Technical Associate - Publisher
Technical Associate - Publisher
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Job Description
Genpact (NYSE: G) is a global professional services and solutions firm delivering outcomes that shape the future. Our 125000 people across 30 countries are driven by our innate curiosity entrepreneurial agility and desire to create lasting value for clients. Powered by our purpose the relentless pursuit of a world that works better for people we serve and transform leading enterprises including the Fortune Global 500 with our deep business and industry knowledge digital operations services and expertise in data technology and AI.
Inviting applications for the role of Technical Associate Publisher!
The Role demands an experienced Publisher with demonstrated ability to execute responsibility in a highly regulated & processdriven environment.
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 postsubmission 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 submissionsrelated correspondence from health authorities such as uploading documentation commitments and metadata.
Qualifications we seek in you!
Minimum qualifications
B. Pham/ 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
Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race color religion or belief sex age national origin citizenship status marital status military/veteran status genetic information sexual orientation gender identity physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values diversity and inclusion respect and integrity customer focus and innovation. For more information visit . Follow us on Twitter Facebook LinkedIn and YouTube.
Furthermore please do note that Genpact does not charge fees to process job applications and applicants are not required to pay to participate in our hiring process in any other way. Examples of such scams include purchasing a starter kit paying to apply or purchasing equipment or training.
Required Experience:
IC
Employment Type
Full-Time
