Open Positions

Solution Specialist Client Services
The Solution Specialist will work as part of the ACUTA Client Services team, to assist our customers with the implementation, validation and support of ACUTA solutions. This includes the authoring and maintenance of technical documentation. The candidate must provide Pacific Time zone coverage for West Coast customers. The Solution Specialist must have a strong technical background with the deployment of web applications running in IIS and experienced with Windows server operating systems and Virtual Machines. Computer networking experience is a huge plus. The Solution Specialists will be significantly client facing, possessing well-honed presentation and communication skills, in addition to subject matter expertise. Regulatory Operations and Publishing Knowledge is a plus, but not required.
Location: Bensalem, PA United States
Duties and Responsibilities Primary
  • Technical Support – Provide technical support coverage for ACUTA customers. This includes monitoring incoming customer emails, reproducing and escalating issues as needed.
  • Implementation and Validation Services – Deploy ACUTA software at the customer site, or in the ACUTA Azure cloud hosting platform. This includes performing validation services such as Installation Qualification (IQ) and Operational Qualification (OQ) services.
  • Systems Management – Manage and monitor installed systems and infrastructure under the governance of Client Services.
Secondary
  • Pre-sales support – Provide technical assistance and contribute to the overall RFP/RFI process as required. Act as the sales team's technical encyclopedia during the sale, representing the technical aspects of how the product solves specific customer problems.
  • Documentation – Contribute in the authoring and review of all ACUTA technical product documentation and validation scripts (e.g. URS, FRS, IQ, OQ, PQ, Summary Reports and Traceability Matrix).
Industry Knowledge
  • Understanding of the Life Sciences industry and in particular the drug development lifecycle process.
  • Understands various regulatory submissions and recognize the differences.
  • Understands the needs, guidelines and complexities of electronic publishing.
  • Understanding GxP Regulations such as 21-CFR Part 11 guidance and system validation requirements in the Life Sciences industry.
Qualifications
The Solution Specialist is expected to have 4 or more years of overall technical solution deployment and support experience, with a good understanding of the pharmaceutical regulatory affairs and operations activities. In addition, he/she must have 2 or more years of field experience deploying technology solutions on-site or remotely. Some of the required technical skills and abilities include a working knowledge of:
  • Relational databases (primarily Oracle and SQL Server)
  • Windows server operating systems
  • Microsoft products such as Office and cloud platforms like Azure.
  • Virtual Machines such as VM Ware, Virtual PC, Hyper-V and Azure VM’s
  • Networking infrastructures (web interfacing, client server, Azure VNets etc.)
  • IIS Web Application server environments
Junior Regulatory Associate
This position provides electronic document publishing services (templates, formatting, proof-reading, publishing, and archiving) for regulatory documents. This position also executes and maintains processes for ACUTA Customer Regulatory submissions, correspondences, and commitments.
Location: PA & MA, United States & Bengaluru, India.
Duties and Responsibilities
  • Creating Bookmarks and links as per regulatory standards.
  • Perform tasks and make word documents,pdf documents submission ready.
  • Develop skills on publishing and learning and using different software tools.
  • Participating in Solution activities and assisting in all regulatory activities.
  • Publish Regulatory submission documents to Agency, Industry and Customer defined standards (INDs, NDAs, BLAs, CTA, MAA, eCTD, NeES, etc.)
  • Execute assigned activities for eCTD life-cycle document management within the document management system and the ARIM system.
  • Execute, adhere to, and recommend improvements to Regulatory Operations work practices and guidelines.
  • Execute Regulatory submissions quality assurance processes on electronic submission documents and the validation processes for eCTD submissions as directed.
  • Required to work at onsite at a customer location when assigned.
Qualifications
  • Bachelor/Master's degree in Life sciences, Pharmacy.
  • Maters in Regulatory Affairs and equivalent is a plus.
  • 1 + years of advanced user skills using Microsoft office suite and Adobe Acrobat desktop publishing techniques for regulatory submission documents are required.
  • 1 + years in the pharmaceutical industry Regulatory Operations arena is desired.
  • 1 + years of hands on experience with an eCTD Software System is desired.
  • 1 + year of user experience within Document Management System is desired.
  • Knowledge of the industry standards for desktop publishing regulatory submission documents, including Case Report Forms, to eCTD readiness is desired.
  • Experience publishing Clinical Study Reports to ICH E3 standards for use in eCTDs is desired.
  • General knowledge of Computer System Life Cycle Management techniques is desired.
Junior Training Specialist
The Junior Training Specialist will assist the Training Specialist in creating the product training curriculum and delivery of training via live or web-based as needed to ACUTA customers, partners and employees. This includes the authoring and maintenance of all training related courseware, user manuals including authoring and maintenance of client-facing end-user documentation for print or online access. The ideal candidate will work collaboratively with cross-disciplinary teams including account managers, information systems, end users, department managers, and senior team members.
Location: Bensalem, PA United States
Duties and Responsibilities Primary
  • The ability to analyze and synthesize the product’s technical content and work with Subject Matter Experts (SMEs) to maximize training efficiency and help develop each training course.
  • Contribute to the development of the product training materials including: Training Agendas, Training Manuals, Student Lab exercises, Instructor Workflows and PowerPoint Presentations.
  • Assist in the delivery of synchronous training classes to client audiences onsite or via a virtual web-based training environment.
  • Work with clients to schedule and coordinate training classes.
  • Administer training assessments, training certificates, user evaluations and archive all training records.
  • Create, update, and maintain client training documentation including user manuals and quick reference guides, translating system functionality into user-friendly training materials for end users.
  • Maintain technical knowledge of all ACUTA software solutions, including staying up-to-date on feature updates and system enhancements.
  • Attend project meetings.
  • Act as a liaison between client services and clients from time to time.
  • Perform other related duties as required or assigned.
  • Work with team members and other departments professionally to achieve company and department goals.
Qualifications
The Junior Training Specialist must possess well-honed presentation and communication skills, delivering training in person and via the web. Life Sciences experience is a plus, as well as a background training on enterprise software.
  • Bachelor’s degree, or training/instructional design certification with 1-3 years of equivalent work experience in software training and documentation.
  • Minimum of 1-3 years of overall curriculum design and software training experience.
  • Basic knowledge of effective andrological theories and instructional design methodologies for learning are not required but preferred.
  • Basic knowledge of active training programs and blended learning theory is not required but preferred.
  • Experience in the Life Sciences industry and in particular the drug development lifecycle process and the publishing of electronic regulatory submissions.
  • Competency with Microsoft Office applications (specifically Outlook, Word, and PowerPoint) and basic knowledge of how to navigate in SharePoint.
  • Strong communication skills are required, and prior experience with classroom training and presentation skills are a plus.
  • Ability to instruct individuals and groups for several hours.
  • Ability to travel 15-25%.
  • Self-directed individual, with a willingness to contribute to continuous improvement of training methods/materials.
  • Strong analytical thinking and troubleshooting skills.
  • A high degree of attention to detail is required, and strong technical writing and grammatical skills are preferred.
  • Previous experience with eLearning authoring is a plus.
  • Synchronous classroom instruction experiences preferred but not required.
Skills
  • Strong verbal and written communication
  • Customer Service.
  • Active listening and attention to detail
  • Critical Thinking
  • Multitasking
  • Life Sciences experience is a plus

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