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Regulatory Operations Document Management Assistant
Ref No.: 16-07210
Location: Hampton, New Jersey
Position Type:Contract
Start Date / End Date: 11/14/2016 to 03/13/2017

The Regulatory Operations Document Management Assistant provides general support and assistance within the department. This individual will primarily focus on scanning, archival and record management support.

Candidates should:

• Demonstrate a basic understanding of the rules governing development and approval of Pharmaceuticals/Medical Devices
• Provide reliable interpretations of regulations and guidance documents
• Exhibit some independent problem solving skills on routine problems
• Able to work and problem solve both independently and as part of a team
• Able to work within deadlines as imposed by internal guidelines; ability to provide metrics/progress reports on project milestones
• Able to handle multiple tasks/projects and demonstrate flexibility in managing changing priorities
• Able to read, understand, and apply regulations to company's activities
• Be detail oriented and organized
• Must be team oriented and be able to work well with others

Key responsibilities include:

• Maintains physical and electronic documents and ensures files are effectively organized
• Reviews transmitted material and accepts or rejects the material in accordance with established procedure
• Performs documentation formatting and word processing according to sponsors approved style guide and documentation standards
• Assists in the tracking, archival and retrieval of regulatory submissions following instructions from supervisor
• Responsible for the collection, scanning, filing in EDMS as appropriate


Skills:
• Familiarity with the structure of a regulatory dossier
• High attention to detail
• Excellent word processing and computer skills
• Knowledge of the regulatory submission process and 1-2 years experience in pharmaceutical area related to Regulatory Affairs/Regulatory Operations

Education:
• High School graduate, with some college preferred