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Regulatory Affairs Consultant (Submission/Publishing Systems)

Expired Job

Quantum World Technologies Inc. Princeton , NJ 08540

Posted 3 months ago

Job Title: Regulatory Affairs Consultant (Submission/Publishing systems)
Duration: 6-12 Months Contract
Location: Princeton, NJ

C2C is allowed

Job Description

We are looking for pure IT role and experience. looking for candidates who can install, configure these systems
We need technical hands-on person not publisher i.e. a business person.

8-10 years of experience with Regulatory Submission/Publishing systems (Lorenz preferred, Parexel Insight Publisher, CSC eCTDXpress)
5 years of experience with Regulatory Submission Validation systems (GlobalSubmit, Lorenz, Extedo)
Experience with Validation in a Regulated Pharmaceutical environment
Knowledge on translating regulatory publishing requirements into functional requirements.
Knowledge in designing of publishing systems.
3-5 years of experience with EMC Documentum
Experience with all major health agency (FDA, EMEA, HC, Swiss etc.) and aware of all CTD standards for regional submissions.
Experience with SQL, DQL and RDMS concepts.
Extensive Exposure to health care and Health Care Domain Expertise

Anuj Kumar Singh
Quantum World Technologies Inc.
199 W Hillcrest Dr, Suite#0112, Thousand Oaks, CA 91360
Office: Ext-149
Fax :
E:

Skills:
installation, confifuration, submission, publishing, eCTDXpress, Lorenz, GlobalSubmit, Extedo, Parexel Insight Publisher, EMC Documentum, DQL, RDMS concepts
Permanent


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Regulatory Affairs Consultant (Submission/Publishing Systems)

Expired Job

Quantum World Technologies Inc.