Eurofins USA PSS Insourcing Solutions
Regulatory Affairs Veterinary Clinical Project Associate
Eurofins USA PSS Insourcing Solutions, Kalamazoo, Michigan, United States, 49006
Job Description
As a member of the Diagnostic Regulatory Team, this position prepares and facilitates approval of editor’s copies of veterinary diagnostic product labels required for USDA licensing and global marketing authorization.
Job Duties include, but are not limited to:
Liaise with project teams, commercial colleagues, manufacturing, and in-country regulatory affairs managers to ensure alignment on content and subsequently thorough review of drafts to provide accurate editor’s copies to the company artwork center.
Facilitate translation with external agency and review of translations by in country regulatory affairs managers.
Utilize checklist and Outline of Production to ensure label compliance with USDA and global regulatory expectations.
Generate new or revised editor’s copies of labels for veterinary diagnostic product instruments and consumables.
As applicable, utilize company systems for entry and tracking of regulatory activities.
Manage and communicate accurate timelines for deliverables.
Qualifications:
Bachelor's in relevant discipline
Prior product label experience.
Knowledge of SAP, Veeva Vault and Trackwise preferred
Strong verbal and written communication and organizational skills.
High level of competency using Microsoft Office suite, Microsoft Word, Excel and Adobe Acrobat.
Ability to effectively communicate in English with colleagues at all in various levels of the organization.
Attention to detail to ensure all expectations for labels are met
Flexibility and capacity to handle multiple tasks at once.
Demonstration of highly effective teamwork, passion, "can-do" attitude, and enthusiasm
Consistently models behaviors of accountability, approachability, and ownership.
Ability to work independently, while fostering good working relationships across physical distance.
Capability of supporting colleagues / teams in a multicultural, dynamic and constantly changing learning environment.
Authorization to work in the United States indefinitely without restriction or sponsorship
Additional Information
Position is full-time, Monday - Friday 8:00am - 5:00pm. Candidates currently living within a commutable distance of Kalamazoo, MI are encouraged to apply.
Excellent full time benefits including comprehensive medical coverage, dental, and vision options
Life and disability insurance
401(k) with company match
Paid vacation and holidays
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
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Job Duties include, but are not limited to:
Liaise with project teams, commercial colleagues, manufacturing, and in-country regulatory affairs managers to ensure alignment on content and subsequently thorough review of drafts to provide accurate editor’s copies to the company artwork center.
Facilitate translation with external agency and review of translations by in country regulatory affairs managers.
Utilize checklist and Outline of Production to ensure label compliance with USDA and global regulatory expectations.
Generate new or revised editor’s copies of labels for veterinary diagnostic product instruments and consumables.
As applicable, utilize company systems for entry and tracking of regulatory activities.
Manage and communicate accurate timelines for deliverables.
Qualifications:
Bachelor's in relevant discipline
Prior product label experience.
Knowledge of SAP, Veeva Vault and Trackwise preferred
Strong verbal and written communication and organizational skills.
High level of competency using Microsoft Office suite, Microsoft Word, Excel and Adobe Acrobat.
Ability to effectively communicate in English with colleagues at all in various levels of the organization.
Attention to detail to ensure all expectations for labels are met
Flexibility and capacity to handle multiple tasks at once.
Demonstration of highly effective teamwork, passion, "can-do" attitude, and enthusiasm
Consistently models behaviors of accountability, approachability, and ownership.
Ability to work independently, while fostering good working relationships across physical distance.
Capability of supporting colleagues / teams in a multicultural, dynamic and constantly changing learning environment.
Authorization to work in the United States indefinitely without restriction or sponsorship
Additional Information
Position is full-time, Monday - Friday 8:00am - 5:00pm. Candidates currently living within a commutable distance of Kalamazoo, MI are encouraged to apply.
Excellent full time benefits including comprehensive medical coverage, dental, and vision options
Life and disability insurance
401(k) with company match
Paid vacation and holidays
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
#J-18808-Ljbffr