Senior Business Analyst - Pharma R&D

Wicresoft

The business analyst will support delivery of key R&D projects business requirements and be experienced with regulatory and GxP practices.

  • Business Analyst
  • R&D
  • Pharma/GxP
The Senior Consultant Business Analyst, works closely with the business and technical teams and is a major contributor to the support and delivery of key  Research & Development projects business requirements, which may also include data and report requirements using SDLC practices. Must have very strong R&D with complex applications. These projects are very involved, using SAS, SDMS, Imaging DB.  Must be able to  come in and hit the ground running.  This role will work within the IM Business Solutions group to support project delivery in partnership with the IM PMO (Information Management, Project Management Office) and R&D project teams to ensure the business process is translated into business, functional and design requirements to successfully test and implement technology.  This includes supporting the user acceptance test planning process, if required, test script development, to ensure the required business functionality works as expected.   

 
The Position will maintain engagement with the R&D business unit, encompassing, i.e., Biometrics, Business Technology Management, Clinical Data Management, Clinical Operations, Research & Drug Discovery, Development Sciences Operations, Pharmacological Sciences, Regulatory and Medical Affairs. 
The consultant will take direction from the Project Manager(s) and work with project teams made up of business users, system owners, and IM resources from other technical functions, as well as working independently. This position will ensure system, process, data, user requirements are documented, implemented to meet the business needs within the defined project timelines.   
 
RESPONSIBILITIES 
 
    
Operational / Tactical: 
  • Works across business functions to facilitate requirements gathering process. 
  • Author key documents, including Requirements, Process Flows (As/Is, To/Be), Use Cases, Test Scripts, User Manuals and Training materials, and various other technical documents. 
  • Identify/analyze business processes, data, and reporting requirements.  
  • Act as technical liaison between the business stakeholders, vendors and other members within the IM group. 
  • Follow SDLC process.  
  • Support Issue identification and resolution. 
  • Support BA deliverables within R&D technology projects GXP and non-GXP. 
 Skill Profile 
  Competent at eliciting and documenting business requirements/processes.  
  • Ability to evaluate information from multiple sources, reconcile conflicts, distinguish presented user requests from the underlying true needs and distinguish solution ideas from requirements. 
  • Excellent communication and team building skills with an ability to balance, negotiate and work with a variety of internal and external stakeholders to build strategic partnerships. 
  • Experience with off-the-shelf and custom application SDLC practices. 
  • Ability to simultaneously manage and deliver on multiple competing priorities.  
  • Perform well with ambiguity and drive results in a fast-paced, rapidly changing environment. 
  • Understanding of drug development processes. 
  • Attention to detail and good analytical skills are essential. In addition, critical thinking, and strong problem-solving skills are a must. 
    
EXPERIENCE 

Required  

  • R&D complex application ; SAS, SDMS, Imaging DB
  • 5+ Years of business analysis supporting requirements gathering, business process mapping and system implementations 
  • Leading and facilitating requirements gathering sessions with cross functional groups 
  • Experience in working in a regulated environment (i.e., FDA) and understanding of computer system validation practices and principles (IQ/OQ/PQ – 21 CFR Part 11). 
  • Experience with GxP applications within the Pharmaceutical/BioTech industry.  
  • Hands-on experience with HP-ALM to author and manage requirements, and test scripts. 
  • Has successfully worked in a project team environment 
  • Can work independently with limited direction and be a self-starter in learning new business processes and systems 
  • BA or BS Degree
  • Deep knowledge of project BA experience – complex applications – the projects are very involved, complex –
  • SAS, SDMS, Imaging DB
  • We are looking for a Sr BA, someone who can come in, hit the ground running with little support
 
Nice-to-have 
  • Experience with NuGenesis. 
  • Experience with ELN. 
  • Experience with EDC applications from various vendors, i.e., Medidata, Veeva. 
  • Experience with lab research images database applications. 
  • Data analysis skills. 
  • Business Analysis (BABOK) certification.