Assistant Phrase Library Administrator


Company Description

Consider joining Eurofins Lancaster Laboratories where people are the most important element in our chemistry.

Celebrating 50 years of service, Lancaster Laboratories is a leading contract lab providing testing and research services in the environmental, pharmaceutical, and biopharmaceutical sciences to clients worldwide.


Job Description

Position Summary:

Interface globally with Label Specialists (LS), Packaging Coordinators (PC), External Regulatory Affiliates (ERA) and Quality Assurance to support Clinical Supply Packaging (CSP) with on-time delivery of packaging and labelling of Clinical trial supplies.

Assist the Phrase Library Administrator (Administrator) with the creation and approval of English Master Key phrases and the routing of English Master Key phrases for country translations.

Assist the Administrator with the periodic review of the country Regulatory Label Templates used to generate Clinical labels.

Assist with the maintenance of the ‘Regulatory Rules Engine' functionality within computerized systems.

Monitor the Phrase Library Administration mailbox and with support from the Administrator provide oversight on phrase and regulatory related label queries.

Be responsible for scribing meeting minutes and collating label related metrics.

Technical Responsibilities - Phrase Library Administration

· Liaise with the Packaging Coordinator to initiate new English Master Key label phrases and subsequent phrase translations

· Liaise with the Packaging Coordinator and External Regulatory Affiliate (ERA) to amend/obsolete current approved phrases and/or translations

· In accordance with global procedures, assist with the periodic review of the country Regulatory Label Templates in partnership with the ERA

· Where applicable, generate ‘NEW' country Regulatory Label Templates using information supplied directly by the ERA and complete the template approval process

· Maintain the ERA Label Approver and Phrase Translator contact/distribution lists

· Monitor timelines for phrase translations as provided by the ERA

· Assist with producing Phrase Library administration related metrics on a monthly/quarterly basis to ensure Service Level Agreements are met

· Assist the Administrator with quality investigations in partnership with the Global Label Group Lead and Quality Assurance

· Provide oversight for the maintenance of data/documentation located in the Global Label Group SharePoint site


Qualifications

Basic Qualifications

· High School Diploma or above

· Working knowledge and understanding of the full Microsoft Suite.

Able to fully use Outlook, Office tools, and experience with SharePoint would be desirable

Ideal Candidate will possess

· Some experience within the Clinical Supply Packaging/Labelling industry beneficial but not essential

· Some experience of using label design software

· Familiar with GMP and compliant ways of working

· Awareness of global regulations pertaining to Clinical label/Clinical trial regulations

· Excellent communication skills, both written and oral

· Strong documentation skills

· Strong problem solving skills and ability to work on own initiative

· Ability to work independently and within a team environment to resolve problems, schedule and prioritize work

· Ability to work to a high degree of accuracy whilst meeting deadlines to challenging timelines

· Strong interpersonal skills to form strong working relationships with colleagues driving collaboration

· Ability to quickly learn new processes and share knowledge

· Willing to operate in a flexible manner and be able to switch priorities at short notice and support multiple tasks

· Passionate about quality and customer service


Additional Information

What we offer:



  • 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


Position is full-time, working 12 hour shifts.

Candidates currently living within a commutable distance of Bothell, Washington are encouraged to apply.

Eurofins Lancaster Laboratories Professional Scientific Services® (PSS) is a global, award-winning insourcing solution that places our people at our clients' site dedicated to running and managing laboratory services while eliminating headcount, co-employment and project-management worries.

We infuse our 55-year track record of scientific and laboratory operations expertise, as well as HR and great place to work best practices, to recruit, hire, train and manage highly qualified scientists to perform laboratory services using our client's quality systems and equipment.

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

All your information will be kept confidential according to EEO guidelines.

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

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