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

Management

Communications

Requirements

3+ years of experience working with or for Life Sciences companies; including, Pharmaceutical, Biotechnology, Healthcare, and Medical Device and Diagnostics organizations with knowledge of drug development processes and regulatory submissions
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
Submission Publishing and/or Viewing systems
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
Technical abilities and willingness to “roll up your sleeves” to design and implement a RIM solution
Ability to work independently in a fast-paced environment
Ability to travel 40-70%; easy access to an airport
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

Play a critical role on software implementation projects at life sciences companies ranging from the world's largest pharmaceutical companies to emerging biotechs
Rapidly configure and implement the Vault RIM suite (Vault Registrations, Vault Submissions, Vault Submissions Archive, Vault Publishing) which is used to manage regulatory affairs and regulatory operations content and data in the cloud
Lead requirements workshops, design, prototype, configure and document content management/registration data solutions
Perform project management tasks including resource planning, leading and motivating a cross-functional team, and project tracking and forecasting
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 life cycle

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, 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 Pharma covigilance background
Knowledge of Medical Device and Diagnostics regulatory processes, data and content
Knowledge of Software Validation processes and requirements
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 love solving 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! Veva’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 Life Sciences Consultants with system implementation experience and a passion for helping customers optimize their regulatory data and document management process.

As a key member of our Professional Services team, the 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.

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

Play a critical role on software implementation projects at life sciences companies ranging from the world’s largest pharmaceutical companies to emerging biotechs
Rapidly configure and implement the Vault RIM suite (Vault Registrations, Vault Submissions, Vault Submissions Archive, Vault Publishing) which is used to manage regulatory affairs and regulatory operations content and data in the cloud
Lead requirements workshops, design, prototype, configure and document content management/registration data solutions
Perform project management tasks including resource planning, leading and motivating a cross-functional team, and project tracking and forecasting
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 life cycle

Requirements

3+ years of experience working with or for Life Sciences companies; including, Pharmaceutical, Biotechnology, Healthcare, and Medical Device and Diagnostics organizations with knowledge of drug development processes and regulatory submissions
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
Submission Publishing and/or Viewing systems
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
Technical abilities and willingness to “roll up your sleeves” to design and implement a RIM solution
Ability to work independently in a fast-paced environment
Ability to travel 40-70%; easy access to an airport
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, 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 Pharma covigilance background
Knowledge of Medical Device and Diagnostics regulatory processes, data and content
Knowledge of Software Validation processes and requirements
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-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