Alsinova provides end-to-end life science research services that combine medical expertise with AI-driven tools. As a non-clinical and clinical research company, Alsinova uses a Digital CRO approach, data science, automation, and machine learning to deliver RWE, regulatory affairs, and vigilance support. It operates across 26 countries with flexible collaboration models. Supported by AI and human experts, it tailors solutions for pharma, biotech, and medical device clients. The company targets global life science programs with scalable partnerships.
BioEquivalenceBiostatisticsClinical Data FabricClinical OperationsClinical Project ManagementClinical ResearchConsultingData ManagementData SciencesDecentralized Clinical TrialsDigital EnablementeHealthFSPLife SciencesMedical WritingPhase I to IVQuality AssuranceRegulatoryRWESafetyVigilancealsinova.com
ALSINOVA CRO
Alsinova provides end-to-end life science research services that combine medical expertise with AI-driven tools. As a non-clinical and clinical research company, Alsinova uses a Digital CRO approach, data science, automation, and machine learning to deliver RWE, regulatory affairs, and vigilance support. It operates across 26 countries with flexible collaboration models. Supported by AI and human experts, it tailors solutions for pharma, biotech, and medical device clients. The company targets global life science programs with scalable partnerships.
BioEquivalenceBiostatisticsClinical Data FabricClinical OperationsClinical Project ManagementClinical ResearchConsultingData ManagementData SciencesDecentralized Clinical TrialsDigital EnablementeHealthFSPLife SciencesMedical WritingPhase I to IVQuality AssuranceRegulatoryRWESafetyVigilancealsinova.com
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What We Will Accomplish Together
We will ensure that the Global Pack Management (GPM) Team within Clinical Supply Chain Packaging Operations successfully delivers:
The creation and sourcing of secondary packaging components for all products to be packaged internally within Sponsor ’s clinical trial arena.
The management and control of all label content regulatory requirements and translations within the SMART LS label creation system for all countries/languages where clinical trials are held
The creation and approval of all label content for clinical trial labels across multiple modalities', liaising within 60 plus countries globally, as well as interfacing with Sponsor’s Clinical Interface/CTSM team to determine delivery timescales.
Alsinova Is Looking For An External Label Specialist Within Global Pack Management Who Will Be Tasked With The Creation And Approval Of Label Content For Third Parties For The Following Modalities
Vaccines
Pharmaceuticals (supplies packed external to Sponsor)
Your Mission (should You Decide To Accept It)
The External Label Specialist will liaise with the Clinical Interface/CTSM teams to create the label content and liaise with multiple third party manufacturing/ packaging companies to create and approve the final Clinical Trial labels, using Sponsor Systems such as SMART LS and Prisym. The approved labels will be used for labeling clinical trial supplies packaged at third parties. In addition, the role will have opportunity to cross train in a number of additional areas within GPM. This position will work within a global team....
Your Daily Activities Will Be
You
Our Benefits
Rejoindre Astek, c'est choisir :
un accélérateur d’expérience, où chaque mission est une opportunité de progresser
un accès à une multitude de projets techniquement passionnants pour nos clients comme en interne
un accompagnement de proximité individualisé pour un parcours professionnel sur mesure
un apprentissage continu, grâce à notre Académie de formation interne
un environnement de travail convivial et inclusif, soutenu par des pratiques RH certifiées #TopEmployer2025 Let's move forward.
Working within a global team, create master label content according to existing processes and procedures specific to each modality
Liaise with third party contract manufacturing/ packaging companies to provide label content and receive labels created by the third parties
Perform quality critical checks of label content produced in various languages within the required timelines
Creation of label documentation, required for in-country regulatory submissions, in a timely manner
Perform the translation management role within SMART LS, liaise with third party translation providers
Identify opportunities for process improvement
Ensure quality right first time across all elements of the label creation process
Participate in quality investigation activities (Root Cause Analysis, Product Impact Assessment, Mitigation Action definition), potential to become a business lead investigator Own and implement corrective and preventive actions (CAPAs)
Motivated to self-assign core tasks, prioritizing and completing as part of a wider team with minimal supervision/ input
Work with external vendors, such as translation service provider and third party clinical trial label approvers
Participate in department improvement projects, identify process improvements
Participate in GPM team meetings
Liaise with other groups within Clinical Supply Chain such as Clinical Interface/CTSM and Quality Assurance
Computer or scientific training.
Must have GMP experience, pack and label experience.
Must be very well versed with computer systems.
Must be able to detect errors, compare documents and follow procedures.
Understanding of cGMP requirements and regulatory requirements.
Proficient in Microsoft package and Adobe tools.
Ability to work between multiple GMP IT software systems, adapt to changing systems.
Ability to follow written instructions
Ability to work effectively with others to meet timelines, business goals and objectives.
Excellent verbal and written skills
Ability to work individually as well as part of a team
