Sr. CTS Packaging & Labeling Specialist Position Available In Montgomery, Pennsylvania

Job Description:

Title:

Sr CTS Packaging & Labeling Specialist Location:

HybridOnsite- King of Prussia, PA or Holly Springs, NC Duration:

6

MonthsInitial Contract Compensation:

$40 – $49/hr

Work Requirements:

USCitizen, GC Holders or Authorized to Work in the US Sr.

CTSPackaging & Labeling Specialist Job Description:

Application formaterial numbers for the packaging of clinical trial material andmaintenance of material master data. Consultation of the globalstudy teams in the development of the packaging design of thestudies as an expert for clinical trial packaging. Creation andmaintenance of packaging plans taking clinical demand into account.

Management of the inventory of all packaging components required inclinical studies. Ordering of materials considering deliveryschedules. Creation of packaging orders in SAP and coordination oftimely processes up to release with global departments. Applicationfor and processing of kit lists required for the uniqueidentification of each trial material container (e.g., bottle).Coordination of the global provision of samples for release testingafter packaging. Ensuring that retention samples are taken fromeach packaging order and stored or later destroyed in accordancewith regulatory requirements. Initiation and coordination ofpackaging reworks and relabeling (e.g., with new expiry date).Creation and maintenance of status reports on the packaging ofclinical trial material. Creation of a study-specific label texttemplate for all packaging units. Provision of translated andregulatory-compliant label texts for all clinical studies forsubmission to the authorities of the participating countries.

Coordination of label printing with internal or externaldepartments or service providers. Consultation of the global studyteams regarding the development of the label design. Collaborationwith external service providers in maintaining a specific databasefor label text translations and regulatory requirements regardinglabel content. Support of other global departments (e.g., GlobalCommercial Development / Medical Affairs Organization) regardingthe packaging and shipping of clinical trial material for IITs.

Consultation of global departments regarding packaging design anddelivery concept. Coordination with departments and serviceproviders for the provision of translated label texts, printedlabels, and other required packaging materials. Creation ofpackaging orders and ensuring timely delivery. Development, review,or revision of SOPs, forms, and templates related to the packagingand labeling of clinical trial material. Processing of GlobalChange Control requests Participation in the preparation of auditsand inspections regarding trial material-related topics Processingof findings from audits and inspections Leading meetings withglobal CTS study teams to define the packaging and labelingstrategy. Leading or participating in meetings with externalservice providers regarding packaging and labeling issues.

Participation in global study team meetings and meetings.

Qualifications:

2 years’ experience in clinical research and/orclinical supply management or global R D project management inthe pharmaceutical industry (3 preferred) Knowledge of ICH-GCPregulations and the conduct of clinical studies Knowledge of c

GMPNote:

GxP knowledge is prioritized, SAP experience preferred. Atleast basic knowledge of clinical studies is expected. Must beflexible with working hours in order to allow for globalcollaboration (i.e. some early hours will be needed). Not astrategy/leading position, this is an execution/operational role.

Responsibilities are limited to packaging and labeling, butknowledge of associated clinical study regulatory environment ishighly preferred.

Our benefits package includes:

Comprehensivemedical benefits Competitive pay 401(k) retirement plan and muchmore! About INSPYR Solutions Technology is our focus and quality isour commitment. As a national expert in delivering flexibletechnology and talent solutions, we strategically align industryand technical expertise with our clients’ business objectives andcultural needs. Our solutions are tailored to each client andinclude a wide variety of professional services, project, andtalent solutions. By always striving for excellence and focusing onthe human aspect of our business, we work seamlessly with ourtalent and clients to match the right solutions to the rightopportunities. Learn more about us at inspyrsolutions.com. INSPYRSolutions provides Equal Employment Opportunities (EEO) to allemployees and applicants for employment without regard to race,color, religion, sex, national origin, age, disability, orgenetics. In addition to federal law requirements, INSPYR Solutionscomplies with applicable state and local laws governingnondiscrimination in employment in every location in which thecompany has facilities