Pharmaceutical Project Manager with a Labeling Focus (m/f/d) - Remote possible

Akkodis - formed by the merger of AKKA & Modis - is a global leader in Engineering & IT. As a global partner in an ever-changing technology & competitive environment, we support our customers with our 360 offering to create a more sustainable & smarter future.

United by our shared passion for technology & talent, we look at the world from a new perspective. Every day, our 50,000 motivated engineers & digital experts go beyond the possible to create the incredible.

At Akkodis Life Sciences, we manage projects nationwide for renowned clients in the pharmaceutical, biotech, and chemical industries.

From start-ups and family-owned businesses to medium-sized companies and global industry leaders, we cater to a diverse range of clients and requirements.

We are currently seeking a Pharmaceutical Project Manager with a Labeling Focus (m / f / d) for our esteemed client in the pharmaceutical and biotech sector.

Start : ASAP

Location : Greater Biberach area

Employment Type : Full-time

Duration : 18 months

Position Level : E12T

What you can do for us

• Independently assess Master Label Text drafts, ensuring alignment with regulatory guidelines, standard phrases, and specific trial needs
• Independently develop country-specific label texts to be translated for participating countries
• Independently review and validate translated label texts, ensuring they meet local regulatory standards
• Independently examine and approve print proofs, coordinating their distribution to countries for review and approval
• Collaborate closely with CTSU Trial teams, Regulatory Affairs, Global Randomization, Medical departments, and label vendors to establish, refine, and streamline labeling tasks
• Maintain accountability of PLC teams, both internal and external, as well as pack and label vendors, to adhere to timelines and keep the CTSU trial team updated on IMP pack and label milestones, fostering clear communication across all functions
• Gather and provide complete label documentation, submitting it for final approval to the Release and Process Management Team.
• Serve as the primary contact for vendors and countries, supplying essential documents, including the Master Label Text, Country List, Packaging Design, STORM Document, and any other required product or country-specific information
• Act as a go-to resource for any questions that arise throughout the labeling process

The skills that are needed

• A Master’s degree with several years of experience in a relevant field, or vocational training with extensive related experience
• Solid background in Clinical Trials, particularly in areas such as Supply Chain, Clinical Trial Regulations, Packaging and Labeling, and medical documentation
• Experience with labeling requirements and processes, ideally from fields like the food industry
• Proficiency in all aspects of clinical supply chain activities, with a strong understanding of applicable regulations (such as CTR 536 / 2014)
• Robust project management abilities
• Capability to interpret both standard and complex project requirements
• Strong skills in problem-solving, risk assessment, and troubleshooting
• Ability to work autonomously as well as within a global team
• Proficiency in computer skills, including Microsoft Office
• Fluency in English

Why you are in the right place when working with us

• Remote possible : there is the possibility to work partly in the home office / remote (2-3 days per week) and thus to benefit from the advantages of hybrid work (flexible working)
• Team spirit and diversity
• Work-life balance
• Attractive remuneration
• Employee benefits
• Numerous opportunities for training
• Team and sports events
• Global network
• Attractive employee referral program

Benefits may vary based on position and location. You can find an overview of our benefits under Careers and Benefits on our website.

We are looking forward to getting to know you.

Send us your application directly. We'll be happy to answer any questions you may have. We welcome applications from people who contribute to the diversity of our company.

Your Contact

Herr Benjamin Risch

[email protected]

Akkodis Germany Tech Experts GmbH

Life Science

Talstraße 4

79102 Freiburg

Phone +49 761 38908002

www.akkodis.com / de