Thursday, 29 October 2015

Officer / Executive - Regulatory Affairs ( API )-Sun Pharmaceutical Industries Ltd


 
Job Description
1. Preparation & Compilation of DMF for emerging markets (countries in region of CIS/Asia, Middle east/N. Africa/S.Africa & LATAM) in coordination with plant regulatory affairs.

2.Review and compilation of all the documents received from plant, R&D and other departments as per regulatory requirement

3.Preparation of anticipated queries based on compilation and current query trend.

4. Review and response to the deficiencies received from regulatory authorities/Customers.


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Opening for Rave Programmer Candidates (2-6 yrs) Quintiles 2 - 6 yrs Bengaluru/Bangalore

Quintiles Careers

Dear Candidates,

Looking for experienced candidates in Rave Programming with 2 to 6 years of experience.

RESPONSIBILITIES :-
Development of eCRF to meet the needs of the customer and the clinical trial utilizing protocol and specifications provided at the pre-design meeting. Understand Quintiles EDC processes and the requirements on the design for reporting and study management.
Interprets the study protocol.
Advise and provide justification for design decisions to Principal Programmer and at multiple Design Meetings.
Responsible for optimal design reducing the number of edit checks required, ensuring good system performance, and the utilization of global/client specific libraries to ensure consistency and efficiency.
Facilitates the Internal Edit Check Specification Review Meeting and leads the discussions regarding the Edit Specifications document.
Requires good communication skills and this role will work closely with the Study DTL, Validation team lead (VTL) and Principal Programmer.
Requires a technically logical thinker to resolve questions and issues with the Principal Programmer, DTL and VTL. This role will need to have a good knowledge of forms design, data flow, and the impact of design on the system.
Presentation and negotiation skills with internal and external customers.
Communicates any project risks to the DTL, including the potential for missing a timeline in the Data Management Project Plan
Ensures the completion and documentation of all project-specific training, as well as staying current with required SOP reading
Reviews build timelines and provide inputs.
Reviews budget for own projects, identify out of scope activities if any and inform relevant parties.
Take part in post production change requests.
Understand and implement new tools and technologies of the EDC vendor (preferably Medidata).

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Urgently Required- Pharmacist - Fresher most Welcome- Bengaluru/Bangalore , Mumbai , Pune

2,75,000 - 7,50,000 P.A. + TA , DA +HRA + Conveyance

Completes pharmacy operational requirements by organizing and directing technicians' work flow; verifying their preparation and labeling of pharmaceuticals; verifying order entries, charges, and inspections.  


We are urgently hiring the Male & Female Fresher candidate .Immediately Send your resume to our company email address - career@accentureconsultancy.com

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