We have a vacancy for a Label Coordinator in our Global Clinical Supplies Team. This role can be based in Ireland, Spain, France or Croatia.
Role overview
Provides support to clinical supplies operations and administrative activities in all areas of clinical supplies lifecycle of low to moderate complexity studies.
Ensures all activities are driven in compliance with company good practices and client requirements.
Participates in and supports department project teams.
May coordinate or serve as a liaison cross-functionally.
Plans and coordinates label, patient card and dosing card activities.
Ensures tasks are completed as needed according to PPD SOP requirements and/or client requirements.
Coordinates the preparation and regulatory approval of information to be included on labels, patient cards and dosing cards in clinical trials.
Reviews source documents and requests for quotes.
Assists with the development and maintenance of the Global Labeling Management tool as per SOP-CS-38 and the Translation Glossary.
Job Complexity:
Works on assignments that are semi-routine in nature but recognizes the need for occasional deviation from accepted practice.
Job Knowledge:
Applies acquired job skills and company policies and procedures to complete assigned tasks.
Supervision Received
Normally follows established procedures on routine work, requires instructions only on new assignments.
Business Relationships
Contacts are typically with individuals within own department and occasionally with contacts outside own organization. Contacts involve obtaining or providing information or data requiring some explanation or interpretation.
Qualifications:
Education and Experience:
High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification Technical positions may require a certificate Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
Intermediate English and good interpersonal skills both written and verbal
Proven understanding of the Clinical Supply process, such as manufacturing, handling, importing, shipping, exporting, auditing, labeling and packaging
Strong planning and time management skills planning analytical skills
Good analytical skills and ability to work on issues of a diverse and confidential nature
Proficient in Microsoft Office programs
Strong customer service orientation and attention to detail aligned with high standards of quality and excellence
Adaptive to changes and ability to handle fast paced situations
Ability to work in a team environment as well as work independently with moderate direct supervision
Ability to use proper channels of communications to voice concerns and suggestions
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