Genpact Hiring Sr. Associate - Regulatory Affair Bachelor’s degree in pharma / Science Apply Now
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, problem solving skills
Ability to balance customer governance meetings
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