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Senior Product Manager
Warszawa
Wygasła: 10.03.2024
full-time
umowa o pracę
hybrid work
senior specialist (Senior)
Obowiązki:
Implementation & execution of the marketing strategy for the brands in scope delivering the annual business plan & P&L assumptions
Development & implementation of comprehensive strategies and brand activation plans with cross-functional teams to drive brand performance (sales value & market shares)
Lead the development of core promotional assets for HCP promotion aligned to brand strategy
People management and cross-functional co-operation with other departments (medical, sales, financial, market access and regulatory departments) to develop comprehensive strategies and brand account plans to drive brand performance (sales value & market shares)
Close cooperation with EEs in the field
Accountability for excellent launch new products in portfolio
Preparation of recommendation for brand portfolio strategy, pricing strategy
Providing with training of sales force for the promoted brands in scope, preparing promo communication & materials
Ensuring proper forecasting and supply management for brands in scope
Responsibility for brand’s P&L and annual budgeting
Driving innovation in digital marketing strategies by implanting local projects and coordination of global initiatives (DDCX). Be a champion for and create an exceptional multichannel customer experience for ViiV’s brands to maximize potential in the marketplace
Preparing and coordinating monthly business review meetings with local and regional executive teams
Develop and action on deep insights generated in market research
Implementation & execution of the marketing strategy for the brands in scope delivering the annual business plan & P&L assumptions – this includes EE engagement and pricing strategies
Development & implementation of comprehensive strategies and brand activation plans with cross-functional teams to drive brand performance (sales value & market shares)
Cross-functional co-operation with other departments (medical, sales, financial, market access and regulatory departments) to develop comprehensive strategies and brand account plans in order to drive brand performance (sales value & market shares)
Accountability for excellent launch and reimbursement process for Nucala New Indications
Preparation of recommendation for brand portfolio strategy, pricing strategy
Providing with training of sales force for the promoted brands in scope, preparing promo communication & materials
Ensuring proper forecasting and supply management for brands in scope
Responsibility for brand’s P&L and annual budgeting
Driving innovation in digital marketing strategies by implanting local projects and coordination of global initiatives (DDCX)
Preparing and coordinating monthly business review meetings with local and regional executive teams
Leads the local study team consisting of within-country clinical operations team members, cross-functional experts (medical, regulatory, supply logistics, finance, legal, etc.), vendor staff and external clinical site staff involved in study preparation and delivery; providing both matrix leadership and project mangement of study activities within the countr(ies)
Accountable for within-countr(ies) delivery of assigned studies to time, budget and quality expectations as defined in the clinical development plan and study protocol as well as in local regulations, IND/GCP/ICH-guidelines, GSK Corporate, Vaccines, and local SOPS and POLs
Demonstrates the ability to effectively manage multiple priorities and responsibilities of increased scope and complexity
Ensures that critical study timelines related to study activities within-countr(ies) are accurately forecasted and achieved and that recruitment targets, patient recruitment cycle times, data and audit quality are met. Provides trouble-shooting and problem resolution support for within-country study team to ensure productive, efficient study delivery
Identifies and resolves or escalates issues and risks that may impact study delivery.Takes a leadership role in identifiying the root cause of issues, implementing/influencing corrective and preventative actions locally or at a broader study level
Has the accountability to estimate, track and deliver against the local budget for the studies within their scope of responsibility
As required, advises on contract development with Sites/CRO/Vendors and may participate in budget/contract negotiations with study vendors or clinical investigator sites
As required, prepares the local Informed Consent Form and coordinates the submission of the Clinical Study Application to Regulatory Authority (RA) and local Ethics Committees (ECs). Maintains communication with RA and ECs to ensure all regulatory requirements are met in a timely manner throughout the study
Takes a leadership role in standardizing processes within and across countries, identifying and sharing best practices in support of continuous improvement. Represents local/regional clinical operations on global and cross functional initiatives. May serve in a subject matter expert (SME) capacity locally/globally
Continuously develops knowledge in the areas of GCP, internal company guidelines, SOPs, new monitoring, site and project management skills and capabilities. Serves as an expert in ICH GCP and GSK written standards for LDLs
Available and willing to travel as job requires (approx.15%)
Menedżer ds Kluczowych Klientów odpowiada za promocję naszego produktu pulmonologicznego na przydzielonym terenie (Łódź)
Zwiększenie sprzedaży portfolia leków na ciężką astmę eozynofilową (SEA) poprzez skuteczne informowanie o wartościach oraz właściwym stosowaniu mepolizumabu
Promowanie wartości produktów GSK (SEA) wśród docelowych pracowników służby zdrowia, w tym między innymi lekarzy szpitalnych, pielęgniarek, farmaceutów, lokalnych płatników oraz wszelkich innych odpowiednich interesariuszy mających wpływ na przepisywanie leków GSK
Opracowywanie i realizacja planów kont dla danego terytorium we współpracy z innymi działami wewnętrznymi GSK
Budowanie i utrzymywanie produktywnych, profesjonalnych relacji z klientami i interesariuszami w celu zapewnienia pomyślnej promocji terapii GSK
Współpraca ze wszystkimi funkcjami, aby zapewnić udane wprowadzenie na rynek i/lub ciągłą promocję produktów GSK
Transparentna komunikacja i terminowe informacje zwrotne z Kierownikiem liniowym i współpracownikami z różnych funkcji na temat wyników dyskusji i bieżących zmian na rynku
Zarządzanie budżetem; planowanie wydatków w związku z organizowanymi wydarzeniami oraz spotkaniami i inne koszty na danym terytorium, wykorzystując dostępne zasoby, aby realizować działania, które zwiększają zwrot z inwestycji i duży wpływ
Leads the local study team consisting of within-country clinical operations team members, cross-functional experts (medical, regulatory, supply logistics, finance, legal, etc.), vendor staff and external clinical site staff involved in study preparation and delivery; providing both matrix leadership and project mangement of study activities within the countr(ies)
Accountable for within-countr(ies) delivery of assigned studies to time, budget and quality expectations as defined in the clinical development plan and study protocol as well as in local regulations, IND/GCP/ICH-guidelines, GSK Corporate, Vaccines, and local SOPS and POLs
Demonstrates the ability to effectively manage multiple priorities and responsibilities of increased scope and complexity
Ensures that critical study timelines related to study activities within-countr(ies) are accurately forecasted and achieved and that recruitment targets, patient recruitment cycle times, data and audit quality are met. Provides trouble-shooting and problem resolution support for within-country study team to ensure productive, efficient study delivery
Identifies and resolves or escalates issues and risks that may impact study delivery.Takes a leadership role in identifiying the root cause of issues, implementing/influencing corrective and preventative actions locally or at a broader study level
Has the accountability to estimate, track and deliver against the local budget for the studies within their scope of responsibility
As required, advises on contract development with Sites/CRO/Vendors and may participate in budget/contract negotiations with study vendors or clinical investigator sites
As required, prepares the local Informed Consent Form and coordinates the submission of the Clinical Study Application to Regulatory Authority (RA) and local Ethics Committees (ECs). Maintains communication with RA and ECs to ensure all regulatory requirements are met in a timely manner throughout the study
Takes a leadership role in standardizing processes within and across countries, identifying and sharing best practices in support of continuous improvement. Represents local/regional clinical operations on global and cross functional initiatives. May serve in a subject matter expert (SME) capacity locally/globally
Continuously develops knowledge in the areas of GCP, internal company guidelines, SOPs, new monitoring, site and project management skills and capabilities. Serves as an expert in ICH GCP and GSK written standards for LDLs
Available and willing to travel as job requires (approx.15%)
Responsible for determining the most appropriate submissions strategy for the study in collaboration with study team. Provides consult to the study team to ensure best possible outcome for regulatory and/or ethics committee submissions
Accountable for the timely delivery of local regulatory and/or ethics submission content in collaboration with local and central study teams and global/local regulatory team if applicable
Responsible for the preparation, collation, review, tracking and filing of all documentation required for regulatory and/or ethics committee submissions. This may include Informed Consent form review, coordinating translations, preparation of central/national ethics submissions, delivery of documents to sites for local ethics committee submissions. As needed, coordinates the support of Clinical Support Specialists in preparation, tracking system updates and filing of documents
Maintains communication with Regulatory Affairs/Minister of Health contacts, National/Central Ethics Committee, and sites to ensure all submission requirements are met in timely manner throughout the study
Connects with local internal and external experts to keep up to date with changes in regulations or submission requirements. Learns from past submission outcomes and continually improves future submissions. Where applicable, become an active member in local external think tanks, bodies, agencies to support the local simplification and/or acceleration of regulatory and/or ethics committee submission process
Associate Director - Start Up and Operations Manager
Poznań
Wygasła: 02.06.2023
full-time
umowa o pracę
hybrid work
team manager
Obowiązki:
Accountable to lead the Local Clinical Operations Specialists to ensure timely Start Up, operational management, completion and delivery of all clinical studies across multiple therapeutic areas to agreed start up timelines according to UQ (Upper Quartile), budget and quality target working according Country regulations, GSK SOPs and GCP
Accountable for maintaining internal tracking for study site status from initial site contact through site initiation and maintains clear internal team communication and documentation
Accountable for line and performance management of Team Members: conduct regular 1:1 meeting, develop staff competencies and identify skill gaps. Arranges appropriate training to ensure they have the skills and knowledge required. Utilizes coaching and mentoring strategy to enhance individual and overall team performance
Accountable through the Clinical Operations Specialist and through collaboration with key stakeholders (Legal, Data Privacy Office, Procurement, Regulatory) that all Clinical Trial contracts are well managed through the Fair Market Value approach as proposed study by study by GSK Central Teams as well as through the integration of GSK Global / Local legal contract prerequisites
Responsible for standardizing processes, identifying, and sharing best practices and representing his/her team on internal and cross functional process improvement teams
Responsible for resource management and allocation to maintain business performance and a sustainable workload
Consulted for the LOC CRO’s oversight (operational aspects) when studies are delivered through the FSO (Fully Study Outsourced) Model
Responsible for study archiving on the country level
Represent GSK in key events (i.e Forum, Symposium, Trade Association, etc) and discussion related to the development of clinical research activities / investigator partnerships
Is the point of contact for the FSP CRO CTC Line Manager in charge of study management through the FSP (Full-Service Provider) model, providing / capturing regular feedback for assuring study delivery and sharing best practice
Accountable for managing locally all clinical operational aspects related the Regulatory Vault approach
Responsible for overseeing/managing staff resource utilization across the department in collaboration with FSP Managers
Responsible for managing Third Party Vendors performance
Keeping track on GMASE/department and CRO metrics and making appropriate recommendation to the LT to ensure continued improvement
Associate Director - Start Up and Operations Manager
Warszawa
Wygasła: 02.06.2023
full-time
umowa o pracę
hybrid work
team manager
Obowiązki:
Accountable to lead the Local Clinical Operations Specialists to ensure timely Start Up, operational management, completion and delivery of all clinical studies across multiple therapeutic areas to agreed start up timelines according to UQ (Upper Quartile), budget and quality target working according Country regulations, GSK SOPs and GCP
Accountable for maintaining internal tracking for study site status from initial site contact through site initiation and maintains clear internal team communication and documentation
Accountable for line and performance management of Team Members: conduct regular 1:1 meeting, develop staff competencies and identify skill gaps. Arranges appropriate training to ensure they have the skills and knowledge required. Utilizes coaching and mentoring strategy to enhance individual and overall team performance
Accountable through the Clinical Operations Specialist and through collaboration with key stakeholders (Legal, Data Privacy Office, Procurement, Regulatory) that all Clinical Trial contracts are well managed through the Fair Market Value approach as proposed study by study by GSK Central Teams as well as through the integration of GSK Global / Local legal contract prerequisites
Responsible for standardizing processes, identifying, and sharing best practices and representing his/her team on internal and cross functional process improvement teams
Responsible for resource management and allocation to maintain business performance and a sustainable workload
Consulted for the LOC CRO’s oversight (operational aspects) when studies are delivered through the FSO (Fully Study Outsourced) Model
Responsible for study archiving on the country level
Represent GSK in key events (i.e Forum, Symposium, Trade Association, etc) and discussion related to the development of clinical research activities / investigator partnerships
Is the point of contact for the FSP CRO CTC Line Manager in charge of study management through the FSP (Full-Service Provider) model, providing / capturing regular feedback for assuring study delivery and sharing best practice
Accountable for managing locally all clinical operational aspects related the Regulatory Vault approach
Responsible for overseeing/managing staff resource utilization across the department in collaboration with FSP Managers
Responsible for managing Third Party Vendors performance
Keeping track on GMASE/department and CRO metrics and making appropriate recommendation to the LT to ensure continued improvement
Zwiększenie sprzedaży portfolia leków na ciężką astmę eozynofilową (SEA) poprzez skuteczne informowanie o wartościach oraz właściwym stosowaniu mepolizumabu
Promowanie wartości produktów GSK (SEA) wśród docelowych pracowników służby zdrowia, w tym między innymi lekarzy szpitalnych, pielęgniarek, farmaceutów, lokalnych płatników oraz wszelkich innych odpowiednich interesariuszy mających wpływ na przepisywanie leków GSK
Opracowywanie i realizacja planów kont dla danego terytorium we współpracy z innymi działami wewnętrznymi GSK
Budowanie i utrzymywanie produktywnych, profesjonalnych relacji z klientami i interesariuszami w celu zapewnienia pomyślnej promocji terapii GSK
Współpraca ze wszystkimi funkcjami, aby zapewnić udane wprowadzenie na rynek i/lub ciągłą promocję produktów GSK
Transparentna komunikacja i terminowe informacje zwrotne z Kierownikiem liniowym i współpracownikami z różnych funkcji na temat wyników dyskusji i bieżących zmian na rynku
Zarządzanie budżetem; planowanie wydatków w związku z organizowanymi wydarzeniami oraz spotkaniami i inne koszty na danym terytorium, wykorzystując dostępne zasoby, aby realizować działania, które zwiększają zwrot z inwestycji i duży wpływ
Zwiększenie sprzedaży portfolia leków na ciężką astmę eozynofilową (SEA) poprzez skuteczne informowanie o wartościach oraz właściwym stosowaniu mepolizumabu
Promowanie wartości produktów GSK (SEA) wśród docelowych pracowników służby zdrowia, w tym między innymi lekarzy szpitalnych, pielęgniarek, farmaceutów, lokalnych płatników oraz wszelkich innych odpowiednich interesariuszy mających wpływ na przepisywanie leków GSK
Opracowywanie i realizacja planów kont dla danego terytorium we współpracy z innymi działami wewnętrznymi GSK
Budowanie i utrzymywanie produktywnych, profesjonalnych relacji z klientami i interesariuszami w celu zapewnienia pomyślnej promocji terapii GSK
Współpraca ze wszystkimi funkcjami, aby zapewnić udane wprowadzenie na rynek i/lub ciągłą promocję produktów GSK
Transparentna komunikacja i terminowe informacje zwrotne z Kierownikiem liniowym i współpracownikami z różnych funkcji na temat wyników dyskusji i bieżących zmian na rynku
Zarządzanie budżetem; planowanie wydatków w związku z organizowanymi wydarzeniami oraz spotkaniami i inne koszty na danym terytorium, wykorzystując dostępne zasoby, aby realizować działania, które zwiększają zwrot z inwestycji i duży wpływ
Wysoko rozwinięte umiejętności sprzedażowe – umiejętność zaangażowania klienta poprzez zrozumienie potrzeb jego pacjentów, merytoryczną i bazującą na argumentach medycznych dyskusję
Doświadczenie w pracy z klientem instytucjonalnym – budowanie strategicznych sojuszy opartych na doskonałym zrozumieniu potrzeb klienta (współpraca win- win)
Sprzedaż wielokanałowa – zapewnienie doskonałego doświadczenia klienta poprzez dopasowanie narzędzi sprzedażowych do jego potrzeb. Umiejętność skutecznego wykorzystania narzędzi cyfrowych
Analiza i przygotowanie planów terytorialnych, poszukiwanie szans do rozwoju a także wczesna identyfikacja i adresowanie wyzwań. Budowanie list targetowych w oparciu o aktualną wiedzę rynkową
Umiejętność zarządzania terytorium bazująca na zrozumieniu i analizie danych rynkowych i insightu
Systematyczne aktualizowanie wiedzy o produktach, wynikach badań klinicznych, strategii promocyjne
Skuteczna współpraca z innymi działami i przedstawicielami GSK VBU
Działanie w pełni zgodne z obowiązującymi procedurami
Leads the local study team consisting of within-country clinical operations team members, cross-functional experts (medical, regulatory, supply logistics, finance, legal, etc.), vendor staff and external clinical site staff involved in study preparation and delivery; providing both matrix leadership and project mangement of study activities within the countr(ies)
Accountable for within-countr(ies) delivery of assigned studies to time, budget and quality expectations as defined in the clinical development plan and study protocol as well as in local regulations, IND/GCP/ICH-guidelines, GSK Corporate, Vaccines, and local SOPS and POLs
Demonstrates the ability to effectively manage multiple priorities and responsibilities of increased scope and complexity
Ensures that critical study timelines related to study activities within-countr(ies) are accurately forecasted and achieved and that recruitment targets, patient recruitment cycle times, data and audit quality are met. Provides trouble-shooting and problem resolution support for within-country study team to ensure productive, efficient study delivery
Identifies and resolves or escalates issues and risks that may impact study delivery.Takes a leadership role in identifiying the root cause of issues, implementing/influencing corrective and preventative actions locally or at a broader study level
Has the accountability to estimate, track and deliver against the local budget for the studies within their scope of responsibility
As required, advises on contract development with Sites/CRO/Vendors and may participate in budget/contract negotiations with study vendors or clinical investigator sites
As required, prepares the local Informed Consent Form and coordinates the submission of the Clinical Study Application to Regulatory Authority (RA) and local Ethics Committees (ECs). Maintains communication with RA and ECs to ensure all regulatory requirements are met in a timely manner throughout the study
Takes a leadership role in standardizing processes within and across countries, identifying and sharing best practices in support of continuous improvement. Represents local/regional clinical operations on global and cross functional initiatives. May serve in a subject matter expert (SME) capacity locally/globally
Continuously develops knowledge in the areas of GCP, internal company guidelines, SOPs, new monitoring, site and project management skills and capabilities. Serves as an expert in ICH GCP and GSK written standards for LDLs
Available and willing to travel as job requires (approx. 15%)
Works with study teams (e.g. Medical Reviewer, Safety Reviewer, Central Monitoring Lead) on defining adequate analytical solutions within and outside of already existing tools to enable medical data analytics capability for Clin Ops, Safety, and Medical functions
Leads teams and networks across functional, geographical and cultural boundaries; leads by example and promotes collaboration, effective communication and leadership in others
Directs and makes decision on outsourcing transactional activities to GSK FSP service providers including forecasting budget implications
Leads the planning, prioritization and execution of multiple study support activities, including approval of plans, to deliver all required outputs
Acts as an expert representing department or programming function on departmental initiatives providing input and influencing groups outside of own discipline
Provide strong all-round technical competency in key areas of project delivery
Be accountable for named supplier(s)/category(ies) for risk and issue escalations for GCO/Development
Work with relevant contacts at supplier to ensure emergent risks and issues are addressed appropriately and within established timelines
Maintain ongoing control of identified risks by working with Global Risk Management to develop relevant Management Monitoring checks
Be accountable person for Clinical Quality Assurance supplier level audit findings. Identify and lead matrix team to develop and implement appropriate Corrective and Preventative Action responses including robust root cause and impact analysis
Work in a matrix manner with GCO/Development business contacts and to ensure robust holistic oversight (e.g. Risk Due Diligence, Technical Qualification, Full Service Outsourcing Delivery Lead, Clinical Research Organization Performance & Optimization, Clinical Study Teams, Digital Analytics & Performance, Global Monitoring and Site Engagement, Functional Leads, Procurement, etc.)
Review relevant dashboard data to identify trends
Work with Senior GSK and Vendor representatives to determine process landscape and required trainings for vendor staff. Ensure details are current and fit-for-purpose and rolled out as appropriate to support study teams with oversight requirements (e.g. SOP lists, trainings required, Tech systems utilized, etc.)
Establish periodic partnership review meetings with appropriate level personnel at named supplier to maintain health of relationship