of financial results for commercial entities under responsibility with commentary including income, balance sheet and cash flow; responsible for smaller entities
Perform month end close activities
Support Finance Controller with business performance analyses related to Sales and Opex
Cooperate with Local Financial Team, present & discuss outcomes of financial analyses
Manage Operating Expenditure and all reporting requirements
Ensure entities results are fully compliant with internal controls and relevant accounting standards, current best practice and any other regulations
Act as bridge between Lean Portfolio Management, Business Operations, and Tech Finance ensuring technology solutions and business processes are aligned to GP&T standards
Facilitate GP&T’s needs for clear, accurate, and timely financial and business information on investment and ongoing projects, bringing closer synergy to financial standards and processes
Contribute to defining GP&T Financial Management standards, processes, operational procedures and create training materials for end-user population
Look for reporting efficiencies while defining financial standards and processes, automate where possible
Support Portfolio and Project Managers with financial queries, processes, purchase order creation in partnership w/ Lean Portfolio Management, Business Operations, and Tech Finance
Prepare financial budgets, forecasts, tracking, reconciliations, and rationale of expectation/trend deltas
Conduct user elicitation and support business case development of GP&T strategies
Przygotowywanie dokumentacji z zakresu modułu 3 CTD dotyczących zmian porejestracyjnych dla substancji czynnych, półproduktów i produktów gotowych, w tym również produktów biologicznych oraz szczepionek
Uzgadnianie strategii rejestracyjnej, ocena dokumentacji i danych pod kątem zgodności z wewnętrznymi wymaganiami GSK oraz prawem obowiązującym w danym kraju
Współpraca z innymi zespołami GSK: fabryki, łańcuch dostaw, zespoły lokalne na całym świecie
Budowanie i utrzymywanie dobrych relacji z partnerami
Represent CSQA and participate in the review and approval of computer system documentation throughout the lifecycle of an application
Review and approval of change requests through to closure of computerized systems and infrastructure as applicable
May interact with regulators during regulatory inspections and provide relevant documentation as required
Support/Manage routine computer compliance audits (internal & external) as well as computer compliance initiatives
Identify computer related business, regulatory or reputational risks associated with job responsibilities and communicate these upward along with suggestions for risk management solutions
Establish improvement processes, as needed, or set specific measurable targets and goals linked to CSQA/GQA/GSK business needs
Contribute to or lead the training, education, guidance and influencing of GSK R&D staff on best quality and computer compliance policy and practices
Identify and mitigate computer compliance risks to GSK through effective audits and/or via providing advice and consultancy to GQA and business units regionally and globally
Proactively identify, communicate, and monitor business and/or regulatory changes that could impact on quality or compliance within and across departments
Any other duties relevant to, and consistent with, the level of responsibility of the job, as required by CSQA management
Managing and supervising Controls Testing Plans delivered by our third-party supplier, which includes reviewing controls testing results, and communicating significant issues and areas of exposure to local management and Finance Directors
Managing senior stakeholders very closely regarding risk management and controls and drive a proactive risk mindset in the organization
Performing end-to-end process risk assessments and control deficiencies analysis to identify high areas of exposure, support in root cause analysis and investigation, review and align with the business on remediation plans and actions to reduce risks or resolve deficiencies
Provide Risk management expertise on remediation activities related to control deficiencies and/or process gaps to ensure adequate risk mitigation
Advise on risk management and controls impact to projects and/or continuous improvement initiatives led by the global process tower organization and/or Process Improvement Experts in Global Finance Services (GFS) organization and / or the regional hub leadership team
Support and engage with external audit, and other external or internal bodies in risk and control issues to reduce impact to business, increase reliance, and align on auditor’s assessment of the finance control environment for SOX reporting purposes
Collaborating across the regions to inform and gather intelligence on risks and controls
Przygotowywanie dokumentacji z zakresu modułu 3 CTD dotyczących zmian porejestracyjnych dla substancji czynnych, półproduktów i produktów gotowych, w tym również produktów biologicznych oraz szczepionek
Uzgadnianie strategii rejestracyjnej, ocena dokumentacji i danych pod kątem zgodności z wewnętrznymi wymaganiami GSK oraz prawem obowiązującym w danym kraju
Współpraca z innymi zespołami GSK: fabryki, łańcuch dostaw, zespoły lokalne na całym świecie
Budowanie i utrzymywanie dobrych relacji z partnerami
Managing multiple CMC (Chemistry, Manufacturing and Control) Variations and source transfers for Finished Products and Active Pharmaceutical Ingredients for Pharma and Vaccines products
Managing routine assigned projects: define and agree regulatory strategy, complete data assessment to ensure authored regulatory dossier is in compliance with GlaxoSmithKline regulatory processes and external requirements for local markets e.g. Europe (for Centralised, Mutual Recognition and Decentralised procedure submissions), US and International countries
Working with colleagues in Global Manufacturing & Supply, Global Regulatory Groups and GSK Local Operating Companies in markets worldwide to deliver high quality dossiers on time
Building and maintaining good relationships with internal and external stakeholders
Monitoring regulatory intelligence and acting proactively on identified changes to the regulatory requirements
Identifying the improvement opportunities for CMC Regulatory processes, policies and systems
Managing multiple CMC (Chemistry, Manufacturing and Control) Variations and source transfers for Finished Products and Active Pharmaceutical Ingredients for Pharma and Vaccines products
Managing routine assigned projects: define and agree regulatory strategy, complete data assessment to ensure authored regulatory dossier is in compliance with GlaxoSmithKline regulatory processes and external requirements for local markets e.g. Europe (for Centralised, Mutual Recognition and Decentralised procedure submissions), US and International countries
Working with colleagues in Global Manufacturing & Supply, Global Regulatory Groups and GSK Local Operating Companies in markets worldwide to deliver high quality dossiers on time
Building and maintaining good relationships with internal and external stakeholders
Monitoring regulatory intelligence and acting proactively on identified changes to the regulatory requirements
Identifying the improvement opportunities for CMC Regulatory processes, policies and systems
Manage reporting processes for GSK entities to support monitoring of compliance with internal policies/processes and external regulations of contracts with and payments to external experts, healthcare professionals and healthcare related organizations
Ensure accuracy, completeness, timeliness and reconciliation of data between multiple systems and databases
Provide internal customer support as needed to facilitate the analysis during the conduct of business
Interact with other areas within and outside GSK in support of business transactions and to coordinate efforts across internal and external areas
Maintain database of payments and supplemental information to meet all state reporting, regulatory and management reporting requirements
Identify, recommend and assist in the implementation of continuous improvement initiatives
Provide historical information on transactions in support of requests from the Legal and Compliance departments of GSK
Business understanding: Working with other software developers and data engineers, you are expected to understand the business context, systems, environment, strategy, and people aligned to the given area. You should be able to translate a business problem into a software engineering problem
Team collaboration: In this role you will be accountable for your own user stories within a product team’s backlog for the technical solution design, implementation & continuous improvement of Supply Chain Digital & Tech solutions in alignment with agile and DevOps principles, working closely with a Group of Tech Engineers and a Product Owner
Software delivery: As part of the team’s delivery, you will participate in requirements analysis and build user-facing solutions using Azure cloud services and GSK data platforms. The expectation is to produce well-engineered software meeting end-user needs while following coding best practices and ways of working, participating in code reviews, and partnering to improve the team's standards
Personal development: You should be ready to keep learning and using your skills to design and test innovative solutions, both in integration, backend, data exchange or UI. We would like you to stay ready to learn and adapt to new technologies, with commitment towards personal development