Senior Associate, Global Regulatory Systems & Process Management copy (19-00207) – NJ – Woodcliff Lake

Senior Associate, Global Regulatory Systems & Process Management
Main duties/responsibilities:
The overall responsibilities will include but will not be limited to the following activities quality, best practice to developing/updating these documents:
• Business Process Maps
• User Requirements document
• Business Scenarios and Use Cases
• User Acceptance Test Scripts
• Configuration and user requirements alignment
• Data standards, user requirements and process alignment
• Process Development and Design
• 2nd Line System Support
• Developing and Implementing Support for Systems
SOP & GUIDANCE DOCUMENTATION (US, EU, Growth Markets, JP & Asia):
Summary of activities:
1. Identify and evaluate existing Regulatory SOPs/SWP
2. Identify New Regulatory SOPs/SWP
3. Identify and evaluate existing non-Regulatory SOPs/SWP
4. Revise SOPs that need revision
5. Develop new SOPs

TRAINING (US, EU, Growth Markets, JP & Asia):
Summary of activities:
1. Develop Job Aids
2. Develop User Training Materials

Competencies and other distinguishing features:
• Organization
o The candidate should be organized and be able to effectively manage multiple tasks across a day. The candidate should be able to evaluate current processes and look to continuously improve the resource and time taken for day to day tasks.
• Communication
o Communication skills will be required to build relationships globally across multiple departments to effectively plan strategies.
• Technical Knowledge
o The candidate will be required to have a technical understanding of multiple systems and should be able to easily adapt to new processes and systems. Knowledge of Document Management Systems, the Microsoft Office suite, Sharepoint and Publishing tools is required.

Education and experience required:
Qualifications required:
• College or University degree in computer sciences required

Required experience:
• The selected candidate will develop training materials for implementation of the Regulatory Tracking System. Candidates must have SOP experience and some experience in the creation of training manuals.
• 3-4 year’s experience with Systems, in particular in relation to Regulatory tracking system.
• 2-3 year’s experience in providing business support to Regulatory Information Systems
• Previous experience in pharmaceutical industry is required
• Experience of mapping User Requirements to Functional Specifications especially in respect of process management an advantage.
• Knowledge of Regulatory and Submissions processes for EU, US and Emerging Markets regions.

Skills and aptitude required:
• Strong verbal, written and interpersonal communication skills, especially relationship management, with ability to give/receive feedback and build consensus.
• Experience in handling multiple tasks
• Knowledge of MS Office (Visio, Word, Excel, PowerPoint, Project), Adobe acrobat as well as being familiar with the use of multiple system applications
• Experience of working well under pressure.
• Empathic listener and persuasive speaker.
• High level of organization and time-management.
• Pro-active and enthusiastic.
• Business Model Analysis
• Process Design
• Self-Motivation
Source: Job Diva – Job Listing

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