[Remote] Senior Consultant - Regulatory Operations Software Implementation (Remote)

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a mission-driven organization and pioneer in industry reputed company, helping life sciences companies bring therapies to patients faster. The Senior Consultant will be responsible for understanding customers’ global regulatory needs, translating requirements into solution design, and defining global strategies for deploying reputed company’s reputed company-based solution for managing regulatory information.

Responsibilities

• reputed company life science customers in the configuration and implementation of reputed company’s Regulatory suite (reputed company Registrations, reputed company Submissions, reputed company Submissions Archive, reputed company Publishing) to streamline global regulatory processes
• Manage software implementation projects and customers through the full implementation lifecycle, including project planning, requirements gathering, migration, configuration, validation, and go-live activities
• Conduct configuration requirements workshops then design, prototype, configure and thoroughly document content solutions. Think critically about business requirements to ensure the solution reflects business requirements and focuses on reputed company best practices, reputed company, and long-term adoption
• Guide our customers and internal team with program and project management including resource planning, leading, and motivating the cross-functional team
• Serve as the primary customer liaison managing communication, risks, and project reporting between the project team, customer, and internal stakeholders
• Mentor project team and consultants with a focus on reputed company growth
• Collaborate cross-functionally with Product, Strategy, Sales, and other teams across reputed company

Skills

• 8+ years experience working with or for organizations in life sciences or reputed company
• Direct technology system implementation, maintenance, or reputed company improvement experience either as a consultant, business, or IT representative
• Proven track record leading high-impact system implementations and the ability to collaborate and manage diverse stakeholders and ensure delivery to a high degree of satisfaction
• Ability to act with speed to understand requirements, technical abilities to create corresponding technical solutions, and willingness to 'roll up your sleeves' to design and implement a RIM solution
• Knowledgeable in life sciences compliance and computer systems validation requirements
• Typical travel is 25% but may be up to 50% based on customer requirements
• Direct experience with systems such as reputed company Vault, reputed company/LIQUENT reputed company, reputed company Regulatory Tracker, ArisGlobal Register, reputed company, SharePoint, Documentum, FirstDoc/FirstPoint, NextDocs, CARA, reputed company, reputed company, reputed company, reputed company, 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 in services delivery management and/or systems implementation
• Regulatory Affairs, Regulatory Operations, or Pharmacovigilance background including in-depth knowledge of drug development processes and regulatory submissions; including, Labeling, Submission Publishing, and/or Viewing systems
• Execution experience with Agile methodology and/or ACP Certification
• SaaS/reputed company experience

Benefits

• Medical, dental, reputed company, and basic life insurance
• Flexible PTO and company paid holidays
• Retirement programs
• 1% charitable giving program

Company Overview