Relsys International, Inc., the leading innovator of quality software solutions for the Pharmaceutical and Biotechnology industries, is seeking highly-motivated, hands-on, entrepreneurial leaders to build its world-class organization. If you thrive on challenges, enjoy solving diverse and complex problems, and have a passion to develop and promote products that protect lives, then consider joining the Relsys Global Team. All positions have competitive salaries with full benefits, performance-based bonuses, and profit-sharing plans. Relsys International, Inc. is an Equal Opportunity Employer. Application Consultant - Europe Project Manager - NY/NJ Metro Based Executive Assistant - Irvine, CA Business Analyst, Data and Document Management- Irvine, CA Business Analyst, Pharmacovigilance - Irvine, CA Business Analyst, Regulatory Compliance and Reporting- Irvine, CA Business Analyst, Application Distribution and Workflow- Irvine, CA Senior Software Quality Assurance Engineer - Irvine, CA Senior Customer Service Engineer - Irvine, CA Application Consultant - Irvine, CA or NY/NJ Metro Based Scope of Position Primary business/functional/application consultant on a client project, providing expertise in developing business processes, configuring the application, and implementing the Argus Safety suite of applications. Responsibilities Provides business expertise with all aspects of deployment services, which include: Provide expertise on the business of drug safety and pharmacovigilance Provide application expertise on Relsys products including Argus and related modules. This includes consulting on: Business Process (SOP) development Application configuration and functional testing (OQ/PQ) User and Administrator's Training Issue resolution Running workshops and pilots Data migration/mapping System validation, etc. Accountable for specific application deliverables such as configuration Consult on more than one implementation at one time As a business advisor to the project team, the consultant is responsible for participating and contributing toward the attainment of group and individual goals by transferring knowledge, monitoring engagement team performance, and providing timely feedback to company as well as the customer Working with the product development and other engineering teams to select the appropriate tools and procedures to support implementation Practice development (internal) projects as assigned, to grow the company Education University Degree, Business or Science MBA/MS Preferred Requirements Seven to ten years overall work experience with at least three years of consulting experience gained in a pharmaceutical environment, preferably in system validation and/or pharmacovigilance, or in drug safety departments. Must have experience delivering enterprise software implementations Highly desirable to have process mapping and design experience Experienced in current technologies and platforms including project management tools and database applications back to top Application Consultant - Europe Scope of Position Primary business application consultant on a client project, providing expertise in developing business processes, configuring the application, and implementing the Argus Safety suite of applications, including basic technology consulting.Responsibilities Provides business expertise with all aspects of deployment services, which include: Provide expertise on the business of drug safety and pharmacovigilance Provide application expertise on Relsys products including Argus and related modules. This includes consulting on: Business Process (SOP) development Application configuration and functional testing (OQ/PQ) User and Administrator's Training Issue resolution Running workshops and pilots Data migration/mapping System validation, etc. Accountable for specific application deliverables such as configuration Consult on more than one implementation at one time As a business advisor to the project team, the consultant is responsible for participating and contributing toward the attainment of group and individual goals by transferring knowledge, monitoring engagement team performance, and providing timely feedback to company as well as the customer Working with the product development and other engineering teams to select the appropriate tools and procedures to support implementation Provide limited technical expertise including application installation, infrastructure consulting, and Argus database knowledge Practice development (internal) projects as assigned, to grow the company Education University Degree, Business or Science MBA/MS Preferred Requirements Seven to ten years overall work experience with at least three years of consulting experience gained in a pharmaceutical environment, preferably in system validation and/or pharmacovigilance, or in drug safety departments. Must have experience delivering enterprise software implementations Highly desirable to have process mapping and design experience Experienced in current technologies and platforms including project management tools and database applications back to top Project Manager - NY/NJ Metro Based Scope of Position Direct the technical, business and personnel aspects of a consulting engagement and assist in sales efforts with existing and prospective clients. Apply project management techniques and individual technical and/or business knowledge to ensure that the quality of work product and project deliverables of a consulting engagement is of the highest quality to satisfy client expectations. Responsibilities Manages and assists customers with all aspects of deployment services, which include: Formulate project plan and manage the plan. Manage customer expectations and provide communication flow to/from the project. Primary responsibility for key PM activities such as status reporting, issue management, risk management, and project cost tracking. Provide services in the following areas: Conference room pilot, Product training, Configuration, Migration and data loading, Validation, Cut-over support, Issues resolution Provide high-level Drug Safety and application knowledge to projects. Based on customer needs, the Project Manager will be required to manage more than one implementation at one time As a technical and business advisor to the project team, the Project Manager is responsible for participating and contributing toward the attainment of group and individual goals by transferring knowledge, monitoring engagement team performance, and providing timely feedback to company as well as the customer Working with the product development and other engineering teams to select the appropriate tools and procedures to support implementation Practice development (internal) projects as assigned, to grow the company Additional responsibilities include: Managing team members Work assignment for team members Report to senior management on team member activities Conducting performance appraisals for team members Managing project documentation and knowledge Manage project logistics Education University Degree, Business or Technology MBA/MS Preferred Requirements Ten years overall work experience with at least five years of IT consulting experience gained in a pharmaceutical environment, preferably in system validation and/or pharmacovigilance. At least five years experience of project management in F500 environments Must have at least three years experience delivering at least ONE enterprise software category - ERP, SCM, CRM Experienced with SDLC, software development, systems architecture, and interfaces/reporting Highly desirable to have process mapping and design experience Experienced in current technologies and platforms including project management tools back to top Executive Assistant - Irvine, CA Scope of Position To assist and support the administration needs of high-level executive/management in various administrative tasks by providing business intelligence to make better business decisions. Primary Responsibilities Gather business intelligence for management to make better decisions (Resource Load, Departmental budgets, etc.) Facilitate the efficiency of production for management organizing the office environment (Directories, Contracts, Files, Binders) Organize management meetings and record meeting minutes Provide high quality and professional presentations & charters through Microsoft PowerPoint, Visio and other resources Minimum Qualifications B.S. or B.A. degree in either Business/Economics/Mass Communication MBA degree preferred At least 8 years working at the Executive level Exceptional organizational skills Excellent verbal and written communication skills Technical Requirements Advanced skills in Microsoft Word, Excel, PowerPoint, Outlook, and Visio back to top

Business Analyst, Data and Document Management - Irvine, CA

Owns the Argus Assurance and Dossier modules which are used for quality assurance of data for Argus Safety and intelligent document generation, authoring and publishing respectively. This position will design application features to support our customers’ data quality assurance and periodic report creation needs. Collaborates with other departments, supports sales and marketing efforts and communicates regularly with customers and prospects. Is the Relsys subject matter expert on regulations and elicits solutions to customer pains and problems within this area.

Key Responsibilities

• Owns the Functional Areas Data and Document Management. Uses varied skills to with a strict customer focus enhance and bring customer benefit to market in a timely fashion to support the product roadmap. Includes gathering marketplace, customer and regulatory inputs and competitive intelligence and translating this into system requirement specifications. Manages and reports on feature and technology roadmaps for upgrades/releases.
• Supports Engineering. Knowledge and expertise is provided to Engineering throughout the development lifecycle and projects.
• Supports Sales and Global Professional Services. Provides customer, market, regulatory and competitive knowledge within the functional areas allotted. Trains sales and marketing on new products and releases. Makes industry and customer presentations; prepares articles; assists with GPS projects as requested.
• Documentation. Prepares or oversees and controls portions of product documentation, software manuals, user notes, website copy and customized data sets for specific customers.
• Adjudicates and Resolves Errors. Collaborates daily or as needed with Customer Support, Engineering and Quality Assurance to adjudicate errors and resolve priority issues according to accepted decision criteria.

Experience

• Requirements gathering and definition in the pharmaceutical safety (40% weight) or software industry (60% weight) experience desired.
• Exposure to regulated environments, preferably GxP.
• Bachelor’s degree or equivalent preferred.

Skills and Attributes

• Able to discuss problems, analyze and formulate solutions equally with a range pharmaceutical scientists, non-technical users, and IS analysts and developers.
• Ability to plan projects, prioritize tasks, and manage time efficiently combined with a high level of initiative and motivation.
• Well-developed interpersonal and oral/written communication skills.
• Ability to participate effectively in a team environment
• Able to represent the interests of Relsys International at external meetings and conferences.
• Self-starter and results oriented, able to accept responsibility for the planning and design phase of projects

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Business Analyst, Pharmacovigilance - Irvine, CA

Owns the Argus Perceptive module which is used for data mining and signal detection as well as workflow management to support Good Pharmacovigilance Practices. Furthermore, the Argus Perceptive module integrates signal detection and data analysis tools from leading vendors such as SAS Institute and DrugLogic. This position will design application features to support our customers’ pharmacovigilance needs as well as interacting with tool vendors. Collaborates with other departments, supports sales and marketing efforts and communicates regularly with customers and prospects. Is the Relsys subject matter expert on regulations and elicits solutions to customer pains and problems within this area.

Key Responsibilities

• Owns the Functional Area Pharmacovigilance. Uses varied skills to with a strict customer focus enhance and bring customer benefit to market in a timely fashion to support the product roadmap. Includes gathering marketplace, customer and regulatory inputs and competitive intelligence and translating this into system requirement specifications. Manages and reports on feature and technology roadmaps for upgrades/releases.
• Supports Engineering. Knowledge and expertise is provided to Engineering throughout the development lifecycle and projects.
• Supports Sales and Global Professional Services. Provides customer, market, regulatory and competitive knowledge within the functional areas allotted. Trains sales and marketing on new products and releases. Makes industry and customer presentations; prepares articles; assists with GPS projects as requested.
• Documentation. Prepares or oversees and controls portions of product documentation, software manuals, user notes, website copy and customized data sets for specific customers.
• Adjudicates and Resolves Errors. Collaborates daily or as needed with Customer Support, Engineering and Quality Assurance to adjudicate errors and resolve priority issues according to accepted decision criteria.

Experience

• Requirements gathering and definition in the pharmaceutical safety (40% weight) or software industry (60% weight) experience desired.
• Exposure to regulated environments, preferably GxP.
• Bachelor’s degree or equivalent preferred.

Skills and Attributes

• Able to discuss problems, analyze and formulate solutions equally with a range pharmaceutical scientists, non-technical users, and IS analysts and developers.
• Ability to plan projects, prioritize tasks, and manage time efficiently combined with a high level of initiative and motivation.
• Well-developed interpersonal and oral/written communication skills.
• Ability to participate effectively in a team environment
• Able to represent the interests of Relsys International at external meetings and conferences.
• Self-starter and results oriented, able to accept responsibility for the planning and design phase of projects

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Business Analyst, Regulatory Compliance and Reporting - Irvine, CA

Responsible for analyzing pharmaceutical regulations and tracing to application functionality and proactively identifying application features and functions needed to allow our customers to be compliant. Owns the functional areas of Expedited and Periodic Reporting and designs application features based on customer requirements. Collaborates with other departments, supports sales and marketing efforts and communicates regularly with customers and prospects. Is the Relsys subject matter expert on regulations and elicits solutions to customer pains and problems within this area.

Key Responsibilities

• Owns the Functional Area Regulatory Compliance and Reporting. Uses varied skills to with a strict customer focus enhance and bring customer benefit to market in a timely fashion to support the product roadmap. Includes gathering marketplace, customer and regulatory inputs and competitive intelligence and translating this into system requirement specifications. Manages and reports on feature and technology roadmaps for upgrades/releases.
• Supports Engineering. Knowledge and expertise is provided to Engineering throughout the development lifecycle and projects.
• Supports Sales and Global Professional Services. Provides customer, market, regulatory and competitive knowledge within the functional areas allotted. Trains sales and marketing on new products and releases. Makes industry and customer presentations; prepares articles; assists with GPS projects as requested.
• Documentation. Prepares or oversees and controls portions of product documentation, software manuals, user notes, website copy and customized data sets for specific customers.
• Adjudicates and Resolves Errors. Collaborates daily or as needed with Customer Support, Engineering and Quality Assurance to adjudicate errors and resolve priority issues according to accepted decision criteria.

Experience

• Requirements gathering and definition in the pharmaceutical safety (40% weight) or software industry (60% weight) experience desired.
• Exposure to regulated environments, preferably GxP.
• Bachelor’s degree or equivalent preferred.

Skills and Attributes

• Able to discuss problems, analyze and formulate solutions equally with a range pharmaceutical scientists, non-technical users, and IS analysts and developers.
• Ability to plan projects, prioritize tasks, and manage time efficiently combined with a high level of initiative and motivation.
• Well-developed interpersonal and oral/written communication skills.
• Ability to participate effectively in a team environment
• Able to represent the interests of Relsys International at external meetings and conferences.
• Self-starter and results oriented, able to accept responsibility for the planning and design phase of projects

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Business Analyst, Application Distribution and Workflow - Irvine, CA

Owns the Argus Affiliate module, which is used for remote data capture and collaboration between global headquarters and local affiliates. This position will also own the requirements for the workflow sub system of Argus and design application features to support our customers’ business process automation needs. Collaborates with other departments, supports sales and marketing efforts and communicates regularly with customers and prospects. Is the Relsys subject matter expert on regulations and elicits solutions to customer pains and problems within this area.

Key Responsibilities

• Owns the Functional Area Application Distribution and Workflow. Uses varied skills to with a strict customer focus enhance and bring customer benefit to market in a timely fashion to support the product roadmap. Includes gathering marketplace, customer and regulatory inputs and competitive intelligence and translating this into system requirement specifications. Manages and reports on feature and technology roadmaps for upgrades/releases.
• Supports Engineering. Knowledge and expertise is provided to Engineering throughout the development lifecycle and projects.
• Supports Sales and Global Professional Services. Provides customer, market, regulatory and competitive knowledge within the functional areas allotted. Trains sales and marketing on new products and releases. Makes industry and customer presentations; prepares articles; assists with GPS projects as requested.
• Documentation. Prepares or oversees and controls portions of product documentation, software manuals, user notes, website copy and customized data sets for specific customers.
• Adjudicates and Resolves Errors. Collaborates daily or as needed with Customer Support, Engineering and Quality Assurance to adjudicate errors and resolve priority issues according to accepted decision criteria.

Experience

• Requirements gathering and definition in the pharmaceutical safety (40% weight) or software industry (60% weight) experience desired.
• Exposure to regulated environments, preferably GxP.
• Bachelor’s degree or equivalent preferred.

Skills and Attributes

• Able to discuss problems, analyze and formulate solutions equally with a range pharmaceutical scientists, non-technical users, and IS analysts and developers.
• Ability to plan projects, prioritize tasks, and manage time efficiently combined with a high level of initiative and motivation.
• Well-developed interpersonal and oral/written communication skills.
• Ability to participate effectively in a team environment
• Able to represent the interests of Relsys International at external meetings and conferences.
• Self-starter and results oriented, able to accept responsibility for the planning and design phase of projects

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Software Quality Assurance Engineer I - Irvine, CA

To perform Software Quality Assurance tasks in the phases of the Software Development Cycle (SDLC) of product development for Drug Safety business, such as requirement study, design, development, validation & release in order to assure the quality of software is world class. 
The primary role of Quality Assurance Engineer at Relsys International is to significantly improve all aspects of Quality Assurance from the overall corporate quality processes to the main and focused area of improving and adhering to software development life cycle and practices of automating all Relsys product regression testing and implementing sound leading-edge practices, methodologies, standards, and procedures throughout each phase of the Relsys Software Development Life-cycle.  This position is also responsible for the implementation, existence, and administration of requirement/enhancement and defect tracking tools that utilize “real-time” communication methodologies while ollowing “state and actions” process flows with “full” ownership accountabilities.  This position is responsible for building and implementing Release Engineering and Software Configuration Management components of the organization and fully ensuring the secure v ersion control and source code management procedures and practices

Primary Responsibilities
Key responsibility is to bring innovative software solutions to market using corporate Quality Assurance standards, processes and principles:

• Planning
• Assist in planning quality assurance projects
• Assist in preparation of software quality assurance plan for each product release
• Requirements
• Participate in requirements reviews at all development phases
• Change Management
• Participate in changes reviews at all development phases
• Assess the impact of the changes and validate implementation of changes
• Design and Development
• Review Software Design, Source Code, and Unit Testing
• Perform configuration management related tasks including software build and deploying in an independent environment.
• Testing
• Create software installation testing documents and create independent QA installation  environment
• Create, review and execute Software Test Procedures, Database back-up and recovery procedure, covering functional, negative, boundary testing and preferably using automated test tools
• Creating Quality Assurance Documentation at each phase of quality assurance
• Assist in preparing Validation Report and participate in product release process
• Perform all tasks necessary to produce quality software product and follow Corporate Software Development Life Cycle.
• Assist in Alpha and beta testing with customers
• Defect Tracking
• Handle effectively defect tracking and bug management systems
• Provide directions to team members to find and report problems effectively.
• Design/ generate defect tracking reports as required by management
• Coordinate with Development team in resolving bugs.
• Process
• Adhere to the Quality System policy, procedures
• Assist in maintenance of the Quality System
• Assist in Conducting customer audits and follow-up activities
• Assist in maintaining Quality Systems records
• Assist in maintaining CAPA records

Minimum Requirements

• Strong understanding of all aspects of Software Development Life Cycle process
• Experience in Software Quality Assurance both black box and white box level
• Minimum 4 years of Software Quality Assurance experience, preferably in Medical or Pharmaceutical Industry and automated testing experience 
• Strong verbal and written communication skills
• Ability to work with cross functional departments including Customer Support and Global Professional Services
• Inter personal skills

Software Requirements

• Hands on experience with modern development languages like C++, ASP. NET etc
• Familiar with latest version of Oracle, sqlplus and Data Base administration
• Windows and related operating systems
• Experience with Microsoft, Lotus Notes e-mail systems, server and client environments
• Experience with Microsoft office tools (Word, Excel, Access, PowerPoint, Outlook.

Educational Requirements

• Bachelors Degree in Computer Science or equivalent
• Quality Assurance certification like SQA, CISA etc.

Physical

• Hearing and vision within normal ranges.
• Able to sit and stand for long periods at a time.
• Able to operate equipment and computer keyboards.

Travel Requirements

• Occasional travel to customer site for testing

Language Requirements

• Speak, read, write English
• Knowledge of European languages like German, Spanish or French will be plus
• Knowledge of Japanese will be plus

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Senior Customer Service Engineer - Irvine, CA

Provide Level 2 customer support assistance to Relsys customer base.  Level 2 support is defined as: managing and resolving issues escalated from Level 1 support.  Level 2 issues are of higher complexity and/or political sensitivity.  Provide client management skills and detailed analysis efforts to bring critical issues to resolution and provide departmental solutions.

Essential duties / responsibilities
Manage and resolve Level 2 support issues without further referral.
Interface with Relsys Software Development, Database and QA departments for resolution assistance.
Identify and escalate unresolved issues to management for impact assessment and planning.
Author and test workarounds for key issues until permanent solutions have been made in product design.
Author new Software Bulletins
Author new Knowledgebase articles
Author new FAQ content
Author new Support Portal/Website Content
Review and provide content for new product Requirements and Documentation
Plan and execute Beta and/or Customer Acceptance testing activity on new releases.
Conduct training and mentoring of departmental staff
Assist with QA department for new product release activities as needed.
Assist with GPS department for new deployment activities as needed.
Conduct meetings/presentations on behalf of department/company as needed.

Minimum Requirements
BS in Computer Science or equivalent experience.  5 years experience providing customer support for complex software products, including business applications, operating systems and networking.
Excellent written communication skills.

Software Requirements:
Extensive knowledge of SQL for troubleshooting and reporting
Extensive knowledge of ORACLE and related RDBMS systems installation and administration
Extensive knowledge of Windows operating systems usage and administration
Experience with Windows networking, TCP/IP, LAN and WAN environments
Experience with Microsoft, Lotus Notes e-mail systems, server and client environments
Experience with Microsoft office tools (Word, Excel, Access, PowerPoint, Outlook)

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