TalentBurst | Label Development Specialist CT | ridgefield, ct
1 day ago
Duration: 12 Months (Possible Extension)
Location: Hybrid - Ridgefield CT (06877)
Duties:
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.
#TB_PH
-
Label Development Specialist CT
2 weeks ago
Ridgefield, CT, United States TalentBurst Full timeTitle: Label Development Specialist Duration: 12 Months (Possible Extension) Location: Hybrid - Ridgefield CT (06877) Duties: 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...
-
Ridgefield, CT, United States TalentBurst Full timeScientist II Ridgefield CT 06877 2 Years Description: We are seeking a highly skilled and motivated scientist at the Scientist II level to join our Immunology and Respiratory Disease Department located in Ridgefield, CT. The successful candidate, with a demonstrated ability to work in a matrix environment, will work within the Translational Biology group to...
-
Label Development Specialist CT
2 weeks ago
ridgefield, United States TalentBurst Full timeTitle: Label Development Specialist Duration: 12 Months (Possible Extension) Location: Hybrid - Ridgefield CT (06877) Duties: 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...
-
Label Development Specialist CT
2 weeks ago
Ridgefield, United States Talentburst Full timeTitle: Label Development SpecialistPlease ensure you read the below overview and requirements for this employment opportunity completely. Duration: 12 Months (Possible Extension) Location: Hybrid - Ridgefield CT (06877) Duties: The Label Development Specialist is accountable for processing, planning, monitoring, and steering of timelines, tasks and costs...
-
Label Development Specialist CT
1 week ago
ridgefield, United States TalentBurst Full timeTitle: Label Development Specialist Duration: 12 Months (Possible Extension) Location: Hybrid - Ridgefield CT (06877) Duties: 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...
-
ridgefield, United States TalentBurst Full timeScientist II Ridgefield CT 06877 2 Years Description: We are seeking a highly skilled and motivated scientist at the Scientist II level to join our Immunology and Respiratory Disease Department located in Ridgefield, CT. The successful candidate, with a demonstrated ability to work in a matrix environment, will work within the Translational Biology group to...
-
Ridgefield, CT, United States TalentBurst Full timeBusiness Analyst I Ridgefield CT 06877 - Fully Remote 6 Months Duties: Actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success....
-
Ridgefield, CT, United States TalentBurst Full timeTitle: Admin Assistant ILocation: Ridgefield CT 06877 (Hybrid)Duration: 12 Months They must be able to come onsite 3 days a week and Wednesday is a mandatory onsite day. Duties: This person will be working on travel and expenses for the majority of their work. They need to have strong experience in that area. If they have experience using the system concur...
-
Ridgefield, CT, United States TalentBurst Full timeTitle: Admin Assistant I Location: Ridgefield CT 06877 (Hybrid) Duration: 12 Months They must be able to come onsite 3 days a week and Wednesday is a mandatory onsite day. Duties: This person will be working on travel and expenses for the majority of their work. They need to have strong experience in that area. If they have experience using the system...
-
Ridgefield, United States TalentBurst Full timeBusiness Analyst I Ridgefield CT 06877 - Fully Remote 6 Months Duties: Actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success....
-
ridgefield, United States TalentBurst Full timeBusiness Analyst I Ridgefield CT 06877 - Fully Remote 6 Months Duties: Actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success....
-
ridgefield, United States TalentBurst Full timeTitle: Admin Assistant I Location: Ridgefield CT 06877 (Hybrid) Duration: 12 Months They must be able to come onsite 3 days a week and Wednesday is a mandatory onsite day. Duties: This person will be working on travel and expenses for the majority of their work. They need to have strong experience in that area. If they have experience using the system...
-
Ridgefield, United States TalentBurst Full timeTitle: Admin Assistant I Location: Ridgefield CT 06877 (Hybrid) Duration: 12 Months They must be able to come onsite 3 days a week and Wednesday is a mandatory onsite day. Duties: This person will be working on travel and expenses for the majority of their work. They need to have strong experience in that area. If they have experience using the system...
-
ridgefield, United States TalentBurst Full timeTitle: Admin Assistant I Location: Ridgefield CT 06877 (Hybrid) Duration: 12 Months They must be able to come onsite 3 days a week and Wednesday is a mandatory onsite day. Duties: This person will be working on travel and expenses for the majority of their work. They need to have strong experience in that area. If they have experience using the system...
-
TalentBurst | Business Development
1 week ago
ridgefield, United States TalentBurst Full timeBusiness Development & Continuity Expert - Program Manager II Ridgefield CT, 06877, Hybrid schedule 2 Years Duties: The Business Development & Continuity Expert represents the Pharmaceutical Development department in audits and inspections by global regulatory authorities, collaborating cross-functionally with various global partners. They independently...
-
Education Specialist
1 week ago
Ridgefield, Connecticut, United States ProCare Therapy Full timeJob OverviewProCare Therapy is a leading provider of mental health services, and we are seeking a highly skilled Education Specialist to join our team in Ridgefield, Connecticut.Salary and BenefitsThe salary for this position is competitive, with an estimated annual compensation of $85,000 - $110,000 based on experience and qualifications. Our comprehensive...
-
Label Development Specialist
1 month ago
Ridgefield, United States SPECTRAFORCE Full timeJob Tite: Label Development SpecialistJob Location: Ridgefield, CT, 06877Job Duration: 24 MonthsPay Rate starts from $40/hr on W2 (Negotiable)Job Description: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 &...
-
Physiatrist Opportunity in Ridgefield, CT
1 week ago
Ridgefield, Connecticut, United States Medrina Full timeOverviewMederina is seeking a skilled Physiatrist to join our team at our location in Ridgefield, CT. The ideal candidate will have experience in managing patients with physical disabilities and chronic conditions.
-
Ridgefield, Connecticut, United States TalentBurst Full timeAbout the RoleAs a Senior Labeling Specialist at TalentBurst, you will play a key role in ensuring timely and accurate labeling of medical products for global clinical trials. This is an exciting opportunity to leverage your expertise in clinical trial regulations, packaging, and labeling to drive business growth.
-
Scientist II CT
5 days ago
ridgefield, United States TalentBurst Full timeScientist II Ridgefield CT 06877 2 Years Description: We are seeking a highly skilled and motivated scientist at the Scientist II level to join our Immunology and Respiratory Disease Department located in Ridgefield, CT. The successful candidate, with a demonstrated ability to work in a matrix environment, will work within the Translational Biology group to...
