Sr. CTS Packaging & Labeling Specialist
Location: King of Prussia
Posted on: June 23, 2025
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Job Description:
Title: Sr CTS Packaging & Labeling Specialist Location: Hybrid
Onsite- King of Prussia, PA or Holly Springs, NC Duration: 6 Months
Initial Contract Compensation: $40 - $49/hr Work Requirements: US
Citizen, GC Holders or Authorized to Work in the US Sr. CTS
Packaging & Labeling Specialist Job Description: Application for
material numbers for the packaging of clinical trial material and
maintenance of material master data. Consultation of the global
study teams in the development of the packaging design of the
studies as an expert for clinical trial packaging. Creation and
maintenance of packaging plans taking clinical demand into account.
Management of the inventory of all packaging components required in
clinical studies. Ordering of materials considering delivery
schedules. Creation of packaging orders in SAP and coordination of
timely processes up to release with global departments. Application
for and processing of kit lists required for the unique
identification of each trial material container (e.g., bottle).
Coordination of the global provision of samples for release testing
after packaging. Ensuring that retention samples are taken from
each packaging order and stored or later destroyed in accordance
with regulatory requirements. Initiation and coordination of
packaging reworks and relabeling (e.g., with new expiry date).
Creation and maintenance of status reports on the packaging of
clinical trial material. Creation of a study-specific label text
template for all packaging units. Provision of translated and
regulatory-compliant label texts for all clinical studies for
submission to the authorities of the participating countries.
Coordination of label printing with internal or external
departments or service providers. Consultation of the global study
teams regarding the development of the label design. Collaboration
with external service providers in maintaining a specific database
for label text translations and regulatory requirements regarding
label content. Support of other global departments (e.g., Global
Commercial Development / Medical Affairs Organization) regarding
the packaging and shipping of clinical trial material for IITs.
Consultation of global departments regarding packaging design and
delivery concept. Coordination with departments and service
providers for the provision of translated label texts, printed
labels, and other required packaging materials. Creation of
packaging orders and ensuring timely delivery. Development, review,
or revision of SOPs, forms, and templates related to the packaging
and labeling of clinical trial material. Processing of Global
Change Control requests Participation in the preparation of audits
and inspections regarding trial material-related topics Processing
of findings from audits and inspections Leading meetings with
global CTS study teams to define the packaging and labeling
strategy. Leading or participating in meetings with external
service providers regarding packaging and labeling issues.
Participation in global study team meetings and meetings.
Qualifications: 2 years' experience in clinical research and/or
clinical supply management or global R&D project management in
the pharmaceutical industry (3 preferred) Knowledge of ICH-GCP
regulations and the conduct of clinical studies Knowledge of cGMP
Note: GxP knowledge is prioritized, SAP experience preferred. At
least basic knowledge of clinical studies is expected. Must be
flexible with working hours in order to allow for global
collaboration (i.e. some early hours will be needed). Not a
strategy/leading position, this is an execution/operational role.
Responsibilities are limited to packaging and labeling, but
knowledge of associated clinical study regulatory environment is
highly preferred. Our benefits package includes: Comprehensive
medical benefits Competitive pay 401(k) retirement plan and much
more! About INSPYR Solutions Technology is our focus and quality is
our commitment. As a national expert in delivering flexible
technology and talent solutions, we strategically align industry
and technical expertise with our clients' business objectives and
cultural needs. Our solutions are tailored to each client and
include a wide variety of professional services, project, and
talent solutions. By always striving for excellence and focusing on
the human aspect of our business, we work seamlessly with our
talent and clients to match the right solutions to the right
opportunities. Learn more about us at inspyrsolutions.com. INSPYR
Solutions provides Equal Employment Opportunities (EEO) to all
employees and applicants for employment without regard to race,
color, religion, sex, national origin, age, disability, or
genetics. In addition to federal law requirements, INSPYR Solutions
complies with applicable state and local laws governing
nondiscrimination in employment in every location in which the
company has facilities
Keywords: , East Brunswick , Sr. CTS Packaging & Labeling Specialist, Science, Research & Development , King of Prussia, New Jersey
