Associate - Regulatory Affairs
- Genpact India
- 1 to 2 Yrs
- Mumbai
- 5 years ago
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Job Description
*With a startup spirit and 90,000+ curious and courageous minds, we have the expertise to go deep with the world s biggest brands and we have fun doing it. Now, we re calling all you rule-breakers and risk-takers who see the world differently and are bold enough to reinvent it.
Transformation happens here. Come, be a part of our exciting journey
Are you the one we are looking for
Inviting applications for the role of Technical/ Lead Associate, Regulatory Affairs for Veeva vault promotional material compilation and Publishing
In this role, you will be responsible for the compilation and review of promotional materials in the Veeva vault.
Responsibilities
Sending compiled promotional material binder in workflow
Perform document level & submission level publishing, assembly, and distribution activities.
Performing submission readiness checks.
Hands-on Veeva vault/DMS -4M Promo mats.
Effective time management and organizational skills to efficiently manage 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 troubleshoot 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
Qualifications we seek in you
Minimum Qualifications
B. Pham/Science Graduate
Good knowledge of ICH guidelines,
Know electronic document management systems e.g., Veeva vault /DMS system (workflow, creation, and approval of task) and basic knowledge on CTD/eCTD Structure & Publishing tool hands-on.
Strong knowledge of MS Office
Preferred Qualifications
A candidate who has awareness of promotional material and Ad promo submissions/OPDP and APLB submissions will be preferred.
Enthusiasm & confidence
Adhere to our principles and values.
Time Management skills.
Pharmacy
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.
,Employement Category:
Employement Type: Full timeIndustry: IT - SoftwareRole Category: Customer Service (International)Functional Area: Not ApplicableRole/Responsibilies: Associate - Regulatory AffairsContact Details:
Company: Genpact IndiaLocation(s): Mumbai
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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 ...
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