Technical Associate, Publisher!

Technical Associate, Publisher!

Genpact (NYSE: G) is a global professional services and solutions firm delivering outcomes that shape the future. Our 125,000+ 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 & process-driven 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 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. Qualifications we seek in you! 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

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. Get to know us at www.genpact.com and on X, 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.