Regulatory Affairs Coordinator Document Management Support
Regulatory Affairs Coordinator Document Management Support
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Salary Not Disclosed
1 Vacancy
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 guidances 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 predefined 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 highlyregulated environment is desirable.
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 arent limited to: document review and processing indepth issue resolution. Substantial working knowledge and experience with electronic document management in a corporate setting preferably where high volumes of internallycreated documentation are managed.
Strong Microsoft Word Excel SharePoint site use and skills
Strong Adobe Acrobat skills and experience in PDF rendering bookmarking pagination page merging and extraction
Strong attention to detail; high accuracy rate with respect to assigned tasks.
Excellent time management and multitasking abilities.
Excellent written and verbal communication skills and listening skills.
Ability to spend prolonged periods of time working with computer systems.
The successful candidate will have experience working in a dynamic multicultural environment and working with colleagues based in multiple countries.
Additional Information :
Position is fulltime 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
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Eurofins Lancaster Laboratories Professional Scientific Services (PSS) is a global awardwinning insourcing solution that places our people at our clients site dedicated to running and managing laboratory services while eliminating headcount coemployment and projectmanagement worries.
We infuse our 55year 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 clients quality systems and equipment.
Eurofins USA PSS Insourcing Solutions is a M/F Disabled and Veteran Equal Employment Opportunity and Affirmative Action employer.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
