Job Description

1-year initial contract

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 internal RDS (Regulatory Documents System).
• Inform the group of new developments in Department, 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 admins to exchange pertinent information as the new RDS 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 Regulatory Documents for Submissions (RDS) system that is currently replacing IDEA for Sub.

Skills:

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

Education:

• HS Diploma.

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