Senior Consultant - Regulatory Operations Software Implementation (Remote)

Veeva Systems, Inc.; Madison (WI); Remote; USD 80,000 - 200,000; Full time

Job summary

An innovative leader in the life sciences industry is seeking a Senior Consultant to drive software implementation projects. This role offers the chance to work remotely while leading teams through complex regulatory data management processes. You will be at the forefront of transforming how life sciences companies manage their regulatory information, utilizing cutting-edge solutions to enhance efficiency and compliance. Join a mission-driven organization that values employee success and customer satisfaction, and make a meaningful impact in the healthcare sector. If you are passionate about technology and regulatory processes, this opportunity is perfect for you.

Benefits

Medical, dental, and vision insurance

Flexible PTO

Company paid holidays

Retirement programs

1% charitable giving program

Qualifications

• 8+ years in system implementation for life sciences or healthcare.
• In-depth knowledge of regulatory submissions and drug development processes.

Responsibilities

• Lead software implementation projects at major life sciences companies.
• Manage customer communication and ensure project satisfaction.

Skills

System Implementation

Project Management

Regulatory Knowledge

Stakeholder Communication

Problem Solving

Team Leadership

Technical Design

Education

Bachelor's Degree in Life Sciences or Computer Science

PMP Certification

Agile Methodology Certification

Tools

Veeva Vault

Salesforce

Oracle

SAP

SharePoint

Job description

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $2B in revenue in our last fiscal year with extensive growth potential ahead.

At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company – we made history in 2021 by becoming a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors.

As a Work Anywhere company, we support your flexibility to work from home or in the office, so you can thrive in your ideal environment.

Join us in transforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities.

The Role

We are looking for an experienced consultant with deep expertise in navigating customers through complex software implementation. Veeva’s Vault RIM suite is the industry’s only unified software solution that provides fully integrated regulatory information management (RIM) capabilities including data and document management, submission publishing, and archival on a single cloud-based platform.

Veeva Systems is looking for consulting leaders with system implementation experience and a passion for helping customers optimize their regulatory data and document management processes.

As a key member of our Professional Services team, the Senior Consultant will be responsible for understanding our customers’ global regulatory needs, translating requirements into solution design, and defining global strategies for deploying our cloud-based solution for managing regulatory information across the enterprise.

Opportunities are available within the United States for this role, which is a remote position. If a candidate is in close proximity to an airport and able to meet travel requirements, there is no work location requirement. Qualified U.S.-based candidates are encouraged to apply.

What You'll Do

• Lead software implementation projects at life sciences companies ranging from the world's largest pharmaceutical companies to emerging biotechs.
• 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.

Requirements

• 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.

Nice to Have

• 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.
• Locality to major life sciences customer hub (NJ; Boston, MA; San Francisco, CA; Philadelphia, PA; Chicago, IL).

Perks & Benefits

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

Compensation

• Base pay: $80,000 - $200,000
• The salary range listed here has been provided to comply with local regulations and represents a potential base salary range for this role. Please note that actual salaries may vary within the range above or below, depending on experience and location. We look at compensation for each individual and base our offer on your unique qualifications, experience, and expected contributions. This position may also be eligible for other types of compensation in addition to base salary, such as variable bonus and/or stock bonus.

#LI-Remote

Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world.

Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances. If you need assistance or accommodation due to a disability or special need when applying for a role or in our recruitment process, please contact us at [e-mail].