Genpact – Regulatory Affairs Associate job openings in mumbai
Genpact – Regulatory Affairs Associate job openings in Mumbai
Genpact jobs;
Genpact Inviting applications for the role of a Technical/ Lead Associate, Regulatory Affairs for Veeva vault promotional material compilation and Publishing.
You should have minimum experience and have good knowledge of ICH guidelines, Have knowledge of electronic document management systems e.g., veeva vault /DMS system (workflow, creation, and approval of task), and basic knowledge of CTD/eCTD Structure & Publishing tool hands on.
Strong knowledge of MS Office
A candidate who has awareness of promotional material and Ad promo submissions/OPDP and APLB submissions will be preferred.
Responsibilities
In this role, you will be responsible for all the activities related to –
- Compilation and review of promotional materials in the Veeva vault.
- Sending compiled promotional material binder in workflow
- Perform document-level & submission-level publishing, assembly, and distribution activities.
- Performing submission readiness checks.
- Perform QC and accept tasks in 4 PromoMats and Created RFP in Veeva RIM.
- Responsible for updation of binder as per client request. Addition or deletion of PI/Material in Binder.
- Upon receiving confirmation from the Publishing team close the submission and completed the task
Requirements
- 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
Key Attributes
- Enthusiasm & Confidence
- Adhere to our principles and values.
- Time Management skills.
Qualifications
Minimum qualifications; B. Pham/Science Graduate
Preferred Qualifications / Skills; Pharmacy
Location; Mumbai
Shift; Night shift (7.00 pm-3.30am-IST)
Genpact – Regulatory Affairs Associate job openings in Mumbai APPLY HERE
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
