Open Positions

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.
  • 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.
SharePoint Developer (Multiple Positions)
We are looking for an experienced SharePoint Developer The successful applicant will form part of a team responsible for the development and maintenance of an industry specific solution using SharePoint. This will involve all phases of the design, development and maintenance of enterprise solutions. The role will include developing in C# and .NET and working with SharePoint 2016 and Office 365 and other technologies. In this position you will be joining the development team to create solutions in a timely manner.
Location: Bengaluru, India
Duties and Responsibilities
  • Investigating, analyzing and documenting requirements.
  • Designing, developing and maintaining key software components.
  • Implementing SharePoint based workflows.
  • Designing, developing and managing site content and capabilities.
  • Testing all software developments and resolving any issues.
  • Working with project managers to provide accurate development estimates.
Systems Administrator (Only Apply if Immediately Available)
We are looking for an experienced IT Systems Administrator who has first hand experience working in a fastpaced environment. Candidate needs to be well rounded with technology and customer service. ONLY APPLY IF AVAILABLE IMMEDIATELY.
Location: Bengaluru, India
Duties and Responsibilities
  • Desktop and Laptop configuration, deployment and hardware & application related troubleshooting.
  • Administrating On-premises Windows-Servers (File servers, DC, IIS).
  • Hands on experience on Active Directory - Security Permissions, User Management, Basic knowledge of Group Policy.
  • Basic knowledge of configuring Hyper-V VM’s/VMWare.
  • Maintenance of Desktops, Laptops Severs, and IT related equipment.
  • Coordination with Vendor any hardware issues and ISP vendor to fix network related issues.
  • Attend and resolve day-to-day issues requirements from all the users.
  • Installation and configuration of TFS Servers, MS-SQL Server & Oracle Databases.
  • Knowledge on Linux with Oracle (Optional).
  • Basic knowledge of Fortigate 100D Firewall and Patching through WSUS..
  • Experience in maintaining and troubleshooting of Windows Server 2008/2012/2016, Client Windows 10 OS.
  • Basic knowledge on configuration of Databases SQL-Server 2008/2012, Oracle-11/12c.
  • Any Microsoft Certifications, Knowledge of Linux, office 365 admin console, SharePoint administration, Fortigate Firewall and Azure Cloud will be added advantage.

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