Senior Consultant - Regulatory Operations Software Implementation (Remote)

About the role

Lead life science customers in the configuration and implementation of Veeva’s Regulatory suite (Veeva Registrations, Veeva Submissions, Veeva Submissions Archive, Veeva 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 Veeva best practices, customer success, 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 continuous growth.

Responsibilities

• Lead life science customers in the configuration and implementation of Veeva’s Regulatory suite (Veeva Registrations, Veeva Submissions, Veeva Submissions Archive, Veeva 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 Veeva best practices, customer success, 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 continuous growth
• Collaborate cross-functionally with Product, Strategy, Sales, and other teams across Veeva

Requirements

• 8+ years experience working with or for organizations in life sciences or healthcare
• Direct technology system implementation, maintenance, or continuous 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

Qualifications

• Typical travel is 25% but may be up to 50% based on customer requirements
• 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 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/Cloud experience

Skills

• 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

Benefits

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

Pay

Base pay: $80,000 - $200,000

Schedule

Flexible work schedule

Company Information

Veeva is a Public Benefit Corporation (PBC) that believes in giving back. Veeva’s support for charitable causes is entirely employee driven because we think giving is personal and should be directed by the individual. With our 1% Veeva Giving program, each employee receives an amount equivalent to 1% of their base salary annually to support the non-profit(s) of their choice. We don’t dictate favored corporate causes or ask employees to donate to specific non-profits. We never support a charitable cause in exchange for commercial advantage or preferential treatment.

Company Culture

Veeva’s core values — do the right thing, customer success, employee success, and speed — guide our decision making and define our culture. Doing the right thing means that we are concerned about more than just financial success and return to shareholders. We recognize a responsibility to customers, employees, environment, and society. As individuals, we pride ourselves on being good people who are honest, fair, and direct. We treat others with respect. As a company, we strive to be a good corporate citizen, a positive force in the business community, active in our communities, and an example to others.

Equity Program

Veeva has taken a strong stance against the use of non-compete agreements that can limit employee opportunities. We do not require our employees to sign non-compete agreements, and we have taken legal action to fight the unfair use of these agreements by other companies because we believe such agreements limit an employee’s fundamental right to work where they choose. We believe in our people and want them to be successful here at Veeva or wherever their careers take them.