WuXi AppTec

Data Entry / Admin Assistant

Job Locations US-MN-St. Paul
Job ID
2021-8819

Overview

Who is WuXi AppTec?

WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries worldwide to advance discoveries and deliver groundbreaking treatments to patients. Our St. Paul, Minnesota site is a rapidly growing global leader in the medical device (ranging from simple tongue depressors and adhesive bandages to complex programmable pacemakers) and combination product testing industries, focusing on nonclinical testing that includes biocompatibility, safety toxicology, and analytical chemistry.  Our teams support some of the most innovative medical devices and combination products created by leading medical device manufacturers both locally and globally. Our Test Facility plays a vital role in understanding the unique interface between biomedical engineering and the biology of living things.    As an innovative-driven, customer-focused organization, WuXi AppTec’s open-access platform enables global collaboration from over 30 countries to improve the health and/or treatment of patients in need, and to realize WuXi AppTec’s vision that “every drug can be made and every disease can be treated.”  For more information please go to http://us.wuxiapptec.com/.

 

WuXi AppTec Offers:

Medical, Dental, and Eye care Coverage - Health Savings Account + Employer Contribution - Flexible Spending Account - 401(k) Savings Plan + Employer Match - Employer Paid Basic Term Life and AD&D Coverage

Employer Paid Long Term Disability Insurance - Short Term Available with Employer Contribution

Generous Personal Time Off Plan (PTO) + 10 Holidays Per Year

 

Department Description: 

The Study Operations department is the center point of control for all studies conducted within the facility. Study operations in responsible for development and execution to the study protocol, client communication about individual study information and clarification, and reporting of final assay results. Clients may request an individual test for an individual medical device, but often requests a panel of tests to support FDA submission depending on medical device use. Tasks executed within the department can be placed into the following three categories in most cases.

  • Front end work tasks involving a study would be review of study information, initiation of the study, and client communication involving clarifications such as test article preparation instructions. Review of study information and request for clarification are completed at a panel level when available and appropriate.
  • On test work tasks involving a study would be providing instruction and support to laboratory staff as necessary, troubleshooting and client communication of unexpected or unusual observations, and leading or being involved in investigations observed during the study and study impact such as deviations or laboratory investigations.
  • Back end work tasks involving a study would be complete review of study data, determination of study validity and results, drafting and finalization final report, and engaging with Quality Assurance during report review process as required.

 

The Administrative role will support execution and completion tasks in a variety of ways. 

Job Summary: 

The Data Entry/Admin Assistant provides the administrative support to assist Study Specialists and Study Directors in their completion of nonclinical studies that meet WuXi AppTec’s Clients/Sponsors expectations.

Responsibilities

  • Provide administrative support to Study Directors including filing, file creation, documentation and processing of forms and other various forms of paperwork
  • Opportunities to learn and assist / coordinate the report process from data collection to release of the final draft report, including sending final reports to clients.
  • May support IACUC submissions, protocol revisions, creating and organizing study files.
  • Interest in working in a regulated environment. This includes developing a working knowledge of Good Laboratory, Documentation and Manufacturing Practices.
  • Scan paper documents into electronic format and send to off-site staff
  • Copy / paste / enter data from Word to Excel programs
  • Work in multiple documents at once, including spreadsheets and Word documents
  • Ability to work in a team environment and independently as required
  • Completes tasks / work, requiring minimal instructions, only requiring assistance or detailed instructions or on new assignments.
  • Review projects to ensure paperwork is complete and accurate.
  • Assist with gathering proper documentation / copies and corrections
  • Time management of multiple items and priorities while ensuring accuracy, and completeness of tasks.
  • Other duties as assigned and may also be required to assist in other departments.
  • Learn and Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.

 

Qualifications

Experience / Education:    

  • Minimum of a High School Diploma or equivalent. Some post high school coursework in a related field is beneficial.
  • Minimum of 1 year of direct experience providing administrative support including demonstrated experience with Microsoft Office and/or other administrative applications.

Knowledge / Skills / Abilities:

  • Attention to detail critical to success
  • Ability to balance multiple responsibilities and requests from multiple stakeholders
  • Skilled in scanning paper documents into electronic format
  • Proficient Verbal & Written communication skills.
  • Able to read, write and understand English.
  • Proficient in Microsoft Office (Excel, Word, Outlook) and template building.
  • Providing administrative support to a scientific, technical or engineering function is beneficial.
  • Past experience working in a regulated industry where outputs must meet regulatory standards is a plus.

 

Physical Requirements:

  • Must be able to work in an office environment with variable noise levels
  • Clarity of Vision
  • Must be able to perform activities with repetitive motions
  • Inside working conditions

 

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.  Employees holding this position will be required to perform any other job-related duties as requested by Management.

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