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Creative Director (m/w/d)
empiricus GmbH - Agentur für IT Experten & Executives, Dreieich, Hessen
Creative Director Zukunft denken und Menschen mit Unternehmen rund um das Thema "Haus & Wohnen" verbindenWir suchen aktuell: Creative Director (m/w/d) in Dreieich Gehalt: bis 85.000 EURBeginn: nach VereinbarungDauer: FestanstellungStandort: Dreieich in Verbindung mit Home-Office-FlexibilitätAls Creative Director arbeiten Sie für eine große deutsche Einkaufskooperation. Zur Unternehmensgruppe gehören bekannte Marken sowie spezialisierte Dienstleistungsunternehmen für Marketing, Informationstechnologie, Betriebsführung und Finanzen.Ihre Aufgaben Sie leisten als Kreativ- und Designprofi Ihren Beitrag für eine erfolgreiche Entwicklung und Umsetzung von medienübergreifenden Ideen und Konzepten mit Award-Potential entlang der gesamten Customer JourneySie sind Impulsgeber und entwickeln die Kreativprozesse von der Idee bis zur Umsetzung von On-/Offline-KampagnenSie meistern gemeinsam mit Ihrem Team das Daily Business aus Art Direktoren, UX Designern, Entwicklern, Video und Reinzeichnern und sind verantwortlich für Ressourcen und BudgetIhr Blick auf unsere Marken umfasst On-/Offline-Medien (Website, Apps, Banner, Newsletter, sämtliche Printmedien, sowie sonstige Gestaltungsobjekte im Event und Video Bereich)Sie stehen nicht nur mit fachlichem Rat zur Seite, sondern sind der erste Ansprechpartner, wenn es brenntIhr ProfilSie haben ein Studiumsabschluss oder eine vergleichbare Qualifikation mit einschlägiger Berufserfahrung gepaart mit Kreativität und Neugierde sowie erste Awards gewonnenSie haben mindestens 10 Jahre in einer Kreativ- oder Marketingagentur gearbeitet und Erfahrung in Teamführung & -entwicklungSie haben ein gutes Kundengespür und einen hohen Anspruch an Ihre eigene Kreation.Sie prägt eine starke konzeptionelle Denkweise und arbeiten strukturiert und zielorientiertSie haben eine Leidenschaft für ideengetriebene und kreative Kreation über alle KanäleSie können sich für erklärungsbedürftige Produkte von B2C bis B2B-Kommunikation begeisternSie haben Spaß an offener und serviceorientierter Kommunikation mit Kunden und ein Bewusstsein für digitale Medien und sich entwickelnde Online-PlattformenSie bringen strategisches Denken gepaart mit Ideen, Kreativität sowie Gespür für die neusten Trends und Medienformate mitOn-/Offline- und Social-Media-Affinität sind für Sie selbstverständlichSie sind sicher in der gesamten Adobe Creative Suite (Photoshop, InDesign, Illustrator, After Effects, Premiere) und MS365, sowie haben Erfahrung in UX/UI Sie haben ein Gespür für Ästhetik und Farben, Form- und RaumgefühlIhre Deutschkenntnisse sind sehr gutWir finden diese Position klasse, weil...Sie bis zu 3 Tage im Home-Office arbeiten könnenSie in einem cross-funktionalen Team arbeiten und auf agile Methoden in der tägl. Arbeit setzenSie durch individuelle Unterstützung und Förderung sowie durch Impulse Ihrer Führungskraft sich weiterentwickeln könnenSie in einem wertschätzenden und modern ausgestatteten Team arbeitenOh? Die Position passt doch gar nicht!Vereinbaren Sie ein unverbindliches Beratungsgespräch mit uns oder bewerben sich online initiativ. Wenn wir Ihre persönlichen Bedürfnisse und Karriereziele genau kennen, finden wir für Sie einen Job, mit dem Sie sich rundum wohlfühlen.Das ist uns wichtigSie stehen bei uns im Mittelpunkt. Ihre Fähigkeiten, Erfahrungen und Wünsche sind uns sehr wichtig. Mit Ihnen gemeinsam realisieren wir Ihre Visionen und Ziele. Menschen zueinander zu bringen, ist unser höchstes Ziel. Für Sie genau das zu erreichen, motiviert uns und erfüllt unsere Arbeit täglich mit Freude.Sie erhalten von uns eine individuelle Beratung für die richtige Wahl der passenden Position, Aufgabe oder Herausforderung. Sie werden von uns während der Bewerbung bis hin zur Einstellung begleitet. Bis zum Ende Ihrer Probezeit stehen wir Ihnen dabei als Ihr "Mentor" zur Verfügung. Wenn Sie möchten, sind wir auch gerne für Ihren weiteren beruflichen Weg an Ihrer Seite.Gemeinsam mit Ihnen finden wir heraus, ob diese Position die richtigen Chancen für Sie bietet.Sie möchten wechseln? Das bleibt unter uns.Wir behandeln Ihre Unterlagen und Informationen streng vertraulich und geben diese nur mit Ihrer ausdrücklichen Einwilligung für jeden Einzelfall an Dritte weiter. Gespräche führen wir nur in Absprache mit Ihnen durch.Sie können uns jemanden empfehlen?Dann sichern Sie sich eine Empfehlungsprovision von 600 €. Hierfür muss Ihr Kandidat Sie in seiner Bewerbung namentlich erwähnen. Hat Ihr Kandidat die Probezeit erfolgreich bestanden, werden wir Ihre Provision auf Ihr Konto überweisen.Werden Sie aktiv! Wir freuen uns darauf, Sie kennenzulernen! Gemeinsam finden wir heraus, ob diese Position die richtigen Chancen für Sie bietet.Über das Unternehmen:empiricus GmbH - Agentur für IT Experten & Executives
Senior Sales Director Application Development & Maintenance (w/m/d)
Capgemini Deutschland, Berlin
Stellenbeschreibung Als Senior Sales Director (w/m/d) hast du im Bereich Application Development & Maintenance Services die Leitungsfunktion für große, komplexe Angebotserstellungen. Du bist verantwortlich für den Aufbau einer Deal Pipeline in Kooperation und enger Abstimmung mit unseren Market Units und anderen Fachbereichen, mit dem Ziel, nachhaltiges profitables Wachstum zu generieren. Mit deiner Erfahrung in Demand Generation, im Beratungsvertrieb und im Markt gestaltest und begleitest du den gesamten Sales-Prozess und erreichst so den erfolgreichen Abschluss von großen Deals bei Schlüsselkunden. Du differenzierst uns vom Wettbewerb, vermarktest unsere USPs und positionierst uns als Transformationspartner beim Kunden, um ihn bei seinen strategischen Initiativen zu begleiten und herausragende Lösungen basierend auf einem attraktiven Preis anzubieten. Dein neuer JobBegleitung der Angebote (RFP/RFI) durch alle Phasen (vom Lösungsdesign über Aufwandskalkulationen und -optimierungen, Zielpreisfindung bis hin zur finalen Auftragserteilung und Übergabe an die DeliverySicheres Führen von Kundenworkshops sowie Halten von PräsentationenOrchestrieren der Solution Teams über sämtliche Bereiche hinwegSteuerung der für die Projektlösung relevanten Fachbereiche unter Einbeziehung interner und externer Allianzen und PartnerVoranbringen von Large Deals durch einen differenzierenden und Mehrwert generierenden LösungsansatzKontaktpflege mit unseren Kunden und Freude am NetzwerkenDein ProfilMindestens 10 Jahre Berufserfahrung im Business- und Technologie-Bereich mit einem belastbaren Kunden- und Industrie-Netzwerk und davon mindestens 5 Jahre im Bereich Business Development & SalesErfahrung in den folgenden Industrien: Energie, Chemie, Fertigung, Life Sciences, Retail und KonsumgüterFähigkeit, Angebotserstellungen & Prozesse intern sowie extern mit relevanten Stakeholdern erfolgreich zu orchestrieren und zu führenErfahrung im Generieren von Large Deals, idealerweise inkl. Anlagen- und Personal-Transfers sowie Erfahrung in Vertragsverhandlungen und Kenntnis lokaler Gesetze und RegularienErfahrung in Kerntechnologien und -methoden, beispielsweise DevOps, SAP S4H, Cloud, sowie industriespezifischen Themen wie IoTReisebereitschaft innerhalb DeutschlandsEnglisch und Deutsch verhandlungssicher (mindestens C1)Bewirb dich jetztGet The Future You Want – für den ersten Schritt in Richtung Zukunft brauchst du nur drei Minuten Zeit und deinen aktuellen Lebenslauf. Du möchtest weitere Dokumente mit uns teilen? Mit wenigen Klicks kannst du sie deiner Bewerbung optional hinzufügen.Bei Fragen steht dir Laureana Teichert unter [email protected] zur Seite.Diese Anzeige ist online, solange die Stelle verfügbar ist. Wir freuen uns auf deine aussagekräftige Online-Bewerbung. Bitte habe Verständnis, dass wir keine postalischen Bewerbungen berücksichtigen und Originalunterlagen nicht zurückgeschickt werden können.Wir legen großen Wert auf die Vereinbarkeit von Arbeit und Privatleben. Deshalb hast du bei uns die Möglichkeit, hybrid aus dem Office, von zu Hause oder an anderen Capgemini Standorten in Deutschland zu arbeiten.Capgemini lebt Vielfalt am Arbeitsplatz. Diversität sorgt in unserem Unternehmen für Inspiration und Innovation. Wir freuen uns besonders über Bewerbungen von qualifizierten Talenten, unabhängig von Herkunft, Nationalität, Geschlecht, Hautfarbe, ethnischer und sozialer Herkunft, Religion, Alter, Behinderung, sexueller Orientierung und Lebensphase.Mehr InfosErfahre hier mehr zu unserem Bewerbungsprozess und erhalte Tipps für deine Bewerbung. Steig jetzt bei Capgemini ein und profitiere von unseren zahlreichen Benefits. Mehr Informationen zu den IT-Berufsfeldern bei Capgemini und unseren Standorten in Deutschland findest du auf unserer Karriereseite: capgemini.de/karriereSämtliche in der Anzeige genannten Nebenleistungen geben lediglich einen ersten Überblick ohne Anerkennung einer Rechtspflicht. Sie richten sich nach den jeweils gültigen Betriebsvereinbarungen, Policies, betrieblichen Regelungen und Anspruchsvoraussetzungen zum Zeitpunkt des Eintritts in das Unternehmen.Informiere dich auf glassdoor und kununu, wie unsere Mitarbeiter*innen Capgemini als Arbeitgeber bewerten.
Director Regulatory Strategy, CMC, Poland - P
TalentSource Life Sciences,
Location: Poland - home-based    Schedule: Full-time, permanent         CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a Director Regulatory Strategy, CMC to join our internal team.         As Director of Regulatory Strategy - CMC, you will be responsible for leading and managing regulatory strategy engagements with our clients, providing strategic guidance, and ensuring compliance with global regulatory requirements. You will serve as the primary regulatory point of contact for our clients, establishing and maintaining strong relationships while delivering exceptional service and regulatory solutions. Your expertise in CMC will enable you to competently communicate with clients concerning CMC activities, providing guidance while working with our global team to develop, review, and execute tailored regulatory strategies that support our clients' product development, registration, and post-approval activities.       Join our team and help us deliver clinical trials that will improve patients' lives.         Main Job Tasks and Responsibilities:Serve as the primary regulatory point of contact for clients, fostering strong relationships, understanding their regulatory needs, and providing expert guidance throughout the regulatory process.Collaborate with clients to develop and implement strategic regulatory plans for their products, focusing on CMC aspects, to support successful regulatory submissions and approvals.Provide expert guidance and interpretation of global regulatory requirements, guidelines, and industry best practices related to CMC, ensuring compliance in clients' regulatory strategies.Lead and manage client engagements, including project scoping, timelines, resource allocation, and deliverable management, while ensuring exceptional client service and satisfactionConduct regulatory assessments and gap analyses for clients' products, identifying potential regulatory risks, challenges, and opportunities, and providing strategic recommendations.Prepare and review CMC documentation, including drug substance and drug product specifications, manufacturing processes, stability data, and quality control strategies, to ensure compliance with regulatory standards.Lead and support the preparation and submission of CMC sections for regulatory filings, including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval submissions, ensuring high-quality and timely delivery.Stay current with global regulatory trends, changes, and evolving requirements in CMC, and proactively communicate updates to clients, guiding them on necessary adaptations.Represent the company at client meetings, regulatory agency interactions, and industry conferences, effectively communicating regulatory strategies, addressing inquiries, and building credibility and partnerships.Collaborate cross-functionally with internal teams, such as Medical Affairs, Safety, and Clinical Operations, to ensure alignment and seamless execution of clients' regulatory strategies.Participate in preparing written and presented bid developments for new clients.Prepare and present client metrics as needed.Identify opportunities for business growth to ensure on-going client support and positive engagement.Provide input on business strategic plans and managing outcome.Understand project scope of work and contract negotiation to identify when contracts need to be updated and ensure that SOW is being met throughout the project lifetime.Mentor and provide guidance to junior regulatory professionals, fostering their professional growth and ensuring high-quality work.Continuously assess and improve internal regulatory processes, tools, and systems to enhance operational efficiency and regulatory service delivery.Monitor regulatory landscape and communicate to senior leadership any impacts of guidelines and policies that can create business opportunities for the organization.Monitor Regulatory environment and communicate any changes and impact assessments to all team members. Education and Experience:Bachelors or Masters degree in a scientific field.Extensive experience (at least 15 years) in regulatory affairs, with a strong focus on CMC, within the pharmaceutical or biotechnology industry.Small molecule or biologics experience.Proven track record of successfully developing and executing regulatory strategies for complex global drug development programs.Exceptional client relationship management skills, with experience in a client-facing role, and the ability to understand and address client needs effectively.Strong understanding of drug development processes, regulatory submissions including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval activities.Leadership experience, including the ability to lead and mentor a team of regulatory professionals. Specific Role Requirements and Skills:Excellent communication, negotiation, and presentation skills, with the ability to influence and build relationships with clients, regulatory agencies, and internal stakeholders.Strong analytical and problem-solving skills, with the ability to think strategically and make sound decisions in complex regulatory environments.Proficiency in using regulatory systems, databases, and software.Established leadership and management skills with cross-functional teams in a matrixed organizational structure.Business and strategic orientation, development of people, and processes.Excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups. The Benefits of Working in Poland:Internet compensation of up to PLN 80 per monthInsurances: Group Accident (employer funded), medical care, and social fund (as per Polish regulations)PPK Pension participation (as per Polish regulations)Meal VouchersFlexible working hoursOccasional work from homeHolidays: Between 20 and 26 days per year, depending on seniorityRefund on corrective glasses for computer work (as per Polish regulations)Annual Christmas partySeniority Bonus (5y-1.000PLN, 10y-2.000PLN,15y-3.000PLN, 20y-4.000PLN)  The Application Process    Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.      If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs or please contact [email protected] for more information.         Who will you be working for?         About CROMSOURCE          CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                          Our Company Ethos    Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.         CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.         Keywords: Director Regulatory Strategy, Director Regulatory Strategy, CMC, Senior Manager Regulatory Strategy, CMC, CMC Regulatory Affairs, CMC Regulatory Affairs Director, Senior Manager CMC Regulatory Affairs, Regulatory, CRO, Contract Research OrganisationSkills: Strategy Lead, CMC, CRO, Outsourcing, Regulatory, Regulatory OperationsLocation: PolandShare: LinkedIn Facebook Twitter Email
Director Regulatory Strategy, CMC, Spain - P
TalentSource Life Sciences,
Location: Spain - home-based    Schedule: Full-time, permanent         CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a Director Regulatory Strategy, CMC to join our internal team.         As Director of Regulatory Strategy - CMC, you will be responsible for leading and managing regulatory strategy engagements with our clients, providing strategic guidance, and ensuring compliance with global regulatory requirements. You will serve as the primary regulatory point of contact for our clients, establishing and maintaining strong relationships while delivering exceptional service and regulatory solutions. Your expertise in CMC will enable you to competently communicate with clients concerning CMC activities, providing guidance while working with our global team to develop, review, and execute tailored regulatory strategies that support our clients' product development, registration, and post-approval activities.       Join our team and help us deliver clinical trials that will improve patients' lives.         Main Job Tasks and Responsibilities:Serve as the primary regulatory point of contact for clients, fostering strong relationships, understanding their regulatory needs, and providing expert guidance throughout the regulatory process.Collaborate with clients to develop and implement strategic regulatory plans for their products, focusing on CMC aspects, to support successful regulatory submissions and approvals.Provide expert guidance and interpretation of global regulatory requirements, guidelines, and industry best practices related to CMC, ensuring compliance in clients' regulatory strategies.Lead and manage client engagements, including project scoping, timelines, resource allocation, and deliverable management, while ensuring exceptional client service and satisfactionConduct regulatory assessments and gap analyses for clients' products, identifying potential regulatory risks, challenges, and opportunities, and providing strategic recommendations.Prepare and review CMC documentation, including drug substance and drug product specifications, manufacturing processes, stability data, and quality control strategies, to ensure compliance with regulatory standards.Lead and support the preparation and submission of CMC sections for regulatory filings, including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval submissions, ensuring high-quality and timely delivery.Stay current with global regulatory trends, changes, and evolving requirements in CMC, and proactively communicate updates to clients, guiding them on necessary adaptations.Represent the company at client meetings, regulatory agency interactions, and industry conferences, effectively communicating regulatory strategies, addressing inquiries, and building credibility and partnerships.Collaborate cross-functionally with internal teams, such as Medical Affairs, Safety, and Clinical Operations, to ensure alignment and seamless execution of clients' regulatory strategies.Participate in preparing written and presented bid developments for new clients.Prepare and present client metrics as needed.Identify opportunities for business growth to ensure on-going client support and positive engagement.Provide input on business strategic plans and managing outcome.Understand project scope of work and contract negotiation to identify when contracts need to be updated and ensure that SOW is being met throughout the project lifetime.Mentor and provide guidance to junior regulatory professionals, fostering their professional growth and ensuring high-quality work.Continuously assess and improve internal regulatory processes, tools, and systems to enhance operational efficiency and regulatory service delivery.Monitor regulatory landscape and communicate to senior leadership any impacts of guidelines and policies that can create business opportunities for the organization.Monitor Regulatory environment and communicate any changes and impact assessments to all team members. Education and Experience:Bachelors or Master's degree in a scientific field.Extensive experience (at least 15 years) in regulatory affairs, with a strong focus on CMC, within the pharmaceutical or biotechnology industry.Small molecule or biologics experience.Proven track record of successfully developing and executing regulatory strategies for complex global drug development programs.Exceptional client relationship management skills, with experience in a client-facing role, and the ability to understand and address client needs effectively.Strong understanding of drug development processes, regulatory submissions including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval activities.Leadership experience, including the ability to lead and mentor a team of regulatory professionals. Specific Role Requirements and Skills:Excellent communication, negotiation, and presentation skills, with the ability to influence and build relationships with clients, regulatory agencies, and internal stakeholders.Strong analytical and problem-solving skills, with the ability to think strategically and make sound decisions in complex regulatory environments.Proficiency in using regulatory systems, databases, and software.Established leadership and management skills with cross-functional teams in a matrixed organizational structure.Business and strategic orientation, development of people, and processes.Excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups. The Benefits of Working in Spain:Competitive SalaryHealth insuranceHome office allowanceMeal vouchers23 days of holiday per year + 2 convenio days and bank holidays  The Application Process    Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.      If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs or please contact mailto [email protected] for more information.     Who will you be working for?         About CROMSOURCE          CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                          Our Company Ethos    Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.         CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.         Keywords: Director Regulatory Strategy, Director Regulatory Strategy, CMC, Senior Manager Regulatory Strategy, CMC, CMC Regulatory Affairs, CMC Regulatory Affairs Director, Senior Manager CMC Regulatory Affairs, Regulatory, CRO, Contract Research OrganisationSkills: Strategy Lead, CRO, Outsourcing, Regulatory, Regulatory OperationsLocation: SpainShare: LinkedIn Facebook Twitter Email
Director Regulatory Strategy, CMC, Italy - P
TalentSource Life Sciences,
Location: Italy - home-based    Schedule: Full-time, permanent         CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a Director Regulatory Strategy, CMC to join our internal team.         As Director of Regulatory Strategy - CMC, you will be responsible for leading and managing regulatory strategy engagements with our clients, providing strategic guidance, and ensuring compliance with global regulatory requirements. You will serve as the primary regulatory point of contact for our clients, establishing and maintaining strong relationships while delivering exceptional service and regulatory solutions. Your expertise in CMC will enable you to competently communicate with clients concerning CMC activities, providing guidance while working with our global team to develop, review, and execute tailored regulatory strategies that support our clients' product development, registration, and post-approval activities.       Join our team and help us deliver clinical trials that will improve patients' lives.         Main Job Tasks and Responsibilities:Serve as the primary regulatory point of contact for clients, fostering strong relationships, understanding their regulatory needs, and providing expert guidance throughout the regulatory process.Collaborate with clients to develop and implement strategic regulatory plans for their products, focusing on CMC aspects, to support successful regulatory submissions and approvals.Provide expert guidance and interpretation of global regulatory requirements, guidelines, and industry best practices related to CMC, ensuring compliance in clients' regulatory strategies.Lead and manage client engagements, including project scoping, timelines, resource allocation, and deliverable management, while ensuring exceptional client service and satisfactionConduct regulatory assessments and gap analyses for clients' products, identifying potential regulatory risks, challenges, and opportunities, and providing strategic recommendations.Prepare and review CMC documentation, including drug substance and drug product specifications, manufacturing processes, stability data, and quality control strategies, to ensure compliance with regulatory standards.Lead and support the preparation and submission of CMC sections for regulatory filings, including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval submissions, ensuring high-quality and timely delivery.Stay current with global regulatory trends, changes, and evolving requirements in CMC, and proactively communicate updates to clients, guiding them on necessary adaptations.Represent the company at client meetings, regulatory agency interactions, and industry conferences, effectively communicating regulatory strategies, addressing inquiries, and building credibility and partnerships.Collaborate cross-functionally with internal teams, such as Medical Affairs, Safety, and Clinical Operations, to ensure alignment and seamless execution of clients' regulatory strategies.Participate in preparing written and presented bid developments for new clients.Prepare and present client metrics as needed.Identify opportunities for business growth to ensure on-going client support and positive engagement.Provide input on business strategic plans and managing outcome.Understand project scope of work and contract negotiation to identify when contracts need to be updated and ensure that SOW is being met throughout the project lifetime.Mentor and provide guidance to junior regulatory professionals, fostering their professional growth and ensuring high-quality work.Continuously assess and improve internal regulatory processes, tools, and systems to enhance operational efficiency and regulatory service delivery.Monitor regulatory landscape and communicate to senior leadership any impacts of guidelines and policies that can create business opportunities for the organization.Monitor Regulatory environment and communicate any changes and impact assessments to all team members. Education and Experience:Bachelors or Masters degree in a scientific field.Extensive experience (at least 15 years) in regulatory affairs, with a strong focus on CMC, within the pharmaceutical or biotechnology industry.Small molecule or biologics experience.Proven track record of successfully developing and executing regulatory strategies for complex global drug development programs.Exceptional client relationship management skills, with experience in a client-facing role, and the ability to understand and address client needs effectively.Strong understanding of drug development processes, regulatory submissions including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval activities.Leadership experience, including the ability to lead and mentor a team of regulatory professionals. Specific Role Requirements and Skills:Excellent communication, negotiation, and presentation skills, with the ability to influence and build relationships with clients, regulatory agencies, and internal stakeholders.Strong analytical and problem-solving skills, with the ability to think strategically and make sound decisions in complex regulatory environments.Proficiency in using regulatory systems, databases, and software.Established leadership and management skills with cross-functional teams in a matrixed organizational structure.Business and strategic orientation, development of people, and processes.Excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups. The Benefits of Working in Italy:Meal vouchersMobile phone if requested by the Line ManagerDedicated Line ManagerMonthly meetings with the line managerFull performance and development process with end-of-year reviews  The Application Process    Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.      If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs or please contact [email protected] for more information.         Who will you be working for?         About CROMSOURCE          CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                          Our Company Ethos    Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.         CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.         Keywords: Director Regulatory Strategy, Director Regulatory Strategy, CMC, Senior Manager Regulatory Strategy, CMC, CMC Regulatory Affairs, CMC Regulatory Affairs Director, Senior Manager CMC Regulatory Affairs, Regulatory, CRO, Contract Research OrganisationSkills: Strategy Lead, CMC, CRO, Outsourcing, RegulatoryLocation: ItalyShare: LinkedIn Facebook Twitter Email
Director Regulatory Strategy, CMC, Netherlands - P
TalentSource Life Sciences,
Location: Netherlands - home-based    Schedule: Full-time, permanent     CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a Director Regulatory Strategy, CMC to join our internal team.       As Director of Regulatory Strategy - CMC, you will be responsible for leading and managing regulatory strategy engagements with our clients, providing strategic guidance, and ensuring compliance with global regulatory requirements. You will serve as the primary regulatory point of contact for our clients, establishing and maintaining strong relationships while delivering exceptional service and regulatory solutions. Your expertise in CMC will enable you to competently communicate with clients concerning CMC activities, providing guidance while working with our global team to develop, review, and execute tailored regulatory strategies that support our clients' product development, registration, and post-approval activities.     Join our team and help us deliver clinical trials that will improve patients' lives.       Main Job Tasks and Responsibilities:Serve as the primary regulatory point of contact for clients, fostering strong relationships, understanding their regulatory needs, and providing expert guidance throughout the regulatory process.Collaborate with clients to develop and implement strategic regulatory plans for their products, focusing on CMC aspects, to support successful regulatory submissions and approvals.Provide expert guidance and interpretation of global regulatory requirements, guidelines, and industry best practices related to CMC, ensuring compliance in clients' regulatory strategies.Lead and manage client engagements, including project scoping, timelines, resource allocation, and deliverable management, while ensuring exceptional client service and satisfactionConduct regulatory assessments and gap analyses for clients' products, identifying potential regulatory risks, challenges, and opportunities, and providing strategic recommendations.Prepare and review CMC documentation, including drug substance and drug product specifications, manufacturing processes, stability data, and quality control strategies, to ensure compliance with regulatory standards.Lead and support the preparation and submission of CMC sections for regulatory filings, including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval submissions, ensuring high-quality and timely delivery.Stay current with global regulatory trends, changes, and evolving requirements in CMC, and proactively communicate updates to clients, guiding them on necessary adaptations.Represent the company at client meetings, regulatory agency interactions, and industry conferences, effectively communicating regulatory strategies, addressing inquiries, and building credibility and partnerships.Collaborate cross-functionally with internal teams, such as Medical Affairs, Safety, and Clinical Operations, to ensure alignment and seamless execution of clients' regulatory strategies.Participate in preparing written and presented bid developments for new clients.Prepare and present client metrics as needed.Identify opportunities for business growth to ensure on-going client support and positive engagement.Provide input on business strategic plans and managing outcome.Understand project scope of work and contract negotiation to identify when contracts need to be updated and ensure that SOW is being met throughout the project lifetime.Mentor and provide guidance to junior regulatory professionals, fostering their professional growth and ensuring high-quality work.Continuously assess and improve internal regulatory processes, tools, and systems to enhance operational efficiency and regulatory service delivery.Monitor regulatory landscape and communicate to senior leadership any impacts of guidelines and policies that can create business opportunities for the organization.Monitor Regulatory environment and communicate any changes and impact assessments to all team members. Education and Experience:Bachelors or Masters degree in a scientific field.Extensive experience (at least 15 years) in regulatory affairs, with a strong focus on CMC, within the pharmaceutical or biotechnology industry.Small molecule or biologics experience.Proven track record of successfully developing and executing regulatory strategies for complex global drug development programs.Exceptional client relationship management skills, with experience in a client-facing role, and the ability to understand and address client needs effectively.Strong understanding of drug development processes, regulatory submissions including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval activities.Leadership experience, including the ability to lead and mentor a team of regulatory professionals. Specific Role Requirements and Skills:Excellent communication, negotiation, and presentation skills, with the ability to influence and build relationships with clients, regulatory agencies, and internal stakeholders.Strong analytical and problem-solving skills, with the ability to think strategically and make sound decisions in complex regulatory environments.Proficiency in using regulatory systems, databases, and software.Established leadership and management skills with cross-functional teams in a matrixed organizational structure.Business and strategic orientation, development of people, and processes.Excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups. The Benefits of Working in the Netherlands:Competitive SalaryGroup health insuranceGreat pension scheme24 vacation days (but up to 30 days, depending on negotiation)Internet reimbursementCompany Car with fuel card depending on the function.Full performance and development process with end-of-year reviews The Application Process    Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.    If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs or please contact [email protected] for more information.         Who will you be working for?         About CROMSOURCE         CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                        Our Company Ethos    Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.         CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.         Keywords: Director Regulatory Strategy, Director Regulatory Strategy, CMC, Senior Manager Regulatory Strategy, CMC, CMC Regulatory Affairs, CMC Regulatory Affairs Director, Senior Manager CMC Regulatory Affairs, Regulatory, CRO, Contract Research OrganisationSkills: Regulatory Affairs Director, Strategy Lead, Clinical Research Organisation, CRO, Regulatory, Regulatory OperationsLocation: NetherlandsShare: LinkedIn Facebook Twitter Email
Director Regulatory Strategy, CMC, Germany - L
TalentSource Life Sciences, Germany
Location: Germany - home-based    Schedule: Full-time, permanent         CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a Director Regulatory Strategy, CMC to join our internal team.         As Director of Regulatory Strategy - CMC, you will be responsible for leading and managing regulatory strategy engagements with our clients, providing strategic guidance, and ensuring compliance with global regulatory requirements. You will serve as the primary regulatory point of contact for our clients, establishing and maintaining strong relationships while delivering exceptional service and regulatory solutions. Your expertise in CMC will enable you to competently communicate with clients concerning CMC activities, providing guidance while working with our global team to develop, review, and execute tailored regulatory strategies that support our clients' product development, registration, and post-approval activities.       Join our team and help us deliver clinical trials that will improve patients' lives.         Main Job Tasks and Responsibilities:Serve as the primary regulatory point of contact for clients, fostering strong relationships, understanding their regulatory needs, and providing expert guidance throughout the regulatory process.Collaborate with clients to develop and implement strategic regulatory plans for their products, focusing on CMC aspects, to support successful regulatory submissions and approvals.Provide expert guidance and interpretation of global regulatory requirements, guidelines, and industry best practices related to CMC, ensuring compliance in clients' regulatory strategies.Lead and manage client engagements, including project scoping, timelines, resource allocation, and deliverable management, while ensuring exceptional client service and satisfactionConduct regulatory assessments and gap analyses for clients' products, identifying potential regulatory risks, challenges, and opportunities, and providing strategic recommendations.Prepare and review CMC documentation, including drug substance and drug product specifications, manufacturing processes, stability data, and quality control strategies, to ensure compliance with regulatory standards.Lead and support the preparation and submission of CMC sections for regulatory filings, including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval submissions, ensuring high-quality and timely delivery.Stay current with global regulatory trends, changes, and evolving requirements in CMC, and proactively communicate updates to clients, guiding them on necessary adaptations.Represent the company at client meetings, regulatory agency interactions, and industry conferences, effectively communicating regulatory strategies, addressing inquiries, and building credibility and partnerships.Collaborate cross-functionally with internal teams, such as Medical Affairs, Safety, and Clinical Operations, to ensure alignment and seamless execution of clients' regulatory strategies.Participate in preparing written and presented bid developments for new clients.Prepare and present client metrics as needed.Identify opportunities for business growth to ensure on-going client support and positive engagement.Provide input on business strategic plans and managing outcome.Understand project scope of work and contract negotiation to identify when contracts need to be updated and ensure that SOW is being met throughout the project lifetime.Mentor and provide guidance to junior regulatory professionals, fostering their professional growth and ensuring high-quality work.Continuously assess and improve internal regulatory processes, tools, and systems to enhance operational efficiency and regulatory service delivery.Monitor regulatory landscape and communicate to senior leadership any impacts of guidelines and policies that can create business opportunities for the organization.Monitor Regulatory environment and communicate any changes and impact assessments to all team members. Education and Experience:Bachelors or Masters degree in a scientific field.Extensive experience (at least 15 years) in regulatory affairs, with a strong focus on CMC, within the pharmaceutical or biotechnology industry.Small molecule or biologics experience.Proven track record of successfully developing and executing regulatory strategies for complex global drug development programs.Exceptional client relationship management skills, with experience in a client-facing role, and the ability to understand and address client needs effectively.Strong understanding of drug development processes, regulatory submissions including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval activities.Leadership experience, including the ability to lead and mentor a team of regulatory professionals. Specific Role Requirements and Skills:Excellent communication, negotiation, and presentation skills, with the ability to influence and build relationships with clients, regulatory agencies, and internal stakeholders.Strong analytical and problem-solving skills, with the ability to think strategically and make sound decisions in complex regulatory environments.Proficiency in using regulatory systems, databases, and software.Established leadership and management skills with cross-functional teams in a matrixed organizational structure.Business and strategic orientation, development of people, and processes.Excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups. The Benefits of Working in Germany:30 Euro net Internet cost reimbursement per monthAdditional Accident Insurance, fully covered by the company25 vacation daysPossibility of salary conversion for additional pension insuranceDedicated Line Manager The Application Process    Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.      If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs or please contact [email protected] for more information.         Who will you be working for?         About CROMSOURCE          CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                          Our Company Ethos    Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.         CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.         Keywords: Director Regulatory Strategy, Director Regulatory Strategy, CMC, Senior Manager Regulatory Strategy, CMC, CMC Regulatory Affairs, CMC Regulatory Affairs Director, Senior Manager CMC Regulatory Affairs, Regulatory, CRO, Contract Research OrganisationSkills: Regulatory Affairs Director, Strategy Lead, Clinical Research Organisation, CRO, Regulatory, Regulatory OperationsLocation: GermanyShare: LinkedIn Facebook Twitter Email
Director Regulatory Strategy, CMC, Belgium - P
TalentSource Life Sciences,
Location: Belgium - home-based    Schedule: Full-time, permanent     CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a Director Regulatory Strategy, CMC to join our internal team.       As Director of Regulatory Strategy - CMC, you will be responsible for leading and managing regulatory strategy engagements with our clients, providing strategic guidance, and ensuring compliance with global regulatory requirements. You will serve as the primary regulatory point of contact for our clients, establishing and maintaining strong relationships while delivering exceptional service and regulatory solutions. Your expertise in CMC will enable you to competently communicate with clients concerning CMC activities, providing guidance while working with our global team to develop, review, and execute tailored regulatory strategies that support our clients' product development, registration, and post-approval activities.     Join our team and help us deliver clinical trials that will improve patients' lives.       Main Job Tasks and Responsibilities:Serve as the primary regulatory point of contact for clients, fostering strong relationships, understanding their regulatory needs, and providing expert guidance throughout the regulatory process.Collaborate with clients to develop and implement strategic regulatory plans for their products, focusing on CMC aspects, to support successful regulatory submissions and approvals.Provide expert guidance and interpretation of global regulatory requirements, guidelines, and industry best practices related to CMC, ensuring compliance in clients' regulatory strategies.Lead and manage client engagements, including project scoping, timelines, resource allocation, and deliverable management, while ensuring exceptional client service and satisfactionConduct regulatory assessments and gap analyses for clients' products, identifying potential regulatory risks, challenges, and opportunities, and providing strategic recommendations.Prepare and review CMC documentation, including drug substance and drug product specifications, manufacturing processes, stability data, and quality control strategies, to ensure compliance with regulatory standards.Lead and support the preparation and submission of CMC sections for regulatory filings, including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval submissions, ensuring high-quality and timely delivery.Stay current with global regulatory trends, changes, and evolving requirements in CMC, and proactively communicate updates to clients, guiding them on necessary adaptations.Represent the company at client meetings, regulatory agency interactions, and industry conferences, effectively communicating regulatory strategies, addressing inquiries, and building credibility and partnerships.Collaborate cross-functionally with internal teams, such as Medical Affairs, Safety, and Clinical Operations, to ensure alignment and seamless execution of clients' regulatory strategies.Participate in preparing written and presented bid developments for new clients.Prepare and present client metrics as needed.Identify opportunities for business growth to ensure on-going client support and positive engagement.Provide input on business strategic plans and managing outcome.Understand project scope of work and contract negotiation to identify when contracts need to be updated and ensure that SOW is being met throughout the project lifetime.Mentor and provide guidance to junior regulatory professionals, fostering their professional growth and ensuring high-quality work.Continuously assess and improve internal regulatory processes, tools, and systems to enhance operational efficiency and regulatory service delivery.Monitor regulatory landscape and communicate to senior leadership any impacts of guidelines and policies that can create business opportunities for the organization.Monitor Regulatory environment and communicate any changes and impact assessments to all team members. Education and Experience:Bachelors or Masters degree in a scientific field.Extensive experience (at least 15 years) in regulatory affairs, with a strong focus on CMC, within the pharmaceutical or biotechnology industry.Small molecule or biologics experience.Proven track record of successfully developing and executing regulatory strategies for complex global drug development programs.Exceptional client relationship management skills, with experience in a client-facing role, and the ability to understand and address client needs effectively.Strong understanding of drug development processes, regulatory submissions including INDs, CTAs, NDAs, BLAs, MAAs, and post-approval activities.Leadership experience, including the ability to lead and mentor a team of regulatory professionals. Specific Role Requirements and Skills:Excellent communication, negotiation, and presentation skills, with the ability to influence and build relationships with clients, regulatory agencies, and internal stakeholders.Strong analytical and problem-solving skills, with the ability to think strategically and make sound decisions in complex regulatory environments.Proficiency in using regulatory systems, databases, and software.Established leadership and management skills with cross-functional teams in a matrixed organizational structure.Business and strategic orientation, development of people, and processes.Excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups. The Benefits of Working in Belgium:Competitive SalaryGroup and hospitalisation insuranceElectronic meal vouchersInternet reimbursementCompany Car with fuel card depending on the function.Dedicated Line Manager The Application Process    Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.    If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs or please contact [email protected] for more information.         Who will you be working for?         About CROMSOURCE         CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                        Our Company Ethos    Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.         CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.         Keywords: Director Regulatory Strategy, Director Regulatory Strategy, CMC, Senior Manager Regulatory Strategy, CMC, CMC Regulatory Affairs, CMC Regulatory Affairs Director, Senior Manager CMC Regulatory Affairs, Regulatory, CRO, Contract Research OrganisationSkills: Regulatory Affairs Director, Strategy Lead, Clinical Research Organisation, CRO, Regulatory, Regulatory OperationsLocation: BelgiumShare: LinkedIn Facebook Twitter Email
Director – Procurement Digitalization and Processes (m/f/d)
0102 Harman Holding GmbH & Co. KG, DE_Karlsbad_Becker Göring Straße
A Career at HARMAN As a technology leader that is rapidly on the move, HARMAN is filled with people who are focused on making life better. Innovation, inclusivity and teamwork are a part of our DNA. When you add that to the challenges we take on and solve together, you’ll discover that at HARMAN you can grow, make a difference and be proud of the work you do every day. About the Role We are in search of an experienced and visionary leader to assume the pivotal role of Director - Procurement Digitalization and Processes. As the Director, you will hold end-to-end responsibility for steering the procurement digitalization roadmap and elevating our procurement organization to a best-in-class digital working environment. Leading a team of global project leads and procurement specialists, you will champion successful coordination and execution of digitalization projects, ensuring procurement's strategic impact within the organization. Reporting directly to the Procurement Excellence lead, your role will be instrumental in achieving digitalization milestones, influencing business processes and frameworks, and positioning procurement as a digital leader. Your Team Your team consists of 6-8 direct reports looking to you for both functional and disciplinary guidance in this global leadership role. What You Will Do Digital Procurement Framework & Procurement Digitalization Roadmap: This position will be the owner of all procurement related digital solutions & frameworks within the company, including budget responsibility of 3-7 Mio. USD/year, leading also related problem solving, improving and escalation activities End-to-end responsibility for the procurement digitalization roadmap and related budget. It involves not only ownership of the digitalization strategy but also the execution and enhancement of all procurement processes and systems Define and execute initiatives to develop & enhance procurement processes, systems, and digital capabilities targeting to achieve compliance requirements and leading to year over year efficiencies on bound capacities within the organization Stay abreast of digitalization trends and emerging technologies in the procurement field. Team Leadership & Strategic Decision Making Lead a team of global procurement managers following yearly 10-15 digitalization improvement projects and procurement specialists being subject matter experts on specific digital procurement solutions as well as owners of the procurement process landscape. Provide functional and disciplinary guidance, coaching, and support to the team members, providing escalation support to direct reports for critical decision-making processes. Foster a collaborative and high-performing team culture focused on achieving digitalization goals. Coordination and Execution of Digitalization Projects: Ensure successful coordination and execution of multiple ongoing digitalization projects led by the team. Be responsible for successful execution of project timelines, budgets, and quality to achieve targeted outcomes. Provide escalation support to direct reports to facilitate critical decision-making processes. Cross-Functional Representation and Alignment: Represent procurement in senior management meetings, focusing on digitalization initiatives. Represent procurement in cross functional digitalization initiatives outside the procurement organization. Drive cross-functional alignment on all levels of management within and outside the procurement organization. Advocate for procurement digitalization needs and actively contribute to broader organizational digital initiatives. Stakeholder Engagement and Communication: Achieve stakeholder acceptance within and outside the procurement organization by effectively communicating the value of digitalization initiatives. Provide periodic status reports on project progress, risks, and mitigation strategies. Engage executive management participants as needed to ensure project success within defined timeframes and frameworks. What You Need University degree in a business or digital function or equivalent experience 10+ years of relevant business experience within procurement digitalization, consulting or surrounding functions Extensive experience in procurement digitalization, process improvement, or related areas, preferably in a leadership role. Strong knowledge of digitalization trends, emerging technologies, and their application in procurement. Proven leadership skills with the ability to lead and inspire a diverse team. Excellent strategic thinking, decision-making, and problem-solving abilities. Effective communication and presentation skills, with the ability to engage stakeholders at all levels. Strong organizational and project management skills. Familiarity with change management principles and methodologies. Ability to work in a fast-paced, dynamic environment. Experience in leading global intercultural teams Strong stakeholder management skills and ability to mediate between conflicted parties What is Nice to Have MBA or Masters degree Experience in different procurement functions within and outside HARMAN Experience with introducing digitalization roadmaps and projects Experience in change management projects and/or managing cross functional projects and teams What Makes You Eligible Be willing to travel up to 25% domestic and international What We Offer Flexible work environment Access to employee discounts on world-class Harman and Samsung products (JBL, HARMAN Kardon, AKG, etc.) Extensive training opportunities through our own HARMAN University Competitive wellness benefits Tuition Reimbursement An inclusive and diverse work environment that fosters and encourages professional and personal development HARMAN is an Equal Opportunity /Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race,color, religion, sex, sexual orientation, gender identity, national origin,disability or Protected Veterans status. HARMAN offers a great work environment, challenging career opportunities, professional training and competitive compensation. (www.harman.com) About HARMAN International HARMAN (harman.com) designs and engineers connected products and solutions for consumers, automakers, and enterprises worldwide, including audio, visual and infotainment systems; enterprise automation solutions; and software services. With leading brands including AKG, Harman Kardon, Infinity, JBL, Lexicon , Mark Levinson and Revel, HARMAN is admired by audiophiles, musicians and the entertainment venues where they perform around the world. HARMAN also is a technology and integration services leader for the Automotive, Mobile, Telecommunications and Enterprise markets. More than 25 million automobiles on the road today are equipped with HARMAN audio and infotainment systems. The Company's software solutions power billions of mobile devices and systems that are connected, integrated, personalized, adaptive and secure across all platforms, from the work and home to car and mobile. HARMAN has a workforce of approximately 30,000 people across the Americas, Europe, and Asia. In March 2017, HARMAN became a wholly-owned subsidiary of Samsung Electronics. HARMAN is an Equal Opportunity, Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or Protected Veterans status. HARMAN offers a great work environment, brilliant career opportunities, professional training and competitive compensation. Looking for a challenge where your experience is valued? Come see what you can achieve as a leader with HARMAN! DO NOT apply on this page. Click HARMAN logo in top left to search and apply.Über das Unternehmen:0102 Harman Holding GmbH & Co. KG
Director Revenue Management and Key Accounts Europe
Wyndham Hotels & Resorts, Berlin, BE
Wyndham Hotels & Resorts is now seeking a Director Revenue Management and Key Accounts Europe to join our team in Germany.Job SummaryThe position serves as Europe region’s leader in revenue management, creating strategies to maximize the region’s room revenue and grow the RevPAR Index (market share) for each hotel in the portfolio. This involves leadership of two distinct areas of work: Managing regional RMS Teams and developing/monitoring revenue management and distribution strategies to key accounts in the region. The Position covers the following activities: Oversight of rate plans available to all hotels in the region in collaboration with EMEA Revenue Management on strategic design and implementation of new rate plans to address market requirements of hotels.Develop close relationships with key partners providing revenue management support including rate plan consultations, systems setup, and strategies to optimize revenue performance.Training for Operations and Hotel teams on Rate Plans available to hotels including best practices and revenue management strategies.Selection and oversite of 3rd party Revenue Management Service Providers delivering tools & reporting systems to hotelsClose collaboration with sub-regional Operation and Commercial leaders to align on strategies to drive Wyndham’s Contribution.Representation at industry forums and events related to revenue management best practices and industry trends.ComplexityDecision-making authority is at a medium level, given this role is accountable for design of rate plans and systems impacting revenue generation for hotels.Acts as supervisor and mentor to RM Analyst(s) and Specialist(s) and Manager(s) Work consists of strategic planning, analysis and training plus oversite of routine tasks, processes, and operations. The employee defines and delivers clearly prescribed, standard policies and procedures. Requires strategic thinking and analysis to put forward options for review with internal and external stakeholders and line management.Problems are sometimes complex and involve a mix of solutions ranging from a set of pre-designed options to bespoke developments.Work requires active involvement in projects that result in new ideas or methods. Improved methods generally affect the hotel’s bottom line performance and immediate department. Serves as a project team member working to achieve defined goals. Require regular contact with property designated contacts; interaction within the department and periodic contacts with other departments, supplying or seeking information on specialized matters.Scope/Financial ResponsibilityThe position has a revenue impact as it relates to ensuring that Brand Standards, Revenue Management Policies, and Best Practices. All these are designed to generate incremental revenues, and customer loyalty, and increase brand awareness for properties while minimizing opportunity costs of not having adequate rates and inventory available for sale across various channels.This position and its direct reports can have an impact on a hotel’s top-line revenues.Abilities/Key Competencies/SkillsMust have detailed expert-level knowledge of revenue management strategies and systemsMust be able to show initiative in job performance, including anticipating, preventing, identifying and solving problems as necessary.Ability to analyse, interpret and explain statistical data, to develop strategies and generate a course of action. Must have the ability to assimilate information, data, etc. from disparate sources and consider, adjust or modify to meet the constraints of the particular need.Must have excellent interpersonal skills that build trust and in still confidence in order to motivate and influence othersMust be effective at listening, understanding, and clarifying the concerns and issues raised by key clients, co-workers and supervisors.High proficiency withMS-Office, Salesforce, BI Tools, and RMS systems that may be designated by the company.Experience/Certificates/EducationBA/BS bachelor’s degree in hospitality, Business Administration, Finance, or Economics or a minimum of six (6) years of experience in Revenue Management A minimum of three (3) years of director-level experience in international marketsCentral Europe / Germany market knowledge at director level experience is a must.Experience managing key account relationships.Global Acumen demonstrating the ability to effectively work across different cultures and teams.Hospitality industry experience is a must. Proficient in Revenue Management systems, hotel property management systems, and industry-related reportsFluency in English and German is essential. COMPANY OVERVIEW: Wyndham Hotels & Resorts is the world’s largest hotel franchising company by the number of properties with approximately 9,100 hotels across over 95 countries on six continents. Through our network of more than 836,000 rooms appealing to the everyday traveler, Wyndham commands a leading presence in the hospitality industry. Headquartered in Parsippany, N.J. with offices around the world in London, Shanghai, Buenos Aires, Dubai and more, Wyndham employs more than 2,000 corporate team members worldwide who are dedicated to the Company’s mission of making hotel travel possible for all. Supporting thousands of franchisees and a growing global portfolio of 24 hotel brands—think household names like Wyndham, La Quinta, Ramada, Days Inn and Super 8—Wyndham team members are a widespread group of individuals with diverse interests and backgrounds. Our unique Count on Me culture, commitment to flexibility and core values of Integrity, Accountability, Inclusivity, Caring and Fun are just part of what continues to make Wyndham an award-winning best place to work. Wyndham Hotels & Resorts is an Equal Employment Opportunity Employer.Employment Status: Full-timeÜber das Unternehmen:Wyndham Hotels & Resorts
Medical Director / Gynaecologist
Merantix, Berlin
What we doOVOM aims at redefining how reproductive care is brought to patients by combining modern in-person care with advanced AI-based technology. Catering not just to patients but also to healthcare professionals, we create an ecosystem that allows for increased success rates, improved accessibility, and reduced life disruption for patients.It is our mission to enable every human that seeks to build a family, to become a parent.Your roleWe are seeking a highly skilled and motivated gynaecologist to join our team and establish a new gynaecology practice in Berlin, with a specific focus on reproductive care. The gynaecologists will own the practice, while OVOM will provide the necessary infrastructure to make the practice successful.Your responsibilities will include: Establish and operate a gynaecology practice with a focus on reproductive care in Berlin.Provide high-quality medical care to patients with a compassionate and professional approach.Develop and implement practice policies and procedures together with the OVOM management team to ensure the efficient and patient centric operations.Maintain complete and accurate medical records for all patients.Participate in continuing education programs to stay up-to-date with the latest medical advances and techniques.Your profileMedical degree and board certification in gynaecology.Proven experience in treating patients with reproductive care needs.Excellent diagnostic and problem-solving skills.Strong communication and interpersonal skills with the ability to build and maintain relationships with patients and colleagues.Ability to work independently and as part of a team.Fluency in German and English.What we offerOpportunity to establish and own your own practice in partnership with OVOM.Access to state-of-the-art medical equipment and facilities.Support from a dedicated team of medical and administrative staff.Potential for long-term growth and career advancement.Create the future of reproductive care with a highly experienced and dedicated team.If you are passionate about providing exceptional medical care and want to be part of an exciting new venture in reproductive care in Berlin, we want to hear from you! Please send us your CV!About usWe are an equal-opportunity employer and value diversity. We consider all applications equally regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. We strongly encourage individuals from groups traditionally underrepresented in tech to apply, and we can help with immigration.Über das Unternehmen:Merantix
Sr. Director Pharmacovigilance Operations, Belgium - P
TalentSource Life Sciences,
Location: Belgium - Hybrid (2 days in office)Schedule: Full-time, permanent     CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Senior Director, Pharmacovigilance Operations.     The Senior Director of Pharmacovigilance Operations will be responsible for delivering pharmacovigilance services to global clients. The Pharmacovigilance team is responsible for supporting a diverse range of clients (pharmaceutical, biotechnology, OTCs, medical devices, and consumer), working closely with Global Delivery Centers in North America, Europe, and Asia to provide services to global clients.     Join our team and help us deliver clinical trials that will improve patients' lives.       Main Job Tasks and Responsibilities:Ensures the Pharmacovigilance team manages client projects as per the contractual agreements and delivers high-quality services.Collaborates with the Global Head of PV and provides oversight and guidance to global team and delivery centers for projects which include but are not limited to Signal detection and evaluation, Literature Management, Safety Surveillance, Aggregate Reports, Risk Management Plans, ICSRs (PV Case Processing), Audit Support, Safety Management for Clinical Trials, Medical Writing, Other PV SupportBalancing resource requirements across the clients and promoting a pragmatic, flexible, and focused approach to workload.Collaborates and at times initiates process improvement projects by working with global teams.Provides progress of work plans and the status of key project deliverables.Identifies innovative solutions to meet clients' requirements and business objectives in partnership with global delivery teams and SMEs.Monitors, assesses the potential impact develops appropriate strategies for new or emerging regulations, and proposes new service offerings to the management team.Preparing bid-defense response for safety and clinical RFPs.Support sales activities such as bid-defense meetings, new client interactions, capabilities presentations, etc. for safety and clinical projects.Maintains strong relationships with existing clients and has a thorough understanding of our services.Leads/participates in client interactions and governance meetings.Advises on any new technology development and collaborates with internal team/external consultants to support the design and implementation of new technology. Education and Experience:Physician or PharmD or PhD in life sciences.The successful candidate will have 15-20 years of experience in drug safety (ICSR, periodic reporting, safety surveillance is a must) and a working knowledge of key pharmacovigilance regulations and methodologies.Experience in people management.Experience with CRO/BPO is preferred.Broad knowledge of clinical development and/or safety requirements from pre-clinical to post-marketing.Strong leadership skills with a demonstrated track record of successfully managing and leading a diverse and globally distributed team.The Application Process  Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected]@cromsource.com for more information.     Who will you be working for?     About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                    Our Company Ethos  Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates.     About TalentSource Life Sciences  TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously.     CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.     Keywords: Senior Director, Pharmacovigilance Operations, Senior Director of Pharmacovigilance, Pharmacovigilance Operations, Senior Director, Medical Monitor, Monitor, Clinical Physician, Physician, ICH-GCP, Submissions, Clinical Research, CRO, Clinical Research Organisation, Clinical Trials, Clinical, ICH-GCP, Submissions.Skills: Medical Monitor, Pharmacovigilance Manager, Pharmacovigilance Officer, clinical trials, ICH-GCP, PharmacovigilanceLocation: BelgiumShare: LinkedIn Facebook Twitter Email
Sr. Director Pharmacovigilance Operations, Italy - P
TalentSource Life Sciences,
Location: Italy - Hybrid (2 days in office)Schedule: Full-time, permanent CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Senior Director, Pharmacovigilance Operations. The Senior Director of Pharmacovigilance Operations will be responsible for delivering pharmacovigilance services to global clients. The Pharmacovigilance team is responsible for supporting a diverse range of clients (pharmaceutical, biotechnology, OTCs, medical devices, and consumer), working closely with Global Delivery Centers in North America, Europe, and Asia to provide services to global clients. Join our team and help us deliver clinical trials that will improve patients' lives.   Main Job Tasks and Responsibilities: Ensures the Pharmacovigilance team manages client projects as per the contractual agreements and delivers high-quality services.Collaborates with the Global Head of PV and provides oversight and guidance to global team and delivery centers for projects which include but are not limited to Signal detection and evaluation, Literature Management, Safety Surveillance, Aggregate Reports, Risk Management Plans, ICSRs (PV Case Processing), Audit Support, Safety Management for Clinical Trials, Medical Writing, Other PV SupportBalancing resource requirements across the clients and promoting a pragmatic, flexible, and focused approach to workload.Collaborates and at times initiates process improvement projects by working with global teams.Provides progress of work plans and the status of key project deliverables.Identifies innovative solutions to meet clients' requirements and business objectives in partnership with global delivery teams and SMEs.Monitors, assesses the potential impact develops appropriate strategies for new or emerging regulations, and proposes new service offerings to the management team.Preparing bid-defense response for safety and clinical RFPs.Support sales activities such as bid-defense meetings, new client interactions, capabilities presentations, etc. for safety and clinical projects.Maintains strong relationships with existing clients and has a thorough understanding of our services.Leads/participates in client interactions and governance meetings.Advises on any new technology development and collaborates with internal team/external consultants to support the design and implementation of new technology. Education and Experience:Physician or PharmD or PhD in life sciences.The successful candidate will have 15-20 years of experience in drug safety (ICSR, periodic reporting, safety surveillance is a must) and a working knowledge of key pharmacovigilance regulations and methodologies.Experience in people management.Experience with CRO/BPO is preferred.Broad knowledge of clinical development and/or safety requirements from pre-clinical to post-marketing.Strong leadership skills with a demonstrated track record of successfully managing and leading a diverse and globally distributed team.The Application Process Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected]@cromsource.com for more information. Who will you be working for?  About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                  Our Company Ethos Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates. About TalentSource Life Sciences  TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously.  CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status. Keywords: Senior Director, Pharmacovigilance Operations, Senior Director of Pharmacovigilance, Pharmacovigilance Operations, Senior Director, Medical Monitor, Monitor, Clinical Physician, Physician, ICH-GCP, Submissions, Clinical Research, CRO, Clinical Research Organisation, Clinical Trials, Clinical, ICH-GCP, SubmissionsSkills: Medical Monitor, Pharmacovigilance Manager, Pharmacovigilance Officer, clinical trials, ICH-GCP, PharmacovigilanceLocation: ItalyShare: LinkedIn Facebook Twitter Email
Sr. Director Pharmacovigilance Operations, Spain - P
TalentSource Life Sciences,
Location: Spain - Hybrid (2 days in office)Schedule: Full-time, permanent CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Senior Director, Pharmacovigilance Operations. The Senior Director of Pharmacovigilance Operations will be responsible for delivering pharmacovigilance services to global clients. The Pharmacovigilance team is responsible for supporting a diverse range of clients (pharmaceutical, biotechnology, OTCs, medical devices, and consumer), working closely with Global Delivery Centers in North America, Europe, and Asia to provide services to global clients. Join our team and help us deliver clinical trials that will improve patients' lives.   Main Job Tasks and Responsibilities: Ensures the Pharmacovigilance team manages client projects as per the contractual agreements and delivers high-quality services.Collaborates with the Global Head of PV and provides oversight and guidance to global team and delivery centers for projects which include but are not limited to Signal detection and evaluation, Literature Management, Safety Surveillance, Aggregate Reports, Risk Management Plans, ICSRs (PV Case Processing), Audit Support, Safety Management for Clinical Trials, Medical Writing, Other PV SupportBalancing resource requirements across the clients and promoting a pragmatic, flexible, and focused approach to workload.Collaborates and at times initiates process improvement projects by working with global teams.Provides progress of work plans and the status of key project deliverables.Identifies innovative solutions to meet clients' requirements and business objectives in partnership with global delivery teams and SMEs.Monitors, assesses the potential impact develops appropriate strategies for new or emerging regulations, and proposes new service offerings to the management team.Preparing bid-defense response for safety and clinical RFPs.Support sales activities such as bid-defense meetings, new client interactions, capabilities presentations, etc. for safety and clinical projects.Maintains strong relationships with existing clients and has a thorough understanding of our services.Leads/participates in client interactions and governance meetings.Advises on any new technology development and collaborates with internal team/external consultants to support the design and implementation of new technology. Education and Experience:Physician or PharmD or PhD in life sciences.The successful candidate will have 15-20 years of experience in drug safety (ICSR, periodic reporting, safety surveillance is a must) and a working knowledge of key pharmacovigilance regulations and methodologies.Experience in people management.Experience with CRO/BPO is preferred.Broad knowledge of clinical development and/or safety requirements from pre-clinical to post-marketing.Strong leadership skills with a demonstrated track record of successfully managing and leading a diverse and globally distributed team.The Application Process Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected]@cromsource.com for more information. Who will you be working for?  About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                   Our Company Ethos Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates. About TalentSource Life Sciences  TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously.  CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.  Keywords: Senior Director, Pharmacovigilance Operations, Senior Director of Pharmacovigilance, Pharmacovigilance Operations, Senior Director, Medical Monitor, Monitor, Clinical Physician, Physician, ICH-GCP, Submissions, Clinical Research, CRO, Clinical Research Organisation, Clinical Trials, Clinical, ICH-GCP, Submissions.Skills: Medical Monitor, Pharmacovigilance Manager, Pharmacovigilance Officer, clinical trials, ICH-GCP, PharmacovigilanceLocation: SpainShare: LinkedIn Facebook Twitter Email
Senior Director of Pharmacovigilance Operations, Poland - P
TalentSource Life Sciences,
Location: Poland - Hybrid (2 days in office)Schedule: Full-time, permanent CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Senior Director, Pharmacovigilance Operations. The Senior Director of Pharmacovigilance Operations will be responsible for delivering pharmacovigilance services to global clients. The Pharmacovigilance team is responsible for supporting a diverse range of clients (pharmaceutical, biotechnology, OTCs, medical devices, and consumer), working closely with Global Delivery Centers in North America, Europe, and Asia to provide services to global clients. Join our team and help us deliver clinical trials that will improve patients' lives.   Main Job Tasks and Responsibilities: Ensures the Pharmacovigilance team manages client projects as per the contractual agreements and delivers high-quality services.Collaborates with the Global Head of PV and provides oversight and guidance to global team and delivery centers for projects which include but are not limited to Signal detection and evaluation, Literature Management, Safety Surveillance, Aggregate Reports, Risk Management Plans, ICSRs (PV Case Processing), Audit Support, Safety Management for Clinical Trials, Medical Writing, Other PV SupportBalancing resource requirements across the clients and promoting a pragmatic, flexible, and focused approach to workload.Collaborates and at times initiates process improvement projects by working with global teams.Provides progress of work plans and the status of key project deliverables.Identifies innovative solutions to meet clients' requirements and business objectives in partnership with global delivery teams and SMEs.Monitors, assesses the potential impact develops appropriate strategies for new or emerging regulations, and proposes new service offerings to the management team.Preparing bid-defense response for safety and clinical RFPs.Support sales activities such as bid-defense meetings, new client interactions, capabilities presentations, etc. for safety and clinical projects.Maintains strong relationships with existing clients and has a thorough understanding of our services.Leads/participates in client interactions and governance meetings.Advises on any new technology development and collaborates with internal team/external consultants to support the design and implementation of new technology. Education and Experience:Physician or PharmD or PhD in life sciences.The successful candidate will have 15-20 years of experience in drug safety (ICSR, periodic reporting, safety surveillance is a must) and a working knowledge of key pharmacovigilance regulations and methodologies.Experience in people management.Experience with CRO/BPO is preferred.Broad knowledge of clinical development and/or safety requirements from pre-clinical to post-marketing.Strong leadership skills with a demonstrated track record of successfully managing and leading a diverse and globally distributed team.The Application Process Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.  If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs   please contact mailto:[email protected]@cromsource.com for more information. Who will you be working for?  About CROMSOURCE      CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.                  Our Company Ethos Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry average turnover rates. About TalentSource Life Sciences  TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously. CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status. Keywords: Senior Director, Pharmacovigilance Operations, Senior Director of Pharmacovigilance, Pharmacovigilance Operations, Senior Director, Medical Monitor, Monitor, Clinical Physician, Physician, ICH-GCP, Submissions, Clinical Research, CRO, Clinical Research Organisation, Clinical Trials, Clinical, ICH-GCP, Submissions.Skills: Medical Monitor, Pharmacovigilance Manager, Pharmacovigilance Officer, clinical trials, ICH-GCP, PharmacovigilanceLocation: PolandShare: LinkedIn Facebook Twitter Email
Associate Director (m/w/d) Patient Affairs - Medical HIV
2010 Gilead Sciences GmbH, DE - Munich
For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. We empower our leaders to step up, share ideas, listen, learn, and lead. We’re welcoming bright, diverse, and imaginative minds; we’re nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. Join Gilead and help create possible, together. Job Description Associate Director (m/w/d) Patient Affairs - Medical HIV At Gilead, our vision is to create a healthier world for all people by discovering, developing, and delivering innovative therapeutics for people with life-threatening diseases. From our pioneering virology medicines to our growing impact in oncology, we're delivering innovations once thought impossible in medicine. Because for us the impossible is not impossible. It is what comes next. In the field of HIV, Gilead has been a leading innovator in treatment and prevention of this life-threatening disease. We helped to transform HIV from an inevitably fatal condition to a chronic one that can be well managed by innovative treatments and hence enabling normal life for people living with HIV today. We truly believe in our HIV mission that “Together, we can help end the HIV epidemic for everyone, everywhere”. As Associate Director Patient Affairs HIV you would coordinate and drive our cross-functional engagement to best serve the HIV patient community and patient organizations in Germany. You would be the key responsible person to design, orchestrate and implement patient/community related activities within the German cross-functional HIV team and global Gilead stakeholders. The Associate Director Patient Affairs HIV would report to the Senior Director Medical Affairs HIV. The position is office-based in Martinsried (Munich) and would require travelling on project basis. Key Responsibilities: · Key responsible person to define the overall German HIV strategy for patients, patient advocacy groups and HIV community together with the cross-functional HIV Gilead team. · Key accountable person to create patient-adequate Medical HIV content and to drive and implement non-promotional and unbranded initiatives and tactics. · Deep analysis and understanding of the German HIV patient and patient advocacy group landscape in Germany as well as identification of respective needs and segmentation. · Identification of relevant touchpoints and channels for our communication efforts · Definition of patient and stakeholder journeys considering the omnichannel approach (especially digital/ social media). · Building strong relation and partnerships with leading Patient Advocates, Patient Advocacy Groups as well as other relevant HIV Community Stakeholders in Germany. · Close cross-functional collaboration with other patient-related Gilead stakeholders on national and global level. Job Requirements: At Gilead we believe that team spirit, passion and can-do mindset are the key pre-requisites for success and deeply rooted in our DNA. If you consider yourself being an empathic and purpose driven leader that derives energy by working with others towards a greater mission, you should apply considering the following profile criteria: · Bachelor/Master/PhD/MD degree e.g. in a relevant medical, scientific, health-related, or communication field · Several years of professional experience in the pharmaceutical or health industry, ideally in Patient Affairs, Marketing, Medical Affairs or Market Research Strategy positions · Knowledge in managing digital channels and social media would be a plus · Excellent analytical and strategic thinking as well as strong business acumen · Excellent presentation and communication skills in German and English to experts and to non-experts · Proven track-record of high performance and drive to implement goals and tasks · Experience in project management and budget controlling · Experience and fun to work as informal leader within the matrix and across functions · Can-do mindset and willingness to think outside the box · Excellent team player and inspiring personality Equal Employment Opportunity (EEO) It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws. For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.Über das Unternehmen:2010 Gilead Sciences GmbH
Associate Director* Translational Sciences (limited to 12 months)
BioNTech, Mainz, RP
Open for hire at one of the following locations – Mainz Goldgrube. - Job ID: 5703 Become a member of the BioNTech Family!As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history. We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives. Associate Director* Translational Sciences (limited to 12 months) Key responsibilities Collaborating with a Translational Lead on the development and implementation of program-specific, integrated biomarker strategies from Ph1 to licensure, in alignment with clinical development objectivesContributing to the translation of preclinical results and approaches to clinical biomarker strategies supporting efficient clinical development of the assigned infectious disease assets through data-driven decision making and regulatory complianceAs a member of the cross-functional translational sub-team, partnering with clinical, technical, and scientific colleagues to contribute to the overall biomarker strategy and assist in its executionProvides biomarker and translational contributions to the integrated development plan, clinical development plan, and to regulatory study- or program-related documents such as clinical trial protocols, and -reports, investigator brochures, briefing documents, and market authorization applicationsContributes to the execution of the translational and biomarker strategy in the assigned development program(s) What you have to offer PhD, PharmD, or MD/PhD in Immunology, Biology, Biochemistry, Molecular Medicine, Virology, or a related field with
Market Access Germany Associate Director
0115 Seqirus GmbH, Marburg
We are recruiting an Associate Director Market Access Germany, in which through market access activities the successful candidate will contribute to shape the German market landscape to accept differentiation and create an enhanced positioning for cell-culture and adjuvanted vaccines accepted by payers and by key stakeholders. You will design, develop and implement effective market strategies related to new launches and existing products in the area of pricing and reimbursement, evidence-based medicine review, health technology, and/or health economic modelling (this latter in close collaboration with global and EMEA market access). You will communicate the unique attributes of CSL Seqirus portfolio to external stakeholders to ensure the vaccine's value proposition will be recognized and maximize market uptake. To be successful in this position you will work collectively with national and regional payers, physician associations, pharmacy associations, reimbursement influencers and other decision makers to ensure continuous changing reimbursement systems remain fair to all involved parties and the value of the Seqirus portfolio is recognised. You will actively drive, support and contribute to internal business strategic meetings, budget reviews, HTA submissions, and be the owner of key strategic projects, such as regional and national market access advisory boards, price submissions, health economic analysis and budget impact model tools This role reports to the Country Head DACH, and is a strategic role which requires very close cross-collaboration; locally with medical, marketing, sales teams, and globally with market access team, policy team, Responsibilities include: - Responsible for planning and implementing market access strategy for the Seqirus existing portfolio as well as preparing for new launches Works cross functionally with the country head, with the local marketing, medical and policy colleagues as well as with the global and EMEA market access teams and other key stakeholders to develop the value propositions for the portfolio. Engage key stakeholders as sounding board to validate and optimise the market access strategy Work closely with the global and EMEA market access teams to generate health economic analysis, cost effectiveness and budget impact models in line with the country strategy Provide input into policy shaping dossiers preparation, supporting the achievement of differentiated positioning for the Seqirus innovative vaccines In collaboration with the cross-functional team, generate compelling story flows able to effectively communicate information on product efficacy, on RWE data, on health economics and value propositions to demonstrate advantages of our vaccines Monitors the external environment, customers, and competitors to understand market conditions and identify opportunities to improve value capture. Identify any legislation changes that can have an impact on price and reimbursement and on access in general Input to the future pricing strategy for new launches together with the cross functional team Evaluates pricing and market access risks Take care of annual submission of pricing and price update in the official portals; Builds and maintains relationships with key regional and national key stakeholders, health economic opinion leaders, payers and healthcare groups Engage at regional level with payers, with physician (KV) and pharmacy associations to continue enhance awareness on Seqirus expertise and its portfolio, shape conversations to create acceptance for Seqirus innovative vaccine. Implement strategies and tactics to avoid the barrier of the economic principle, leading as many regions as possible to include cell-culture and adjuvanted under the pricing acceptable new vaccines Ensure frequent meetings with payers and KVs, coordinate meeting to include medical and the GM Develop and execute market access advisory boards, round tables Provide regular update on the changing market access landscape, or new regulations that can affect access keeping the cross-functional team informed Have a close collaboration with EMEA market access and global team, collaborate on the development of HE models, budget impact models and other access tools Create dash boards and update overview to inform the cross-functional team as well as the sales team; collaborate with the regional sales managers and district managers to optimise the communication flow and ensure optimised strategy and results at regional level Input into country strategic meetings, business reviews and budget planning Coordinate market access meetings with medical affairs, ensuring key messages and strategy are always considering the latest stand of the portfolio evidence generation Collaborate closely with policy colleagues and agencies to support achieving a STIKO differentiated recommendation for the Seqirus portfolio Ensure compliance with all internal and external policies, procedures, and regulations e.g., Code of Practice, financial processes Qualifications, skills, and Experience: - Bachelors’ degree in business, health policy, health economics, life sciences or healthcare discipline; 10 years' pharmaceutical industry experience including market access, brand/specialty channel marketing and account management. Must have knowledge of the German healthcare system, relevant legal, compliance and regulatory requirements. Fluent in German and English Holds a driving license valid in Germany. Willing to travel across Germany and internationally according to business needs. Excellent oral and written communication skills in German and English language required. Ability to engage stakeholders at any level Excellent and demonstrated interpersonal skills: Collaborate effectively and demonstrate leadership and teamwork with peers, internal stakeholders and external customers that inspire alignment and partnership on a shared vision or strategy. Be a self-starter, be accountable and have a sense of urgency in delivering results that have payors impact and yield a positive customer experience. Our Benefits We encourage you to make your well-being a priority. It’s important and so are you. Learn more about at CSL. About CSL CSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives through innovation. Learn more about . We want CSL to reflect the world around us As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about at CSL. Do work that matters at CSL! Standort 0115 Seqirus GmbH, Marburg
Associate Director Cost Management (m/w/d) Health Care
Turner & Townsend, Brunswick
Unternehmensbeschreibung Turner & Townsend zählt zu den führenden, globalen Dienstleistungsunternehmen. Mit einem internationalen Netzwerk aus 118 Büros und über Mitarbeitern unterstützen wir private und öffentliche Bauherren und Investoren bei der Steuerung und Realisierung komplexer Bauprojekte und zukunftsorientierter Infrastrukturprojekte. Stellenbeschreibung Zur Erweiterung unseres Management-Teams in Braunschweig suchen wir einen Associate Director Cost Management (m/w/d) Health Care. Sie beraten unsere Kunden hinsichtlich der strategischen Vorgehensweise zur erfolgreichen Realisierung komplexer Neu- und Umbaumaßnahmen im Rahmen eines Großprojektes aus dem Bereich Health Care. Während der gesamten Projektdauer verantworten Sie die Kostenkontrolle und -steuerung, stellen ein effektives Cost-Management bei unseren Kunden sicher und übernehmen Projektleitungsaufgaben. Sie handeln effektiv bei auftretenden Kostenabweichungen im Rahmen des Änderungssteuerungsprozesses. Sie sind ein kompetenter Ansprechpartner und Berater und fördern eine gute und konstruktive Zusammenarbeit mit den kundeninternen Fachbereichen und den Planungsteams in allen Projektphasen. Sie entwickeln eigenständig neue Geschäftsfelder bei bestehenden Kunden, erkennen Cross-Selling sowie weitere Business Developemt-Potenziale. Sie wirken aktiv am Ausbau und der Weiterentwicklung Ihres Teams mit. Qualifikationen Sie haben Ihr Studium in den Bereichen Bauingenieurwesen, Architektur, Wirtschaftsingenieurwesen, Quantity Surveying o.ä. erfolgreich abgeschlossen, MRICS ist ein Plus. Sie verfügen über min. 10 Jahre Berufserfahrung im Projektmanagement oder der Projektleitung von komplexen Hochbauprojekten sowie über vertiefte Erfahrungen im Bereich Baukostenmanagement und in der Mitarbeiterführung. Ein routinierter Umgang mit MS Office und MS Project ist für Sie selbstverständlich. Sie wagen sich gerne an analytisch komplexe Aufgaben und finden durch Ihre analytisch vernetzende und kreative Denkweise stets optimale Lösungen für unsere Kunden. Sie bringen hervorragende Kommunikations- und Präsentationsfähigkeiten in deutscher und englischer Sprache mit und fühlen sich in einem internationalen Arbeitsumfeld sowie mit einer internationalen Kundenstruktur wohl. Zusätzliche Informationen Bei uns finden Sie Ihre berufliche Perspektive innerhalb des internationalen Arbeitsumfeldes. Außerdem können Sie sich auf folgende Leistungen freuen: Spannende Tätigkeit innerhalb eines internationalen Arbeitsumfeldes. Eigenverantwortliches Arbeiten innerhalb eines dynamischen Umfeldes mit herausfordernden Aufgaben. Internationale Entwicklungsperspektiven sowie Weiterbildungsmöglichkeiten. Flexible Arbeitszeitgestaltung und Möglichkeit zum mobilen Arbeiten. Zusatzleistungen wie Fitness Initiativen, Vergünstigte Event- und Kulturhighlights sowie Einkaufsmöglichkeiten oder das Angebot der arbeitgeberfinanzierten Altersvorsorge. Moderne Arbeitsplatz in zentrumsnahen Büros mit guter Verkehrsanbindung. Täglich frisches Obst und Getränke in all unseren Büros. Wir freuen uns auf Ihre Bewerbung. Ihre Ansprechpartnerin: Frau Anne Stoffregen HR Manager Talent Acquistion #LI-AS2 Join our social media conversations for more information about Turner & Townsend and our exciting future projects: It is strictly against Turner & Townsend policy for candidates to pay any fee in relation to our recruitment process. No recruitment agency working with Turner & Townsend will ask candidates to pay a fee at any time. Any unsolicited resumes/CVs submitted through our website or to Turner & Townsend personal e-mail accounts, are considered property of Turner & Townsend and are not subject to payment of agency fees. In order to be an authorised Recruitment Agency/Search Firm for Turner & Townsend, there must be a formal written agreement in place and the agency must be invited, by the Recruitment Team, to submit candidates for review. Standort Turner & Townsend, Brunswick
IT Specialist - System Integration
Komma, Tec Redaction GmbH, Hamburg
IT specialist - system integration System Integrator: in (m/f/d) with a focus on Windows systems Would you like to demonstrate your skills in an interesting industry, are you keen to take on new tasks from Monday to Friday and are you looking for a motivated team in which you can contribute your talent? Then we look forward to getting to know you. May we introduce ourselves? komma,tec redaction works in a spacious loft in Hamburg's Speicherstadt district. We create complete digital signage solutions for our customers. From software, hardware and content consulting to on-site installation, everything from a single source! Since 2005, we have stood for the intelligent combination of IT companies and creative solutions in a still up-and-coming market that can be found everywhere: from industry to conference centers and hotels to town halls. We are proud of our employees, who contribute significantly to our success with their skills and strengths. As a system integrator, you help shape the software that is developed in our company and the digitalization processes of our clients. https://www.youtube.com/watch?v=MMFg4id9fAo What we want from you: Completed training as an IT specialist specializing in system integration, comparable training or at least 3 years of professional experience in an IT department. Career changers welcome! Structured, team-oriented way of working, initiative and organizational talent Very good verbal and written communication skills in German and English Fun with anything that has a plug What you do with us: Your work turns our customers into communication heroes. To make this happen, you will take on the following tasks: Installation and configuration of digital communication systems programmed in-house in various industries and in project work. Arrangement, handover, care and support of our products in the B2B sector. Troubleshooting remotely, by phone or on site. Management and further development of the internal IT infrastructure. You'll love this: A modern, conveniently located workplace in the Speicherstadt warehouse district in the heart of Hamburg Varied tasks with plenty of creative freedom Individual support for your skills and strengths Pleasant working atmosphere in a friendly team Open corporate culture with flat hierarchies Free drinks during working hours an allowance for an HVV season ticket if you like, also joint activities such as cozy dinner rounds, Elbe trips, games or movie nights If you would like to get your own impression of our team and the activities, then get in touch with us in the way that suits you best: A few words about yourself and your qualifications, when you can start and what salary you are looking for by email to our Managing Director Fabian Scholz ( [email protected] ) Give us a call (040 303 75 180) Then you are welcome to come by and get to know us on a trial working day.