Consultant - Regulatory Process Management - R&D (Remote) at Veeva

| Boston, MA +2 more | Remote
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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

Become an agent of change in life sciences. Join Veeva’s RIM Process Development team in transforming the way Regulatory teams manage their regulatory information, their submission documents, their product registrations, and the way they correspond with health authorities around the world.

Veeva is looking for Consultants with regulatory expertise and a passion for helping customers improve their process for Regulatory Information Management (RIM), submission management, publishing, and submission archiving. We want team members ready to challenge the status quo; ready to transform businesses.

Roll up your sleeves and dive in! As a member of our RIM Process Development team, the Consultant will work side by side with our customers. You will drive the effort to understand the customer’s current state pain points and process gaps, develop the future state vision to meet their global regulatory needs, define user requirements to inform solution design and develop long-term strategies for ongoing process improvements.

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

  • Work with customer subject matter experts globally, and business leaders to analyze, develop, and implement Regulatory processes that solve business problems and support business needs through the use of the Vault RIM suite (Submissions, Submissions Archive, Registrations, and Publishing)
  • Analyze and document current state business processes, identifying pain points and gaps in process or system functionality as areas of opportunity
  • Formulate recommendations for improvement in business processes and system configuration, develop user requirements to facilitate solutions to achieve the business vision, and address key use cases
  • Lead client process analysis engagements built alignment within the customer user groups and worked as a liaison with the implementation team and/or Veeva product team in a Vault RIM implementation project
  • Coordinate with the Veeva implementation team across multiple phases and workstreams (e.g. solution design and configuration, systems integration, data migration, validation, and training)
  • Develop end-user training strategies and deliver supporting materials (e.g. web-based learning, user guides, etc.) to support system deployment
  • Ensure customer success from beginning to end of the engagement life cycle
  • Identify, define, and deploy best practices through internal Preferred Vault Practices, aligning with industry guidance and maintaining a competitive advantage

Requirements

  • 4+ years of direct experience working with regulatory in life sciences companies
  • System experience either as a consultant, business, or IT representative for at least one of the following systems: Document Management (e.g. Documentum, OpenText, Sharepoint, etc.) Registration Data Tracking Systems, SPL, Publishing Tools (e.g. eCTDXpress, InSight, etc.)
  • Working knowledge of life sciences compliance, regulatory guidance, and sponsor quality assurance requirements
  • Ability to quickly understand business use cases and opportunities for change, to create corresponding process and business model improvements
  • Familiar with governance models for process and system management
  • Experience managing diverse stakeholders and ensure delivery to a high degree of satisfaction
  • Ability and willingness to “roll up your sleeves” to analyze and develop process and training material
  • Proven ability to work independently in a dynamic, fast-moving environment and thrive. You may reside anywhere in the mainland US with easy access to an airport. Ability to travel 40-70%
  • Bachelor’s degree or equivalent 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, PARAXEL/LIQUENT InSight, CSC Regulatory Tracker, ArisGlobal Register, OpenText, SharePoint, Documentum, FirstDoc/FirstPoint, NextDocs, CARA, Extedo eCTD Manager, Trackwise, or other regulatory information management systems or publishing tools
  • Consulting experience, working with a major software vendor or process management consulting group
  • Regulatory Affairs, Regulatory Operations, or Submissions Management background
  • Operational Change Management experience, either having led or supported cross-functional change management programs

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]

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Candidate Location Eligibility:
Boston, MA
New York City, NY

Technology we use

  • Engineering
  • Product
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An Insider's view of Veeva

What are some social events your company does?

Crossix encourages team and company-wide events, so we have activities like happy hours, Escape the Room outings, pizza making as well as field day and community service events.

Sean Bell

Analytics Services Manager

What's the biggest problem your team is solving?

My team is starting to do a lot more work in retail pharmacy, so we need to think about how the goals of retail pharmacy clients differ from pharma clients and how to tailor analyses to provide insights that meet these goals

Kate

Analytics Services Senior Manager

How does the company support your career growth?

From your immediate manager and up, there’s a culture of support that manifests in regular check-ins, growth plans geared towards giving you the kinds of work you’re interested in, and plenty of feedback in both directions.

Hart

Channel Partner Manager

How do you empower your team to be more creative?

Innovation is in our company DNA and everyone on the team is always encouraged to bring new and unique ideas to the table. Our Culture Club also organizes creative initiatives that make our working environment more collaborative and fun.

Asaf

CEO

What are Veeva Perks + Benefits

Culture
Volunteer in local community
Crossix participates in local volunteer activities, including bi-weekly lunches with the AHRC, delivering meals with Meals on Wheels, working with Montefiore Medical Center, etc.
Partners with Nonprofits
Friends outside of work
Eat lunch together
Intracompany committees
Crossix has an incredibly active Culture Club where members come up with creative events and programs from our summer outing to themed happy hours and volunteer opportunities throughout the year.
Open door policy
Team owned deliverables
Team based strategic planning
Group brainstorming sessions
Open office floor plan
Diversity
Dedicated Diversity/Inclusion Staff
Diversity Employee Resource Groups
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Disability Insurance
Dental Benefits
Vision Benefits
Health Insurance Benefits
Life Insurance
Pet Insurance
Wellness Programs
Mental Health Benefits
Retirement & Stock Options Benefits
401(K)
401(K) Matching
Company Equity
Match charitable contributions
Child Care & Parental Leave Benefits
Generous Parental Leave
Flexible Work Schedule
Remote Work Program
Family Medical Leave
Vacation & Time Off Benefits
Unlimited Vacation Policy
Paid Holidays
Perks & Discounts
Casual Dress
Commuter Benefits
Company Outings
Stocked Kitchen
Some Meals Provided
Happy Hours
Fitness Subsidies
Home Office Stipend for Remote Employees
Professional Development Benefits
Job Training & Conferences
Diversity Program
Lunch and learns
Promote from within
Mentorship program
Continuing Education stipend
Time allotted for learning

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