Job Tite: Label Development Specialist Job Location: Ridgefield, CT, 06877 (Hybrid - 2,3 days onsite) Job Duration: 24 Months
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 & 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. Job 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.
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
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $41.67/hr.