Technical Associate: Publisher
Genpact
0 - 3 years
Bengaluru
Posted: 20/11/2024
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.
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