Senior Consultant

Regulatory System Implementation, R&D, Remote

Confirmed live in the last 24 hours

Locations

Philadelphia, PA, USA

Experience Level

Entry

Junior

Mid

Senior

Expert

Desired Skills

Agile

Management

SAP Products

Oracle

Salesforce

Communications

Requirements

10+ years experience working with life sciences companies
System implementation experience either as a consultant, business, or IT representative for at least one of the following systems: Document Management (Documentum, OpenText, Sharepoint), Registration Data Tracking Systems, XEVMPD, IDMP, SPL, eCTD
Labeling, Submission Publishing and/or Viewing systems
In-depth knowledge of drug development processes and regulatory submissions
Proven ability to collaborate with diverse stakeholders and ensure delivery to a high degree of satisfaction
Excellent communication skills - written, verbal and formal presentation
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 fast-paced environment
You may reside anywhere in the US with easy access to an airport. Ability to travel 40-70%
4-year degree required
Qualified candidates must be legally authorized to be employed in the United States. Veeva Systems does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position

Responsibilities

Lead software implementation projects at life sciences companies ranging from the world's largest pharmaceutical companies to emerging biotechs
Lead the solution design for how your customer will implement and use the Vault Regulatory suite (Vault Registrations, Vault Submissions, Vault Submissions Archive, Vault Publishing)
Lead requirements workshops, design, prototype, configure and document content management/registration data solutions
Architect multi-year and multi-phased implementation programs to deploy Vault RIM across an organization globally
Program and project management including resource planning, leading and motivating a cross-functional team, and project tracking and forecasting
Primary customer liaison managing communication between the project team, customer, and internal stakeholders
Mentor project team and junior consultants in the R&D Services organization
Work closely with business and IT staff from the clients to understand their requirements. Think critically to help them design the solution they actually need; not just the solution they think they need
Ensure customer success from beginning to end of the engagement lifecycle

Desired Qualifications

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 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)

Veeva [NYSE: VEEV] is the leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, our customers range from the world’s largest pharmaceutical companies to emerging biotechs. Veeva’s software helps our customers bring medicines and therapies to patients faster.

We are the first public company to become a Public Benefit Corporation. As a PBC, we are committed to making the industries we serve more productive, and we are committed to creating high-quality employment opportunities.

Veeva is a Work Anywhere company which means that you can choose to work in the environment that works best for you - on any given day. Whether you choose to work remotely from home or work in an office - it’s up to you.

The Role

Do you want to lead a high-energy team focused on solving complex business problems with technology? Are you an innovator? Do you love to learn and thrive navigating new situations and environments? Come help us transform how regulatory information is managed in Life Sciences! 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 people who are intimate with the legacy business process and technologies used to author documents, build submissions and manage product registrations. We want people ready to challenge the status quo; ready to transform businesses.

Roll up your sleeves! As a key member of our Professional Services team, the Senior Consultant will work side by side with the customers. You will drive the effort to understand the customers’ global regulatory needs, translate requirements into solution design, and define global strategies for deploying our cloud-based solution across the enterprise.

This is a remote, full-time permanent role with Veeva. This is a customer-facing role and we have no work location requirement if you are in close proximity to an airport and able to meet future travel requirements.

Veeva Systems does not anticipate providing sponsorship for employment visa status (e.g., H-1B, OPT) for this employment position.

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 how your customer will implement and use the Vault Regulatory suite (Vault Registrations, Vault Submissions, Vault Submissions Archive, Vault Publishing)
Lead requirements workshops, design, prototype, configure and document content management/registration data solutions
Architect multi-year and multi-phased implementation programs to deploy Vault RIM across an organization globally
Program and project management including resource planning, leading and motivating a cross-functional team, and project tracking and forecasting
Primary customer liaison managing communication between the project team, customer, and internal stakeholders
Mentor project team and junior consultants in the R&D Services organization
Work closely with business and IT staff from the clients to understand their requirements. Think critically to help them design the solution they actually need; not just the solution they think they need
Ensure customer success from beginning to end of the engagement lifecycle

Requirements

10+ years experience working with life sciences companies
System implementation experience either as a consultant, business, or IT representative for at least one of the following systems: Document Management (Documentum, OpenText, Sharepoint), Registration Data Tracking Systems, XEVMPD, IDMP, SPL, eCTD
Labeling, Submission Publishing and/or Viewing systems
In-depth knowledge of drug development processes and regulatory submissions
Proven ability to collaborate with diverse stakeholders and ensure delivery to a high degree of satisfaction
Excellent communication skills – written, verbal and formal presentation
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 fast-paced environment
You may reside anywhere in the US with easy access to an airport. Ability to travel 40-70%
4-year degree required
Qualified candidates must be legally authorized to be employed in the United States. Veeva Systems does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position

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 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

Flexible PTO
Allocations for continuous learning & development
Health & wellness programs

#LI-RemoteUS

#BI-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 [email protected] Position may not be eligible for remote work in Colorado.

1,001-5,000 employees

Website

Cloud computing services for pharmaceutical companies.

Company Overview

Veep's mission is to help R&D, quality, and regulatory teams eliminate inefficiencies and bring high-quality, safe, sustainable products to market without compromising quality. The company builds cloud-based tools for pharmaceutical research.

Benefits

Parental leave
PTO
Free food
Health, dental, & vision insurance
Gym membership reimbursement

Company Core Values

Do the Right Thing
Customer Success
Employee Success
Speed