Regulations Publisher

Plainsboro, NJ

13 days ago in Medical & Science

Job Type

Temporary/Contract

Posted

February 19,2015

Industry

Medical & Science

Salary

$25 - $25 Hourly

Reference

US_EN_1_020275_10328779

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We are currently seeking a Document Control Specialist for our client in Princeton, NJ. Please review the job description below in full, if you meet ALL qualifications, please follow the below instructions on how to complete the online application. This position has the potential to become a permanent opportunity for the right fit!!! We look forward to working with you!!

Adecco offers some excellent opportunities for employees! We offer a competitive health, dental, vision and 401K benefit plan available to you after your first pay check, pay is weekly via direct deposit.

• Med Device or Pharmaceutical industry experience is highly desired
• The ability to work under pressure is key

The temporary position is responsible for coordination, publishing, submission and archiving of regulatory submissions in both paper and electronic format, maintaining appropriate electronic and hard copy filing systems. Prepare and review Standard Operating Procedures. Maintain history files of SOP"s and other controlled documents. Process and maintain the Corporate Label Review and Approval Process.
Job Description
•Responsbile for taking a written submission and book marking it, hyperlinking and assemlby
Responsible for the quality of submissions generated and manages the elements of submissions to Regulatory Authorities.
• Ensure that logistics and needs for preparing and assembling regulatory filings are obtained in a timely manner. Organizing and maintaining company regulatory submissions documentation to assure it is accurate, up-to-date and readily available to appropriate personnel and during an audit or inspection. Maintains tracking systems for the completed regulatory submissions.
• Assist in the development of training materials and provides training to internal and external personnel on regulatory operations processes including document management and publishing systems.
• Responsible for coordination, implementation and ongoing improvement of these processes.
• Contributes to an environment that fosters collaboration, trust, regulatory excellence, creativity and initiative.
• Other duties as assigned

Requirements
• Education: Bachelor Degree in Science or Business related field
• Experience: A Minimum of 3-5 years working in a regulated industry is required; experience in managing regulatory submissions for device and/or drug, and biologic products. Must have proven ability to prepare and submit documents to FDA, such as 510(k) Premarket Notifications, Investigational New Drug (IND), or New Drug Applications (NDA). Must possess and demonstrate an excellent understanding of FDA and international regulatory requirements. The preferred candidate must have strong writing, project management and communication skills.
• General office equipment: computer, printers, copier, fax machines
• Knowledge in using ISI ToolBox, Roxio, Epson (CD label maker




Please complete the application by following these simple instructions:

1. Go to http://www.adeccousa.com/Pages/PassiveApply.aspx
2. Click on “Apply Here” in the top right corner.
3. Upload resume in word document
4. Select Office: 020275 or Somerset- 1 Executive Drive Suite 100, Somerset, NJ 08873
5. Fill out application and submit!!

Once you complete the online application please call us at 732-563-1660.

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