• Job Description

  Req#: LIF020722

  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 process developer, Regulatory Affairs for Translation management in Spanish language and Artwork review of all pharmaceutical products in LATAM market
  In this role, you would be responsible for preparation Day to Day business operation reports for Management team and Clients. This role will include supporting, coordinating, and delivering daily, weekly, and monthly reports accurately to management team and Clients. This would also include preparation and delivery of ADHOC reports, as requested to meet business needs. The candidate will work with various internal and external partners throughout the organization at all levels. You are encouraged to build databases, develop reports and ensure accurate and timely delivery of customer communication and reports. We service multiple clients and to ensure smooth business delivery the reliance on data is huge.
  Responsibilities
  • Translation Management to Spanish:
  o Translation management activities for LATAM countries
  o Coordination of dossier translation
  o Coordination of translation for maintenance events, renewals, Chemistry Manufacturing & Controls (CMC), Company Core Data Sheet (CCDS)
  o Quality check and validation of received documentation and translated documents
  o Proofreading coordination with subject matter experts such as clinical documents with the medical team of Bayer

  • Artwork Review (updates that affect product’s label)

  o Perform artwork review about updates available, which affect labels
  o Artwork review using Bayer text verification tool (TVT) software (LATAM pharmaceutical portfolio)
  o Implementation of changes with compliance with internal procedures and local regulation
  o Precise track of changes and proactive communication with involved functions in artwork review
  o
  Qualifications
  Minimum qualifications/skills
  • Knowledge of LATAM regulation and well adheres to the Spanish language
  • Should be advanced level in the English language
  • Effective time management and organizational skills to efficiently manage multiple time-sensitive assignments simultaneously
  • Demonstrate a deep understanding of the business value of quality and compliance, and the implications and risks of non-compliance. Adjusts behaviors to drive high-quality deliverables
  • Demonstrate the ability to independently solve troubleshoot problems that arise within job responsibilities and expectations, and take a new perspective using existing solutions
  • Effectively communicates difficult issues both verbally and in writing to build alignment around a complex situation and process
  • Flexibility to adapt to a changing environment, keeping current with new and updated processes and procedures

  Preferred Qualifications / Skills
  • Enthusiasm & confidence
  • Adhere to our principles and values
  • Time Management skills
  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 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.

• About the company

  Genpact is an American professional services firm headquartered in New York City, New York.

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