Global Label Business Analyst (all genders) (full-time / part-time) (Biowissenschaftler/in)

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Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

Your Role:

“Translating strategy into action” is our motto. In your role as a Global Label Business Analyst (all genders), your focus area will be the system design, programming, and the implementation of changes to enhance the label system used in Darmstadt. Thereby, you will serve as a vital link between Business and IT, translating requirements into clear and testable specification documents. You will lead the lifecycle from business requirements to deployment by following the guidelines of Computer System Validation (CSV) in a highly regulated environment.

Moreover, you will support the head of Global Management (GLM) in implementing the global label strategy across Life Science. In doing so, you will work on integrating diverse label solutions connected to SAP and ensure they meet operational processes, as well as quality and regulatory requirements for labelling. As part of the Digital Transformation Group, you will have the opportunity to contribute your technical expertise and collaborate with our digital and data science community.

Who You Are:

- Bachelor or master’s degree in Life Sciences, Data Science, IT or related discipline
- Programming skills (e.g., Python) are a must
- 2
- years of experience in pharma, medical device, or chemical industry
- Proficient in ERP Systems such as Oracle or SAP
- Comfortable working in complex environments within multi-cultural and multidisciplinary teams
- Excellent communication and project management skills
- Very good knowledge of English, good knowledge of German is a plus
- Experience with Palantir, and label platforms (e.g., Loftware) are a plus

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of our diverse team!

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Work Your Magic with us! Start your next chapter and join EMD Serono.

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your role:  As Imaging Operations Lead you will provide leadership and expert input into all imaging operations aspects at the trial, program and/or portfolio level.  Our imaging capabilities include all modalities with a focus on CT, MRI and PET in various therapeutic areas including oncology, neurology and immunology. You will work closely with cross-functional leads for assigned trials, internal and external business partners, imaging vendors, Head of Specialty Operations and other Global Development Operations leaders to design and deliver our clinical trials with speed, quality and efficiency as follows:

- Drive with internal and external business partners, the development of the Operational Clinical Trial Imaging Strategy Plan at trial level across Phase I-IV, that is in line with our strategic imperatives and priorities
- Provide expert imaging operations input from protocol development, vendor selection to execution of the imaging component of the clinical trials
- Drive and lead the successful execution, oversight and approval of imaging trial document plans, imaging read schedules and workflow for assigned trials
- Lead imaging vendor(s) governance meeting and member of the Imaging Center of Excellence, as well as ad hoc engagements to maintain high performance and address immediate issues and risk mitigation
- Serve as the point of escalation to clinical trial teams (CTT) and facilitate resolution of issues
- Accountable for the imaging operations performance and quality metrics at trial/program/portfolio level and identify trends, issues, and risks. Work closely with CTT, internal and/or external business partners to ensure mitigation plans are defined and implemented
- Identify gaps within the processes (either internal or external), which may impact key deliverables (timelines/ quality/costs) and work closely with internal and/or external business partners to ensure action or mitigation plans are defined and implemented at portfolio level
- Accountable for raising awareness of such trends/issues/gaps in imaging processes and facilitate solutions, working closely with relevant internal and/or external partners, ensure CAPA are defined and implemented. Raise awareness of trends/ issues (within and across program) with key internal/external partners, department leader and/or senior management as appropriate
- Contribute to imaging excellence by providing training to CTTs on trial imaging related aspects and lead and/or contribute to related process improvements and standardization of documents
- Keep up to date with imaging related innovations, technologies, vendors, regulatory changes and lead or contribute to continuous improvement initiatives

Location: Billerica, MA Hybrid.

Position can be located in Germany, UK, or Ireland.

Who You Are:

Minimum requirements

- BS degree and 5- 8 years of experience or MS degree with 3-6 years of experience, or PHD 2-5 years of experience in imaging or related life-science
- Experience in clinical research in a CRO or Pharmaceutical/Biotechnology Industry environment.
- Clinical trials imaging operations experience.

Preferred Requirements

- You have experience in imaging CRO oversight and implementing quality control measures
- You have experience working in multiple therapeutic areas (including in oncology), phase II and/or III clinical trials from start-up to close-out
- You work efficiently in a fast-paced, collaborative, matrixed, multinational work environment
- You do not shy away from challenging the status quo, you bring new ideas forward and strive to raise the bar
- You are passionate about making an impact on people’s lives by helping bring more medicines, to more patients, faster
- You have a data driven and end to end mentality and make data driven and risk-based decisions
- You have excellent interpersonal skills, and you influence others without authority
- You build and maintain effective relationships with internal and external partners

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of our diverse team!

If you would like to know more about what diversity, equity, and inclusion means to us, please visithttps://www.emdgroup.com/en/company/press-positions.html

Inside Sales Graduate Entwicklungsprogramm (m/w/d) Supply Chain Management 2024

Als weltweit führendes Unternehmen im Dienste der Wissenschaft unterstützen wir unsere Kunden im Bereich der biowissenschaftlichen Forschung, bei der Erarbeitung der Lösung komplexer analytischer Herausforderungen, der Steigerung der Produktivität, der Verbesserung der Patientengesundheit bis hin zur Entwicklung und Herstellung von lebensverbessernden Therapien. Unser globales Team aus mehr als 100.000 Kollegen – und Kolleginnen bietet eine unübertroffene Kombination aus innovativen Technologien, komfortablen Einkaufsprozessen und pharmazeutischen Dienstleistungen bestehend aus den Marken Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon und PPD.

Möchten Sie Teil unserer einzigartigen Mission werden „unsere Kunden dabei zu unterstützen, die Welt gesünder, sauberer und sicherer zu machen“? Dann bewerben Sie sich noch heute!

Standort: Hybrid – Back-office Arbeit Darmstadt/Hessen + Vor-Ort-Kundensupport (Deutschland/Österreich/Schweiz)

Dauer: 12 Monate

Der erfolgreiche Kandidat wird in Zusammenarbeit mit unserem kommerziellen und E-Business-Team daran arbeiten, unser Vor-Ort-Supply Center Programm bei einigen unserer größten akademischen, biotechnologischen und pharmazeutischen Kunden zu optimieren.

Verantwortungsbereich
Unser Supply-Center-Programm ermöglicht es unseren Kunden, ihre essentiellen Produkte für ihre Forschung und anstehenden Aktivitäten direkt vor Ort zur Verfügung zu haben. Es spielt eine entscheidende Rolle bei der Gewährleistung eines effizienten Warenflusses innerhalb einer Lieferkette.

In Ihrer Graduate-Funktion unterstützen Sie die Aktivitäten des Supply Centers sowohl im Innen- als auch im Außendienst, um ein außergewöhnliches Kundenerlebnis sicherzustellen. Ihre Verantwortlichkeiten umfassen die Optimierung und Aufrechterhaltung der Bestände im Supply Center sowie die Unterstützung von Marketing-Initiativen. Sie werden ermutigt, Bestandskontrollen, Produktausstellungen, Seminare, Vor-Ort-Angebote und andere Werbeveranstaltungen im Zusammenhang mit dem Supply Center durchzuführen und daran teilzunehmen.

Sie arbeiten eng mit unseren Kunden, eBusiness-Projektmanagern, Vertriebsteams und dem Kundenservice zusammen, um das Wachstum des Supply Center-Kanals zu fördern. Starke Kommunikationsfähigkeiten und Proaktivität sind erforderlich, um regelmäßige Feedbackgespräche zu führen, die Aktivitäten unserer Konkurrenz zu überwachen und Möglichkeiten zur Verbesserung unserer Geschäftsbeziehungen sowohl intern als auch extern zu teilen.
Während Ihrer Tätigkeit werden Sie in vielen unserer Systeme geschult, darunter das bevorzugte Bestellsystem und SCMS, unser Supply Center Management System. Zudem bieten wir Ihnen die Möglichkeit, an Vertriebsschulungen teilzunehmen, um Ihr Produktwissen zu verbessern und sich weiterzuentwickeln.

Ausbildung und Erfahrung:
Sie sollten über einen Bachelor-Abschluss in Bereich Biowissenschaften oder einem verwandten Bereich verfügen. Frühere Verkaufserfahrungen sind von Vorteil, aber nicht zwingend erforderlich. Unsere Supply Center Spezialisten sollten einen kundenorientierten Ansatz verfolgen und über ein ausgeprägtes Bewusstsein für Märkte, Trends und Wettbewerber verfügen. Eigenschaften die Sie für diese Stelle mitbringen sollten sind Neugier, eine zielorientierte Denkweise, ein hohes Maß an Motivation sowie eine „Can-do“ Mentalität.

Voraussetzungen :

- Durchführung von Bestandskontrollen vor Ort oder aus dem Back-Office (Abhängig von Kundenanforderungen)
- Erfordert durchschnittlich 75% Reiseaktivität
- Akquise neuer Kunden um unseren Foodprint zu erhöhen
- Förderung des Vor-Ort Supply Center Programms
- Bei der Bestandspflege vor Ort kann es erforderlich sein, bis zu 20 kg zu heben.
- Es kann erforderlich sein, bei der Ausführung von Arbeitsaufgaben längere Zeit zu stehen
- Muss in der Lage sein, sicher mit Chemikalien und gefährlichen Materialien zu arbeiten
- Eigenständige Arbeitsweise und Proaktivität erforderlich
- Fließend in Deutsch und Englisch (Minimum B2)

Was wir bieten:

- Hervorragende Entwicklungs- und Karriereperspektiven in einem weltweit wachsenden Unternehmen
- Eine Unternehmenskultur, in der Integrität, Engagement, Intensität und Innovation im Vordergrund stehen
- Flexibilität: 2 Tage Homeoffice/ 3 Tage im Büro (Darmstadt)
- Individuelle Schulungen und Weiterbildungen in unserer Thermo Fisher University
- 30 Urlaubstage

Haben wir Ihr Interesse geweckt?

Möchten Sie Ihre Zukunft gemeinsam mit uns gestalten, dann freuen wir uns auf Ihre Bewerbung. Sie können sich nur online über unsere Karriereseite mit vollständigen Bewerbungsunterlagen (Motivationsschreiben, Lebenslauf und Schulzeugnisse) bewerben.

Thermo Fisher Scientific ist ein EEO/Affirmative Action Arbeitgeber und diskriminiert nicht aufgrund von Rasse, Farbe, Religion, Geschlecht, sexueller Orientierung, Geschlechtsidentität, nationaler Herkunft, geschütztem Veteranenstatus, Behinderung oder einem anderen gesetzlich geschützten Status.

Apply today!http://jobs.thermofisher.com

Agency notice!

Please note we are not interested in receiving unsolicited CVs from any personnel service providers. Should you choose to send us or upload any such candidate document they will not be acknowledged and will be deleted in line with our privacy policy.

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Work Your Magic with us!


Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.


Your role:

An exciting opportunity awaits you within the Patient Focused Real World Evidence (PRWE) Team. As passionate leaders of patient focused real world data, evidence generation, and epidemiology, we are uniquely placed to enable fit-for-purpose visionary solutions with real world and patient focused data from early development and throughout the drug life span. Our team operates with a proactive and agile approach, as a trusted partner in qualitative and quantitative sciences, all while striving towards the common goal to deliver more medicines to more patients faster.

As a key member of our team, you will drive the Real-World Evidence and Data (RWE/D) strategy and studies across the lifecycle of drugs, with a particular focus on drug development and excellence in integrated evidence planning. You will provide scientific leadership and expertise to ensure that fit-for-purpose RWD are integrated in evidence generation plans and available in a timely manner to support regulatory submissions and program´s decision-marking.

You will lead the design, implementation and oversight of disease or drug-specific Non-Interventional (NIS) / RWE studies, encompassing safety related studies, external control arm studies, and regulatory grade studies. Your work will involve inspiring cross-functional collaboration, in a unique partnership with other quantitative scientists while maintaining and expanding our external collaborations.

Who you are:

- Preferably a background in health and life sciences (MD, pharmacist epidemiology, public health), or quantitative data sciences, biostatistics
- Doctoral and/or master’s degree (e.g., PhD, MSc) in Epidemiology, Public Health or related field
- Strong experience in RWE/D within the pharmaceutical industry, particularly in the application of RWE in drug development for rare indications
- Demonstrable experience in leading RWE generation plans and studies end-to end, including application of innovative designs and methods
- Excellent oral and written communication skills and demonstrated ability to engage and communicate scientific evidence to peers and at scientific meetings
- Collaborative, proactive working style, with ability to work independently.


What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of our diverse team!

.


Work Your Magic with us!


Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.


United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.


Your Role: Are you looking for an exciting opportunity where you can make a significant impact on clinical development programs? Join our team as a Senior Bioanalytical Operations Manager (BAOM) and contribute to the success of our innovative NBE/NCE and ADC clinical development initiatives. As the BAOM, you will play a crucial role in the BioSample Operations group within Global Development Operations. You will provide scientific and technical oversight while ensuring the smooth execution of operational processes and delivery of clinical bioanalytical data from our trusted Contract Research Organization (CRO) partners. Your expertise will directly support the advancement of our clinical programs. This role can be based flexible in EMEA region; remote working possible.


Main Responsibilities:

- Represent the BioSample Operations group on multiple clinical study teams, addressing requests related to Pharmacokinetic (PK) and immunogenicity data.
- Oversee scientific and technical aspects, including the review of raw PK concentration results, immunogenicity data, and bioanalytical reports.
- Ensure efficient sample flow and data transfer processes for clinical PK and immunogenicity studies.
- Support contracting activities with bioanalytical CROs, including contract execution, change orders, and document filing.
- Assist in budget planning for outsourced bioanalytical and validation studies.
- Support publication of bioanalytical study reports in the regulated database.
- Facilitate document filing for inspection readiness.
- Ensure compliance with timelines, quality standards, guidelines, and internal protocols in outsourced bioanalytical studies.
- Organize meetings and maintain meeting minutes.


Who You Are:

- Ph.D., Master's, or Bachelor's degree in biomedical sciences or related fields, coupled with 5
- years of post-graduate experience in the life sciences industry.
- Experience in clinical PK and immunogenicity sample analysis, such as LC-MS/MS, ELISA.
- Regulatory knowledge of clinical PK bioanalysis is a plus.
- Experience in clinical study management is an advantage.
- Familiarity with bioanalytical CRO partnerships is desired.
- Working experience in a GLP or GCP regulated environment.
- Good understanding of drug development and discovery processes is beneficial.
- Proven project coordination and/or project management experience.
- Proficiency in Microsoft, knowledge of Microsoft Project Planning software is a plus.
- Ability to communicate effectively at all hierarchies.
- Intercultural understanding; used to act in a global matrix organization.
- Fluent spoken and written English is required.


What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of our diverse team!