Manager- Healthcare GRA

Posted 26 Sep 2019

Bangalore SBS, Karnataka - India

Req Id 197937

Details

A career at our company is an ongoing journey of discovery: our around 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.


JOB DESCRIPTION

 

Key Accoutabilities

  • Ensures availability of submission-relevant documents in appropriate quality for lifecycle submissions
  • Tracks and reports progress against the Submission Content Plan to Regulatory Subteam and/or RISM Management Team for lifecycle submissions. Decides on quality checks to be performed and oversees dispatch of dossiers in liaison with Principle DSM Technician and affected Global Regulatory affairs functions
  • Supports the consistent maintenance of the dossier lifecycle for assigned product portfolio in close collaboration with submission management service provider(s)
  • Manages complex and global technical projects with limited risks and resource requirements
  • Responsible for gathering and dissemination of information about electronic e-submission capabilities from internal and external sources
  • Impacts a range of customer, operational, project or service activities within own team and other related teams that affect team performance
  • Works with substantial discretion within broad guidelines
  • Creates and maintains Regulatory Informatics and Submission Management quality documents and ensures that standards are understood and followed in RA
  • Supports evaluation and implementation of new systems supporting dossier and submission management by e.g. collecting and defining user requirements
  • Responsible for test scripts and user acceptance tests
  • Contributes to development and implementation of electronic submission tools
  • Responsible for applications support (i.e. solving business-related problems with submission management tool)
  • Responsible for communication of change requests and optimized use of existing functionality
  • May represent the company in external organizations dealing with Regulatory Informatics and Submission Management topics
  • Carries out any other tasks as required by the function to achieve its mission and objectives
  • Supports preparation and dispatch of submissions in a timely manner
  • Supports the tracking and documentation of document availability
  • Oversees parent dossiers for assigned product portfolio
  • Compiles dossiers (Uses electronic submission tools, supports hyperlinking and bookmarking of documents used in electronic submissions)
  • Publishes, produces dossiers, performs quality checks and dispatches dossiers
  • Makes proposals for an optimal use of the parent dossier setup to maximize the re-use potential of dossiers and dossier parts
  • Supports gathering and dissemination of information about electronic submission capabilities from internal and external sources
  • Supports the Dossier and Submission Manager in defining, implementing and tracking an optimal submission logistics strategy
  • Supports the Dossier Task Force Lead in defining and implementing the submission management and publishing strategy for new Marketing Authorization Application
  • Participates in design and implementation of standards (e.g. CTD. eCTD)
  • Supports gathering and dissemination of information about electronic eSubmission capabilities from internal and external sources.
  • Supports or manages small technical projects
  • Contributes to technical updates of Global Regulatory Affairs quality documents
  • Provides input to user requirements. writes test scripts and performs user acceptance test
  • Archives all published dossiers electronically. Supports the archival of relevant correspondence electronically (where applicable)
  • Carries out any other tasks as required by the function to achieve its mission and objectives

 

 

 

 

Additional Responsibilities-

  • Manages complex and global technical projects
  • Consults regulatory sub-teams on specific GRO topics
  • Networks with Global Product Teams and Regulatory Sub teams to understand risks to the successful delivery of submissions
  • Collaborates closely with the Principle DSM Technician on submission projects
  • Collaborates with Global Regulatory Affairs and other functions (e.g. Tech Ops, Research, Clinical, Drug Safety) providing submission-relevant documents
  • Act as a contact for submission management service provider(s) for advanced submission management questions, e.g. eCTD strategy, lifecycle management etc.
  • Explains difficult or sensitive information
  • Uses sound interpersonal skills to advance discussions and build consensus across the business and with external customers, suppliers or agencies, primarily regarding own technical area or discipline
  • Collaborates with IT
  • Collaborates with software vendors for maintenance, improvement and further development of the submission tool
  • May represent the company in external organizations dealing with EDMS and regulatory systems in certain cases
  • Participates in Regulatory Sub teams or any other communication flow between Global Regulatory Affairs departments and Regulatory lnformatics and Submission Management
  • Collaborates with global functions providing submission-relevant documents
  • Collaborates with submission management service provider(s) for pure publish questions
  • Collaborates with Local Regulatory Affairs functions
  • Collaborates with Corporate Business Technology
  • Collaborates with software vendors for maintenance, improvement and further development of the submission management tool

CANDIDATE’S PROFILE

 

EDUCATION

Master’s Degree in Pharma.

WORK EXPERIENCE

  • Experience 10 to 15 years and should have a experience of handling 10 direct reportees
  • Requires in-depth knowledge and experience in own discipline and beyond to supplement formal knowledge in order to apply principles and concepts to own discipline in resolving issues as they arrive
  • Thorough understanding of the Regulatory Informatics and Submission Management area, including process and technology solutions
  • 10 to 15 years’ experience in pharmaceutical industry in the areas of Regulatory lnformatics and Submission Management including process and technology solutions
  • Knowledge of document and submission management technology and electronic publishing.
  • Excellent knowledge of electronic tools (Excel, Word, Adobe Acrobat etc.

 


What we offer:  With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com

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