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Global Labeling Delivery Manager - Packaging/Artworks

Kelly Services

Gaithersburg, MD
Job Code:
  • Government
  • Regulatory Affairs
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Job Details

Job Title Global Labeling Delivery Manager - Packaging/Artworks

Jobid US33MXGR_BH1434591

Location: Gaithersburg, MD, 20898, USA

Description Global Labeling Delivery Manager - Packaging/Artworks

Kelly Services is seeking a Global Labeling Delivery Packaging/Artworks Manager for our customer, a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. Based in Gaithersburg, MD, this assignment is budgeted through the end of this year with possibility of extension.

The Global Labeling Group (GLG) is part of Global Regulatory Affairs and focuses on both the preparation and maintenance of labelling documents for prescribing information, patient information and regulatory information on packages for Health Authority approval for products in the EU and US markets.

The Packaging/Artworks Manager is responsible for the regulatory role towards creation of the printed material for products under development, updating of existing artworks for already marketed products and liaising with packaging sites within production.

Job duties include:

+ Point of contact for Regulatory Affairs towards the process for the creation, approval, and implementation of commercial printed labeling in collaboration with various functions
+ Coordinates cross-functional teams in the development and lifetime maintenance of the US and/or EU (centralized) packaging component labeling for all commercial products
+ Provide tactical and strategic guidance to product labeling teams regarding placement and regulatory requirements for regional packaging component labeling content and design
+ Interpret regional labeling regulations and guidance, determining company impact and providing comments as appropriate
+ Interact with Marketing Company colleagues regarding artworks as appropriate
+ Process and prepare US Final Printed Labeling and required EU specimens for submission
+ Assist Global Labeling team in resolution of labeling issues as needed
+ Participate in the development and maintenance of work practices, templates, and associated documents relating to the labeling function
+ Assist in other regulatory activities as required
Minimum experience

+ University Degree in Science or related discipline
+ 3 to 5 years regulatory experience working with labeling
+ Knowledge of labeling regulations and guidances
+ Keen attention to detail and accuracy
+ Excellent verbal and written communication skills in English is necessary
+ Experience in packaging labeling development is highly appreciated but is not a requirement
+ Ability to work collaboratively; work well across formal and informal networks
+ Negotiation skills (good listener; able to build a consensus)
+ Ability to distil an issue to its key components and suggest solutions
+ Multi-cultural awareness and sensitivity; demonstrated experience effectively communicating and negotiating in diverse cultures
+ Ability to think strategically, appropriately assess risks and formulate strategies to manage risk
If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!

**Perks of being a Kelly employee:**

+ Weekly electronic pay
+ Access to more than 3,000 online training courses though Kelly Learning center
+ Group rate insurance options available immediate upon hire*
+ Service bonus plan and holiday pay*
+ Online application system
+ Never an applicant fee
*perks to be received upon meeting eligibility requirements

**Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume. If you have questions, the recruiter for this position can be reached via email at**

**Why Kelly** **®** **?**

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the worlda better place. Let Kelly fuel your career—connect with us today.

**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 connectwith 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 iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.

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