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Document Specialist

Newark Metro Area, NJ

Posted: 08/16/2019 Job Type: Scientific Job Number: JN -082019-25450

Responsibilities include:

1. Electronically manipulate internally and externally authored scientific reports, using Adobe Acrobat and ISI Toolbox, to meet FDA electronic submission requirements.

2. Provide document and word processing support in the preparation of nonclinical submission documents including but not limited to INDs, NDAs, CTD, IBs, and CTAs for submission to health authorities.

3. Attend Department Group Meetings as needed to be informed of upcoming needs for nonclinical documentation.

4. Communicate changes in reports to authors, including CRO personnel in an efficient and effective manner.

5. Track reports through review cycle and maintain internal report tracking system.

6. Support Nonclinical Development personnel as needed for report management.

7. Ensure all documents are maintained according to departmental SOP.

8. Assist with departmental training program coordinating as required.

9. Other duties related to the above within company, as assigned.


Skills/Knowledge Required:

Pharmaceutical/biotech industry experience (2-5 years) required; familiarity with drug regulatory submissions highly preferred.

Prior nonclinical experience preferred; documentation QC review experience a plus.

Documentum or eSubmission/Livelink experience preferred; electronic submission experience a plus.

Strong PC experience:

a. Experience working in Adobe Acrobat and ISI Toolbox is required.

b. Microsoft Office Suite experience required including Microsoft Word, Excel, and Outlook.

Must be flexible and adaptable to changing project priorities and work assignments.

Must have strong interpersonal skills, be a team player, and be willing to work in an environment where individual initiative and accountability are required.

Careful attention to detail and quality are essential.

Excellent technical scientific writing and verbal communication skills required.

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