What are the responsibilities and job description for the Regulatory Affairs Coordinator Document Management Support position at Eurofins USA PSS Insourcing Solutions?
Job Description
Responsible for administration aspects of the Regulatory Affairs support. The team member will work with Regulatory Affairs colleagues and will support the following key areas : Product Dictionary data entry, compiling regulatory documents and facilitating document legalization and manufacturing documents (such as ISO Certificates and certificates of analysis), study risk assessment coordinator, and document maintenance within the document control system (VV / ETS or other).
Will work with the Global Diagnostics Regulatory Affairs Team and / or independently, based on the tasks, supporting both the Veterinary and Human Health Diagnostics Product inquiries (~30%).
Document Management support will include archiving of regulatory documents, review of documents in compliance with VMRD document handling requirements, interaction with internal customers to provide support (collaboration tools or document management related issues).
Responsibilities :
- Collaborate with the Global Diagnostic Strategists to ensure Product Dictionary information for Global Diagnostic products is up to date in product dictionary website
- Gather manufacturing documents and other documents needed to support registration as requested by the regulatory team.
- Maintains information systems (electronic and paper) for regulatory information
- Assist in the development of instructional guidance’s and processes, as applicable – Provide status updates on tasks as appropriate.
- Manages study risk assessments process including risk assessment intake, assignment, compilation, signatures, and final archival
- Visually identify and record pre-defined metadata values from electronic document headers and abstracts. Metadata values may be recorded into Microsoft Excel spreadsheets and / or into an electronic document management.
- Upload electronic documents and respective metadata into electronic document management systems.
- Perform simple to complex electronic library searches.
- Perform page merges / extractions using existing PDF documents to create new documents in preparation for further processing and filing.
- Support the departments document management operations.
- Adhere to the appropriate use of the publishing and document management systems, through use of working practices and QC regimens, such that regulatory compliance is preserved.
- Participate on global / local teams to complete assignments and tasks within a specific task force / project.
- Maintain a working knowledge of electronic publishing systems and tools and how these are applied.
- Proven ability to perform complex electronic library searches using advanced query techniques.
- May assist with the compilation and processing of electronic regulatory submission documents.
- Regulatory document submission assembly and publishing experience within a pharmaceutical or other highly-regulated environment is desirable.
Qualifications : Qualifications
A degree in Science, Pharmacy, Library Science or related business. Knowledge or experience of Diagnostics products and Regulatory Affairs preferred. At least two years experience working in Veterinary / Human Regulatory Affairs environment. Must be able to handle a high volume of tasks and also requires a keen eye for detail, an ability to learn new systems, and skill with resolving issues.
Additional responsibilities may include, but aren’t limited to : document review and processing, in-depth issue resolution. Substantial working knowledge and experience with electronic document management in a corporate setting, preferably where high volumes of internally-created documentation are managed.
The successful candidate will have experience working in a dynamic multicultural environment and working with colleagues based in multiple countries.
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
LI-EB1
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 USA PSS Insourcing Solutions is a M / F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
