Label Development Specialist (f/m/x) für Biberach an der Riß gesucht

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Job Kategorie: Medizin/Pharma/Biotech Sekretariat/Assistenz/Office Management

Stellenangebot Basisdaten

Arbeitsort:: DE 88400 Biberach an der Riß
Umkreis:: keine Angabe.
Art der Arbeitsstelle:
Letze Aktualisierung:: 26.11.20242024-11-26

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Stellenausschreibung: Label Development Specialist (f/m/x)

Arbeitgeber bzw. Arbeitsvermittler: Randstad Deutschland in Kamen

Branche: Medizin/Pharma/Biotech

Kategorie: Sekretariat/Assistenz/Office Management

Stellenbeschreibung: Don't settle for second best? Then Randstad is the right choice for you because as the number one German personnel service provider, we always offer a little extra compared to others: competitive salary, Christmas and vacation bonuses, shopping discounts, and free training opportunities. Take your next career step with us and apply for the attractive position as a Label Development Specialist at our client's location, a pharmaceutical company in Biberach. We explicitly welcome applications from individuals with disabilities! Das dürfen Sie erwarten - Attractive salary based on the BAP/DGB collective agreement - The possibility of partial payments - Attractive social benefits, such as vacation and Christmas bonuses - Representation by a nationwide central works council - Possibility to work from home for 2-3 days per week - Free work safety clothing and regular preventive medical checkups - A wide range of employee benefits/perks - Thorough induction/training provided by our client company - Challenging projects and diverse tasks in an international environment Ihre Aufgaben - Autonomously review of Master Label Text drafts considering regulatory requirements, standard text phrases and trial specifics - Prepare country specific label text for translation of attending countries - Review and check translated label text considering local requirements - Review and check generated print proofs and distribute proofs to countries for check and approval - Work in conjunction with CTSU Trial teams, Regulatory Affairs, Global Randomization, Medicine and label vendors to create, define and optimize labeling related tasks - Hold PLC internal and external Team and pack and label vendors responsible for keeping their timeline and providing overview on the IMP pack and label milestones to the global CTSU trial team as well as ensures appropriate and effective communication to all functions - Compile and provide completed label documentation for final release to the Release and Process Management Team - Global PLC-L Specialist provides all relevant Documents like Master Label Text, Country List, Packaging Design, STORM Document and all other country and product specific information necessary to perform this task by external vendors - Contact person for all upcoming questions during the label process Unsere Anforderungen - Master’s Degree with several years of experience in a related field or professional training with extensive experience in a related field - Background in Clinical Trials e. g. Supply Chain, Clinical Trial Regulations, Packaging and Labeling area, medical documentation - Experience with labeling needs & processes i. e. Food industry - Strong computer skills e. g. Microsoft Office - Fluency in English - Demonstrates knowledge of all areas of clinical supply chain activities and a thorough knowledge and understanding of applicable regulations e. g. CTR 536/2014 - Solid project management skills - Ability to interpret standard and complex project requirements - Strong problem solving, risk assessment and troubleshooting skills - Work independently and in a global team environment

Qualifikation: Arbeitskräfte

Verdienst:: 5300.00 - 5400.00 EUR

Bewerbung an: Randstad Deutschland
Lünener Straße 211-212
De 59174 Kamen
Telefon: +49 1525 4509064
Email: talent@randstad.de

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