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Regulatory Submission - Technical Consultant
Ref No.: 18-00438
Location: Rahway, New Jersey
Position Type:Contract
Start Date: 08/16/2018
Role: Regulatory Submission Consultant
Interview Mode: Skype

Duration: 6 Months

Mandatory Skills: Experience in Publishing Tools – Lorenz, Insight Publisher, eCTDXpress ( CSC)

We are looking for Techno- Functional candidate, who can do configuration, implemetation of publishing tools like Lorenz, Insight Publisher, eCTDxpress.

- Experience in 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.