Technical Associate: Publisher

Genpact

0 - 3 years

Bengaluru

Posted: 20/11/2024

Getting a referral is 5x more effective than applying directly

Job Description

Responsibilities

Publishing and performing technical validation (eCTD/CTD/NeeS/Paper) for the LATAM and Canadian Submissions.
Performing final technical quality review.
Dispatching submission to the relevant authority ((eCTD/CTD/NeeS/Paper) or affiliate so that affiliate can dispatch to authority;
Performing post-submission processing activities such as receiving acknowledgment from authority of submission receipt; capturing and the electronic receipt and metadata in RIM; communicating submission receipt to key stakeholders;
Capturing submissions-related correspondence from health authorities, such as uploading documentation, commitments, and metadata.

Minimum Qualifications

B. Pham/M.Pharm/Science Graduate
In depth working knowledge of ECTD types of submission, industry standard publishing systems.
Effective time management and organizational skills
Effectively communication
Flexibility to adapt to a changing environment
Good knowledge of ICH guidelines and CTD Structure & Expertise with Publishing Tools like Liquent, Docubridge, etc.

Preferred Qualifications
Experience in Pharmacy Regulatory Affairs

About Company

Genpact is a global professional services firm delivering digital transformation by putting digital and data to work to create competitive advantage.