Lead Associate, Publisher!
Genpact
5 - 10 years
Mumbai
Posted: 9/3/2024
Job Description
Responsibilities
The Role demands for an experienced Publisher with demonstrated ability to execute responsibility in a highly regulated & process driven environment, the Person will be responsible for all the activities related to
• Publishing and performing technical validation of eCTD submissions for US 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 acknowledgement 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.
• Co-ordinate with client/stakeholders
• Project Management skills
Requirements
• Qualifications
Minimum qualifications
• B. Pham/M.Pharm/Science Graduate
• Experience and have good knowledge of eCTD submissions and Structure & Expertise with Publishing Tools like Liquent Insight Publisher, Lorenz Docubridge, Extedo eCTDManager etc.
• In depth working knowledge of ECTD/CTD/NEES/Paper types of submission, industry standard publishing systems.
• Effective time management and organizational skills
• Effectively communication
• Flexibility to adapt to a changing environment
Preferred Qualifications / Skills
Pharmacy
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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