Genpact BPharma & MPharma Associate Job, Apply Online Now!
With a startup spirit and 115,000+ curious and courageous minds, we have the expertise to go deep with the world’s biggest brands—and we have fun doing it. We dream in digital, dare in reality, and reinvent the ways companies work to make an impact far bigger than just our bottom line. We’re harnessing the power of technology and humanity to create meaningful transformation that moves us forward in our pursuit of a world that works better for people. Now, we’re calling upon the thinkers and doers, those with a natural curiosity and a hunger to keep learning, keep growing. People who thrive on fearlessly experimenting, seizing opportunities, and pushing boundaries to turn our vision into reality. And as you help us create a better world, we will help you build your own intellectual firepower.
Welcome to the relentless pursuit of better.
The Role demands an experienced Publisher with demonstrated ability to execute responsibility in a highly regulated & process-driven environment.
- 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!
- 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.
For more information, visit www.genpact.com. 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.
Primary Location: India-Mumbai
Education Level: Bachelor’s / Graduation / Equivalent
Job Posting: Oct 20, 2023, 12:41:54 AM
Unposting: Date Ongoing
Master Skills: List Operations
Job Category: Full Time
Keywords: Genpact, BPharma, MPharma, Associate, Job, Apply Online, Publisher, LATAM, Canadian Submissions, Technical Validation, Quality Review, Post-submission Processing, ICH Guidelines, CTD Structure, Liquent, Docubridge, Pharmacy Regulatory Affairs, Equal Opportunity Employer. Genpact BPharma & MPharma Associate Job, Apply Online Now! Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.