Stellar Consulting Solutions, LLC · 7 hours ago
Lead Software Engineer
United States
Contract
Remote
Senior Level, Lead/Staff
8+ years exp
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Hiring Manager
Deepika Dua
Insider Connection @Stellar Consulting Solutions, LLC
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Responsibilities
Lead software implementation projects at life sciences companies ranging from the world's largest pharmaceutical companies to emerging biotech
Lead the solution design for implementation and use of the Vault Regulatory suite (Vault Registrations, Vault Submissions, Vault Submissions Archive, Vault Publishing)
Lead configuration requirements workshops, design, prototype, configure and document content solutions
Program and project management including resource planning, leading, and motivating a cross-functional team
Primary customer liaison managing communication between the project team, customer, and internal stakeholders
Mentor project team and consultants, helping others improve their consulting skills
Qualification
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Required
8+ years experience working with life sciences or healthcare companies performing system implementation experience either as a consultant, business, or IT representative
In-depth knowledge of drug development processes and regulatory submissions; including, Labeling, Submission Publishing, and/or Viewing systems
Proven ability to collaborate and communicate excellently with diverse stakeholders and ensure delivery to a high degree of satisfaction
Influential; experience leading teams through hard decisions and negotiating compromises
Technical abilities and willingness to “roll up your sleeves” to design and implement a RIM solution
Expert on life sciences compliance and computer systems validation requirements
Ability to work independently in a dynamic environment
Typical travel is 25% but may be up to 50% based on customer requirements
Preferred
Direct experience with systems such as Veeva Vault, PAREXEL/LIQUENT InSight, CSC Regulatory Tracker, ArisGlobal Register, OpenText, SharePoint, Documentum, FirstDoc/FirstPoint, NextDocs, CARA, Salesforce, Workday, Oracle, SAP, Lorenz Docubridge, Extedo eCTD Manager, Master Control, Trackwise, other regulatory information management or submission publishing systems, etc.
Consulting experience, working with a major system integrator or software vendor
Regulatory Affairs, Regulatory Operations, or Pharmacovigilance background
Knowledge of Pharmaceutical, Biotechnology, and/or Medical Device and Diagnostics regulatory processes, data and content
PMP certification
Execution experience with Agile methodology and/or ACP Certification
Life Science, computer science or related degree
SaaS/Cloud experience
Company
Stellar Consulting Solutions, LLC
Stellar Consulting Solutions, LLC, is a boutique business & technology consulting company headquartered in Atlanta, GA.
201-500 employees
H1B Sponsorship
Stellar Consulting Solutions, LLC has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (2)
Funding
Current Stage
Growth StageLeadership Team
Varun Jhanjee
Global CEO & Chief Sales Officer
Company data provided by crunchbase
