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Document Coordinator

  • Full Time, onsite
  • Rootstaff: Executive Search Firm
  • Ridgefield, United States of America
Salary undisclosed

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Title: Admin Assistant /Department Document Coordinator

Duration: 12 months (2-3 Days Onsite)

Location: Ridgefield, CT 06877

Job Description:

Duties:

  • 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 first point of contact to support training and business issues for problem solving for the Regulatory Documents System.
  • Inform the group of new developments in system, 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 to exchange pertinent information as the new 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 company’s Regulatory Documents for Submissions system that is currently replacing IDEA for Sub.

Skills:

  • Previous admin experience necessary.
  • Steady work history needed.

Education

  • Associates Degree

Title: Admin Assistant /Department Document Coordinator

Duration: 12 months (2-3 Days Onsite)

Location: Ridgefield, CT 06877

Job Description:

Duties:

  • 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 first point of contact to support training and business issues for problem solving for the Regulatory Documents System.
  • Inform the group of new developments in system, 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 to exchange pertinent information as the new 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 company’s Regulatory Documents for Submissions system that is currently replacing IDEA for Sub.

Skills:

  • Previous admin experience necessary.
  • Steady work history needed.

Education

  • Associates Degree