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Admin Assistant IV

FDA
Regulatory Documents
Archiving
Documentum
SOPS
Liaison
Best Practices
Problem Solving
Clerical Support
Filing
Clerical
Administrative Support
Admin Assistant
Description:

Summary:

  • Provides general administrative support to one or more managers.   Responsibilities include: Exercises discretion in handling of confidential material and information. Assists in special projects as assigned. Responsible for organization and maintenance of department filing system including potentially confidential data. May provide clerical support as necessary, including filing, etc. Completes other duties as requested.  
  • Act as the BIRDS LBAC for the group, act as first point of contact to support training and business issues for problem solving for the BIRDS (BI Regulatory Documents System) system.  Inform the group of new developments in BIRDS, current updates and relevant information.  Work closely with the DRA Manager of the EU Regional Archiving Center to discuss and develop workarounds and best practices for the archiving process.  Communicate with other Key Users and LBACs to exchange pertinent information as the new BIRDS system roles out and evolves into the Human Pharma community.  Elevate unsolvable problems to the next business level GBAs (Global Business Administrator) and the Business Support Team as necessary.
  • Documentum (IDEA for SUB) Key User
  • Provide detailed guidance for authors too successfully archive Non-Clinical & Technical reports through a series of highly regulated stages required by DRA & the FDA.  Coordinate this process with authors & the DRA Group to move the reports through the various stages & final signing & archiving.  Act as liaison with DRA, IDEA for SUB Americas & Germany, to assist users with new procedures & available training.  Act as liaison for new Boehringer Ingelheim Regulatory Documents for Submissions (BIRDS) system that is currently replacing IDEA for Sub.

Experience:

  • 4 to 5+ years of Technical Writing Experience REQUIRED
  • Experience in the Pharmaceutical industry REQUIRED
  • Minimum of a Bachelor's degree
  • Detailed Oriented
  • Clear understanding of SOPs and the importance of working compliantly
  • Attending key user meetings to stay informed in system upgrades.
  • Anticipate changes and make corrections as per standard operating procedures.
  • Ability to manage up
  • Ability to ask questions
  • Ability to collaborate and work well with others in the US and globally
  • Agility and patience is very important
  • Ability to meet deadlines
  • Learn and Suggest new and better ways of working
  • Proficient in Microsoft Word
  • Make efforts to learn and understand the BI Styles for grammar and document accuracy for regulatory submissions

Hours and Location:

  • Ability to work with employees in a global shifted time zone  (CET Germany)
  • Flexible working hours between 20 - 30 hours/ per week
  • Preferred to come on site 1 - 2 times per month

This is the pay range that Magnit reasonably expects to pay someone for this position is $26.00/hour - $35.00/hour

Benefits: Medical, Dental, Vision, 401K (provided minimum eligibility hours are met).

QUALIFICATION/ LICENSURE :
  • Work Authorization : US Citizen
  • Preferred years of experience : 1+ Years
  • Travel Required : No travel required
  • Shift timings: Not specified
Job Location Ridgefield, Connecticut
Pay USD 26.00 - USD 35.00 Per Hour
Contract Duration 51 week(s)