Lead Consultant, Publishing
In this role, you will be responsible to work on deadlines, in a fairly high pressure business environment while being a good team member. You should have the ability to work well in cross-functional teams, exhibiting a combination of active listening skills and the confidence to guide decision-making for the document content strategy.
Responsibilities
The Role demands for a highly qualified professional who should have proven experience and have good knowledge of ICH guidelines and CTD Structure & Expertise with Publishing Tools like Docubridge, liquent etc.
In this role, you will be responsible for all the activities related to
Perform document level & submission level publishing, assembly and distribution activities.
Performing submission readiness checks.
Compiling SAS and other datasets and non-PDF files.
Publishing documents for eCTD, NeeS, paper, and other PDF format submissions.
Performing final technical quality review and technical validation (eCTD/NeeS)
In depth solid understanding of ECTD/ NEES types of submission, industry standard publishing systems.
Effective time management and interpersonal skills to efficiently run multiple time-sensitive assignments simultaneously
Demonstrates 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
Demonstrates the ability to independently solve trouble shoot problems that arise within job responsibilities and expectations, and takes a new perspective using existing solutions
Effectively communicates difficult issues both verbally and in writing to build alignment around a complex situation
Flexibility to adapt to a changing environment, keeping current with new and updated processes and procedures
Minimum Qualifications
Bachelor s degree in pharma / Science
Strong financial analytical skills and problem solving skills.
Effective communicate in writing and verbally to senior management.
Experience in balancing customer facing role and work assessments.
Self-starter and have analytical, prioritization skills
Ability to balance customer governance meetings
Preferred qualifications
Able to further working relationships with the team, peers and clients, scheduling flexibility required
Overall candidate should have decision-making, research and analytics approach and in numbers.
Good people and customer handling skills.
Effective communication and interpersonal skill.

Genpact (NYSE: G) is a global professional services firm focused on delivering digital transformation for our clients, putting digital and data to work to create competitive advantage. We do this by integrating lean principles, design thinking, analytics and digital technologies with our domain and ...