11 days old

Label Coordinator (regulatory)

Kelly Services
Lansdale, PA 19446
Every day, Kelly Services connects professionals with opportunities to advance their careers. We currently have an exciting 3+ year, long term contract benefitted opportunity as a Label Coordinator / Translation Coordinator for a top fortune 500 company in West Point PA.

**Title:** Label Coordinator / Translation Coordinator

**Duration:** 3+ years

**Location:** West Point PA

**Pay rate:** $23/hr

Team member will be responsible to read, comprehend, and translate clinical trial protocols / packaging specifications into clinical label generation software. Individual will design clinical supplies trial labels for primary, secondary, and auxiliary packaging applications within the client label systems. Individual will interpret randomization schemes, input into label software system, and utilize system to verify correct labels are produced according to cGMPs.

**Essential Duties and Responsibilities:**

+ Coordination the translation of required label text from English into other languages as required to support clinical trial protocols.

+ Generate clinical label proofs or review label proofs created by external providers

+ Liaise with country-level Clinical Operations personnel or Regulatory Affairs to address question, revise translations, update regulatory requirements on clinical supplies labels

+ Maintain Label Translations library in client label systems

+ Interpret clinical study design and create labels for application to clinical trial materials

+ Design and verify label models in client label systems

+ Coordinate multi-lingual booklet label manufacturing at vendors

+ Perform visual inspection and accountability for label proofs and clinical labels

+ Participate in complaint and deviation investigations and creation Corrective and Preventative actions (CAPA's). Drive CAPA's to closure.


+ Proficient in Microsoft Office suite

+ Strong attention to detail

+ Strong verbal and written communication skills

+ Strong organizational skills, ability to prioritize and ability to multi-task

**Education / Experience:**

+ Minimum of an Associates degree, Bachelors degree preferred

+ 5 years of related pharmaceutical labeling/ packaging experience preferred

**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States. Please contact Michelle Niemira ( ) for immediate consideration.

**This position comes with enhanced benefits which include:**

+ 50/50 shared healthcare cost (Kelly pays 50% of the monthly premium, employee pays 50%)*

+ Paid holidays

+ Paid sick days and vacation days*

**Perks of being a Kelly employee:**

+ Weekly electronic pay

+ Access to more than 3,000 online training courses though Kelly Learning center

+ Online application system

+ Never an applicant fee

*benefits to be received upon meeting eligibility requirements

**Why Kelly** **** **?**

At Kelly
Services , we work with the best. Our clients include 95 of the Fortune
100 companies, and more than 70,000 hiring managers rely on Kelly annually to access
the best talent to drive their business forward. If you only make one career connection today, connect
with Kelly.

**AboutKelly Services** ****

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people
around the world and have a role in connecting thousands more with work through our global network of
talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connect with us on Facebook, LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.


Posted: 2019-02-11 Expires: 2019-03-14

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Label Coordinator (regulatory)

Kelly Services
Lansdale, PA 19446

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