• Technical Design Expert - Gx Registration Management Jobs in Hyderabad,India

  • Novartis AG
  • Save Job
  • 8 - 10 Years
  • Posted : above 1 month

Job Description:

Job ID 266766BR

Position Title Technical Design Expert - Gx Registration Management

Job Description Novartis Business Services IT (NBS IT) is working to support Novartis to deliver better patient outcomes through innovative use of information and technology As technology is reshaping the healthcare industry, IT will be a differentiator for our businesses, inspiring new ideas and enabling Novartis to reimagine medicine

To continue to add even greater value for the business we need to have the right people with the right capabilities in the right location We need to be customer-oriented and focus on bringing the best services and solutions to the business both globally and locally to support our patients

NBS IT offers this extraordinary work experience with a real opportunity to develop in a highly fast-paced technology-driven environment where collaboration and innovation are at the heart of who we are and what we do

Role Purpose

The Technical Design Expert has a key role in architecture designing and technical implementation of regulatory submission / document management solutions that deliver efficiencies for our business, enable global use of the regulatory submission / document management systems, and meet defined Novartis IT Security standards

The Technical Design Expert is actively involved in creating the detailed IT solution/service design based on functional specifications, to meet quality and performance requirements and technical constraints In this Position you will be working on global strategic initiatives within GxP compliant Regulatory environment ( Sandoz regulatory affairs )

Main Accountabilities
Create the detailed process designs necessary to operate the software/service on a day-to-day basis
Ensure designs produced adhere to architectural roadmap and support the development, execution and operations of software/service
Ensure that detailed designs adhere to solution architecture design (ie high level conceptual design) and are traceable to functional as well as non-functional requirements in functional specification
Ensure the overall user experience is taken into account when designing new solutions and services
Take accountability to ensure adherence with Security and Compliance policies and procedures within Service Delivery scope

About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care Novartis has leading positions globally in each of these areas In 2016, the Group achieved net sales of USD 485 billion, while R&D throughout the Group amounted to approximately USD 90 billion Novartis Group companies employ approximately 121,000 full-time-equivalent associates Novartis products are sold in approximately 155 countries around the world For more information, please visit http//wwwnovartiscom

Minimum requirements At least 8 10 years experience in SDLC and system validation in highly regulated environment, ideally in Pharma industry experience in Regulatory domain would be a plus
Strong knowledge of Open Texts Documentum, D2, and Life Science Suite software - Knowledge on Lorenz docuBridge, eValidator and/or other Submission Mgmt tools is a plus
Expert understanding of technical design / implementation and system architecture concepts as well as IT solutions across the industry
Experience working on (global) project teams to deliver with quality, on-time, and within budget
Experience architecting and implementing business, quality, and technical requirements for GxP systems
Excellent verbal and written communication skills in English
Strong interpersonal, communication, collaboration and analytical skills with ability to interact with a diverse internal and external audience and to interpret and communicate complex information Ability to influence and exercise business judgment
Self-starter with ability to work with minimal supervision in a highly matrixed and multi-cultural environment, taking full ownership of deliverables
Education university degree equivalent to MS level in Computer or Life Sciences

Division NBS

Business Unit IT NBS

Location India

Site Hyderabad, AP

Company/Legal Entity Nov Hltcr Shared Services Ind

Functional Area Information Technology

Job Type Full Time

Employment Type Regular

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : IT Software : Software Products & Services
Role : Application Programming
Salary : As per Industry Standards
Deadline : 08th Mar 2020

Key Skills:

Company Profile:

Novartis AGarfix

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