Job Title: Label Development SpecialistLocation: Ridgefield, CT (Hybrid)Duration: 2 YearsDuties:The Label Development Specialist is accountable for processing, planning, monitoring and steering of timelines, tasks and costs for labeling activities performed at internal or at the packaging & labeling vendor supporting global clinical trials phase I - IV. The Label Development Specialist ensures within the Global Trial Team the timely provision of all kinds of IMP labels for assigned trials by communicating and negotiating all labeling related activities.Tasks & Responsibilities:
- Autonomously review of Master Label Text drafts considering regulatory requirements, standard text phrases and trial specifics.
- Autonomously prepare country specific label text for translation of attending countries.
- Autonomously review and check translated label text considering local requirements.
- Autonomously review and check generated print proofs and distribute proofs to countries for check and approval.
- Autonomously work in conjunction with global Trial Teams, Regulatory Affairs, Medicine and label vendors to create, define and optimize labeling related tasks.
- Hold PLM internal and external team and pack & label vendors responsible for keeping their timeline and providing overview on the IMP pack & label milestones to the global 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. PLC-L Specialist acts as main contact for vendors and countries.
- Contact person for all upcoming questions during the label process.
Summary of the above items as follows:
- Autonomously generation, preparation and review of Master Label Text, country specific label text and print proofs considering regulatory requirements,
- Autonomously collaboration in conjunction with global Trial Teams, Regulatory Affairs, Medicine and Label Vendors to create, define and optimize labeling related tasks,
- Is responsible for keeping the timeline and providing overview of label generation related milestones as well as ensure appropriate and effective communication to all functions,
- Compile and provides complete label documentation for final release,
- Is the main contact for all upcoming questions during label process.
Skills:Requirements:
- Background in Clinical Trials (Supply Chain, Clinical Trial Regulations, Packaging and Labeling area, medical documentation)
- Experience with labeling needs & processes i. e. Food industry
- 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
- Strong computer skills (e. g. Microsoft Office)
- Fluency in English
.Education:
- Master's Degree with experience in a related field or professional training with extensive experience in a related field