About this role:
Do you want to take the next step up in your career? Brunel gives you the chance to continually develop and improve with big-name clients across a broad variety of industries. Take that crucial career step today: Apply to join Brunel as CTSU Packaging & Labeling Expert.
- Autonomously review, check and approval of Master Label Text draft considering regulatory requirements, standard text phrases and trial specifics.
- Autonomously prepare country specific label text for translation of attending countries as well as review and check translated label text considering local requirements and review and check generated print proofs and distribute proofs to countries for check and approval.
- Autonomously work in conjunction with CTSU Trial team, Regulatory Affairs, Global Randomization, Medicine and label vendors to create, define and optimize labeling related tasks.
- Hold PLC internal and external Team and pack & label vendor responsible for keeping their timeline and providing overview on the IMP pack & 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 Expert 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 pack & label vendor. PLC-L Specialist acts as main contact for vendors and countries.
- Contact person for all upcoming questions during the label process.
What you need to bring:
- Experience in Pharmaceutical Industry with a focus on Development and Manufacturing activities or ideally on Clinical Trial Supply Chain activities is required, especially in an international environment, and a good understanding of clinical development processes
- Thorough expertise in pharmaceutical packaging and labeling processes, materials and international regulations
- Master’s Degree with several years of experiences in a relevant area as well as at least 2 years relevant experience in Pharmaceutical industry
- Proven excellent team orientation across international functions including sense of urgency and priority
- Proven ability to interpret complex requirements, associated regulations and highly complex data to drive results in a changing environment
- Capability for fast and focused decision making, including risk assessments, to deliver results, while driving for innovation and improvement
- Excellent written and verbal communication skills: Demonstrated ability to present projects / status reports to different audiences. Fluent in English, spoken and written
- Broad and thorough knowledge and understanding of applicable US and EU regulations and other international regulations, as well as packaging and labelling processes
- Strong computer skills (e.g. Microsoft Office 365, Project Management Software)
Brunel's corporate culture is shaped by the diversity of our people and a commitment to mutual respect between colleagues on every level of the company. That includes a varied program of social get-togethers with your team but also regular feedback sessions with your manager to discuss the challenges you face and your prospects for the future. Personally, tailored training and development create ideal conditions to improve your skills and prepare yourself for future projects. At Brunel: permanent contracts, 30 days' leave, flexible working hours and employer-funded company pension programs are business as usual.
To work for Brunel is to experience attractive work assignments, look forward to positive career prospects, enjoy the secure backing of a growing employer and explore the sheer diversity of the world of engineering and IT. We have more than 40 offices and two development centres in the DACH-CZ region and our 120 offices worldwide employ more than 13,000 people. More than 45 years of international success and over 25 years in Germany – to stand still is to fall behind, so stay on the move with Brunel!
Start applying immediately
Sending an application is quick and easy. Just make sure you have the required documents ready to go.
- Job references (optional)
- Motivation Letter (optional)
Any questions remaining?
Your consultant, Josef Benedikt Stohr is happy to clarify anything about this vacancy. When reaching out, use this number:
Josef Benedikt Stohr
Brunel Germany Lindau
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