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Global Labeling Delivery Manager
Ref No.: 18-00021
Location: Gaithersburg, Maryland
Start Date: 08/09/2018
Responsibilities
Ideal Candidate Qualities: 
-Blended skillset (some content and labeling experience)
-Experience with generics preferred
-Ability to manage artwork through artwork systems
-Must be proactive and have attention to detail
-Able to meet deadlines effectively in a fast-paced environment.
 
Position Overview: 
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. We are currently working on products for the EU and US markets.
The group is now looking for a Labeling Delivery Packaging/Artworks Manager, on a temporary basis. 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.
The role
•        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 pharmaceutical experience, preferably regulatory experience, preferably 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.
Skills and Capabilities 
•        Ability to work collaboratively
•        Building Relationships (works well across formal and informal networks)
•        Negotiation Skills (good listener; able to build a consensus)
•        Critical Information Seeking (works well across formal and informal networks)
•        Rational Persuasion (able to distil an issue to its key components and suggest solutions)
•        Interpersonal Awareness (aware of how actions affect other people)
•        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