Labeling Business Leader

Location
Bridgewater New Jersey
Posted
Sep 27, 2018
Required Education
Bachelors Degree
Position Type
Consultant

The role is to devise strategy on how we can bring AI and Translation technology onboard through convincing business and respective stakeholders

 

Analysis: Business Analysis & Requirements – they will need to solicit, lead, reiterate, drive consensus, challenge what’s needed and formally write that down in terms of business requirements and project charter and get approval Program Management– they will need to define work packages, sequence, timelines, coordinate, host meetings, etc. SDLC– need to understand end to end sdlc – business case, requirements, design, development, testing, validation, deployment, training, support & maintenance The ideal candidate would have a broad understanding of technology combined with a understand of the Regulatory Submission space to drive the implementation of a AI driven translation solution.

 

Will be interfacing with end users to understand their needs and concerns along with the technology side dealing translating business requirements / communicating with software vendors or internal IT development team

 

Submission Planning/ Dossier preparation/Translations : Knowledge in the Regulatory Submissions space

 

1.) Enterprise Submission Planning tools and their application for tracking both the core dossier and local country submissions

 

2) translations coordination at the LOC level and hand on experience with any translations technology,

 

3.) Must have experience in leading implementation of any Regulatory software such as publishing tool/ labeling software. Preferred experience across Pharma, Consumer and Medical Devices.

 

Analysis: Business Analysis & Requirements – they will need to solicit, lead, reiterate, drive consensus, challenge what’s needed and formally write that down in terms of business requirements and project charter and get approval Program Management– they will need to define work packages, sequence, timelines, coordinate, host meetings, etc. SDLC– need to understand end to end sdlc – business case, requirements, design, development, testing, validation, deployment, training, support & maintenance