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

• 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

You

• 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
• Ability to challenge the status quo
• Capacity to work in a cross cultural environment
• Detailed oriented, high quallity minded
• Must go onsite Collegeville, Philadelphia.

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.