Veeva - MDU

Veeva vault Business Analyst- A/SA

SO Job Description

1.Job title WFH HYBRID - LOOKING FOR BUSINESS ANALYST IN LS REGULATORY

2.Job summary A self-sufficient individual with prior experience in Life Sciences Quality domain and

working knowledge in processes and systems is mandatory. - Good working knowledge of GXP IT

Solutions required - Expert understanding of business process analysis design and system architecture. -

Experience in business requirement gathering by conducting workshops/meetings with client - Creating

a detailed business analysis outlining problems and opportunities and solutions for business planning

and monitor

3.Experience 4to9yrs

4.Required Skills Technical Skills- LS Regulatory Domain Skills-

5.Nice to have skills Techincal Skills- Business Services Business Scorecard MN-REC-Regulatory

Compliance Domain Skills-

6.Technology LS Regulatory

8.Roles & Responsibilities A self-sufficient individual with prior experience in Life Sciences Quality

domain and working knowledge in processes and systems is mandatory. - Good working knowledge of

GXP IT Solutions required - Expert understanding of business process analysis design and system

architecture. - Experience in business requirement gathering by conducting workshops/meetings with

client - Creating a detailed business analysis outlining problems and opportunities and solutions for

business planning and monitoring - Proficient skills in teamwork collaboration facilitation negotiation

working in a global multi-cultural environment - Must be able to surface challenges/risks in time and

ensure that the project deliverables are in time and of high quality. - Adhere to best practices related to

the project - Good communication and documentation skills - Good working knowledge of Veeva Vault

preferably Veeva QMS

Release Manager- A/SA

Job Description / Skills:

 A self-sufficient individual with prior experience in Life Sciences Quality domain and working

 Co-ordinate with different release teams to prioritize different projects ,enhancements and bug

fixes

 Plan the release of project deliverables and release life cycle.

 Collect feedback, drive process improvements, and help deliver projects effectively over time

 Communicate the project-related tasks such as plans, timelines, requirements, etc. between

different teams.

 Coordinate the release schedule and resources required depending upon the third-party

applications, defect backlogs, planned releases, and infrastructure updates.

 Identify the risks that can delay the release and manage them, such that the scope scheduled,

and quality of the release is not affected.

 Track the progress and find issues, if any. Always work to improve the process of release.

 Make sure that the release is planned, according to the requirements and budget.

 Schedule the release readiness reviews before deployment and milestone reviews after each

release.

 Create plans for the implementation and deployment as per the release schedule.

 Plan and give weekly updates on the release activities

 Lead the Go-Live activities to deploy the application changes successfully.

 Team up with relevant development teams responsible for building the automation tools used

to develop and deploy the software.

 Schedule the CAB meetings to discuss the release schedules with the team and find roadblocks,

if any.

 Maintain documentation related to procedures on build and release, various notifications lists,

and dependencies.

 Make improvements in the methodologies used for configuration management and

development of Veeva Vault that helps to find ways to use in configuration management.

 Co-ordiate transisition process between , project, enhancement and run teams

 Prior experience in managing end to end product release including impact analysis ,pre release

environment preparation , managing and co-ordinating regression testing

Veeva vault Promomat- A/SA/M

SO Job Description

Candidate should have experience in Promomat and other modules as well.

1.Job title WFHHYBRID - COGNIZANT LOOKING FOR SR PRODUCT SPECIALIST IN REGULATORY 2.Job

summary Bachelors degree in related area and/or equivalent experience/training. - At least 5 years of

experience of data analyst. - Subject matter expertise with the Vault Promomats features viz o Worked

on creation and maintence of reports. o Multichannel Integrations: CLM Engage and Approved Email

Integrations o RIM to other vaults connection and data flow o Demonstrated experience with Veeva

Vault & related technologies. - Working knowledge of FDA standards GxP - Support the definition of sy

3.Experience 8to9yrs 4.Required Skills Technical Skills- Regulatory Complaince LS Regulatory Domain

Skills- 5.Nice to have skills Techincal Skills- Domain Skills- 6.Technology LS Regulatory 7.Shift Day 09 AM

TO 07 PM IST 8.Roles & Responsibilities Bachelors degree in related area and/or equivalent

experience/training. - At least 5 years of experience of data analyst. - Subject matter expertise with the

Vault Promomats features viz o Worked on creation and maintence of reports. o Multichannel

Integrations: CLM Engage and Approved Email Integrations o RIM to other vaults connection and data

flow o Demonstrated experience with Veeva Vault & related technologies. - Working knowledge of FDA

standards GxP - Support the definition of system user requirements and the team across other

workstreams (e.g. system design and configuration customization data migration and systems

integration) for Veeva Vault application. - Should have expert knowledge in integrating upstream and

downstream system with Veeva Vault - Should be well versed with Pharma validation process -

Knowledge of vault SDK and vault APIs - Desirable knowledge of one or more Object Oriented languages.

Veeva vault Architect- M/SM

SO Job Description

1.Job title WFH HYBRID - LOOKING FOR A VEEVA ARCHITECT 2.Job summary Role: Veeva

Architect - Bachelors degree in related area and/or equivalent experience/training. - At least 10+ years

of eTMF System development and configuration in Veeva Vault experience required - Subject matter

expertise with the Vault Promomats features viz o Compliance Binder Templates & Form Generation o

Multichannel Integrations: CLM Engage and Approved Email Integrations o Auto Claims Linking o RIM to

PromoMats Vault Connection o Multichannel Features like Create Presentation Copy 3.Experience

10to14yrs 4.Required Skills Technical Skills- Regulatory Compliance LS Regulatory Domain Skills- 5.Nice

to have skills Technical Skills- Domain Skills- 6.Technology LS Regulatory 7.Shift Day 9AM TO 6PM(IST)

8.Roles & Responsibilities Role: Veeva Architect - Bachelors degree in related area and/or equivalent

experience/training. - At least 10+ years of eTMF System development and configuration in Veeva Vault

experience required - Subject matter expertise with the Vault Promomats features viz o Compliance

Binder Templates & Form Generation o Multichannel Integrations: CLM Engage and Approved Email

Integrations o Auto Claims Linking o RIM to PromoMats Vault Connection o Multichannel Features like

Create Presentation Copy to Another Vault CRM Vault Metadata Sync CRM Publishing Multichannel

Loader etc - Demonstrated experience with Veeva Vault & related technologies. - Working knowledge of

FDA standards GxP Provided solution to multiple customers. - Support the definition of system user

requirements and the team across other workstreams (e.g. system design and configuration

customization data migration and systems integration) for Veeva Vault application. - Should have

functional and technical knowledge of learning management systems. - Should have expert knowledge

in integrating upstream and downstream system with Veeva Vault - Should be well versed with Pharma

validation process - Knowledge of vault SDK and vault APIs - Good understanding of Spark based Veeva

integrations - Desirable knowledge of one or more Object Oriented languages

 Design and implement solution with experience related to Configuration /Integration/Migration.

 Subject matter expertise with the Vault Vault features viz, multi document change control ,

CAPA etc .

 Demonstrated experience with Veeva Vault related technologies.

 Extensive knowledge and application of FDA standards, GxP

 Support the definition of system user requirements and the team across other workstreams

(e.g. system design and configuration, customization, data migration and systems integration)

for Veeva Vault application.

 Should have experience in EDL (Expected Document List) management, Configuration of new

sites, user access provisioning, UAT testing etc.

 Should have functional and technical knowledge of learning management systems

 Should have expert knowledge in integrating upstream and downstream system with Veeva

Vault

 Should have experience in User Access Management, platform support, triaging incidents, root

cause analyzing problem tickets, assessing & estimating requests for change, tracking

escalations and working with vendors to resolve system issue

 SME knowledge of vault SDK and vault APIs

 Good understanding of Spark based Veeva integrations.

Project Manager- M

SO Job Description

1.Job title WFH HYBRID - LOOKING FOR A PROJECT MANAGER 2.Job summary Role:

Project Manager - Bachelors degree in related area and/or equivalent experience/training. -

Responsibility for Delivery. Deliver Project with initiation planning delivery monitoring reporting closure

Define SoW budget stakeholder & risk framework. Resource planning & contracts management Incident

& Change Management Baseline Variance. Define Lifecycles for Fixed cost & T&M Projects. Plan for

Invoicing Revenue & Project Collection Cash Flow P & L. Conduct Scrum Release Plan

3.Experience 10to13yrs

4.Required Skills Technical Skills- Regulatory Compliance LS Regulatory Domain Skills- 5.Nice to have

skills Technical Skills- Domain Skills-

6.Technology LS Regulatory

7..Roles & Responsibilities Role: Project Manager - Bachelors degree in related area and/or equivalent

experience/training. - Responsibility for Delivery. Deliver Project with initiation planning delivery

monitoring reporting closure Define SoW budget stakeholder & risk framework. Resource planning &

contracts management Incident & Change Management Baseline Variance. Define Lifecycles for Fixed

cost & T&M Projects. Plan for Invoicing Revenue & Project Collection Cash Flow P & L. Conduct Scrum

Release Plan Sprint Plan Sprint Reviews Retrospectives. Reporting for program/project Define Project

plan Project scope plan resources execution track activities monitor conflicts & escalations People

Management Create Risk Management framework Generate MBR/WSR/Daily reports.

1) Job Summary for Veeva Vault Administrator:

The System Administrator, Veeva Vault primarily will support the Veeva Vault platform, including

QualityDocs, QMS, RIM, and Clinical. The System Administrator, Veeva Vault participates in the project-

drive activities to capture business needs, processes, requirements, use cases, project plans, and related

documentation and specifications.

The System Administrator, Veeva Vault works effectively with business and technical resources, bringing

an enterprise, cross-functional perspective to the project team(s), resulting in unified business

requirements and streamlined processes.

The System Administrator, Veeva Vault may also make significant contributions to team effectiveness by

improving the methodology, tools, and/or internal processes.

RESPONSIBILITIES:

 Primary system administrator for the day-to-day administration of Veeva Vault

 Monitor alerts and troubleshoot critical production issues impacting end users

 Discover requirements underlying feature requests, align them with alternative technical and

business approaches, and work with business and technical teams to develop solutions that

meet goals and requirements

 Lead end-to-end solutioning for Veeva Vault platform in partnership with the business

stakeholders and third-party service providers.

 Configure and troubleshoot lifecycles, workflows, security settings, objects, and documents.

 Manage user access provisioning and de-provisioning for the Veeva Vault platform

 Manage Veeva Vault platform and end-user licensing in partnership with the business

stakeholders

 Act as single point of contact for resolution of Veeva Vault platform issues by coordinating with

the business, IT Managed Services Provider (MSP), and other third-party service providers

 Analyze, implement, and document change and service requests

 Manage high priority requests and application downtime (planned & unplanned)

 Ensure all Veeva modules remain fully validated during scheduled updates

 Perform Veeva release impact analysis and manage configuration management

 Mentor and train functional area teams on Veeva Vault platform adoption

 All other job-related duties as it relates to the job function or as delegated by the management

team

 Other duties as assigned.

EXPERIENCE

 A minimum of 5-8 years of experience on Veeva Vault at a life sciences, biotech, or

pharmaceutical company providing business analysis and application implementation/support in

a fast-paced, demanding environment

 Experience with Vault loader and VQL strongly preferred

 Subject matter expertise in at least two Veeva Vault modules such as QualityDocs, QMS, RIM,

CTMS, and eTMF

 Experience implementing Veeva Vault products in a GxP environment

 Expertise in solution architecture design, technical integration design and Veeva Vault platform

best practices

 Thorough understanding of system validation and change management

 Strong analytical, consulting, and problem-solving skills

 Certifications in Veeva Vault Administration strongly preferred

 Natural collaborator who enjoys working on a cross-functional team

 Good to have Vault SDK experience .

2) Job Summary for Veeva Vault RIM:

 Must have experience in the Veeva RIM Registrations module or at least Veeva RIM/QMS

implementation experience.

Responsibilities and Experience:

 5 to 7+ years' experience in Veeva Regulatory Information Management systems and

Pharma/Biotech Drug Manufacturing Process.

 Analyze current state challenges with Regulatory Affairs CMC and QA (both Clinical and

Commercial) business process – in the areas of planning, submission, and batch release

 In-depth understanding of Regulatory process, for both clinical and commercial, as well as US

and EU regulatory process and how it impacts the key business processes regarding initial

application filings, clinical study changes, and post-marketing changes, etc.

 Develop a future business process for RA CMC data entry and QA batch release related to

planning, submission, and batch release – in lieu of current state challenges and areas of

improvement

 Facilitate workshops designed to define and document core business processes focusing on

client's Regulatory Affairs CMC and QA future requirements

 Define future approach to implement out of the box Product Docket/ Regulatory Information

Management packaged software

 Highlight and prioritize pain points across people, process, data, and technology and identify

opportunities for improvement across end-to-end Regulatory, Supply Chain, and Quality

business process

 Author critical deliverables within the business process workstream e.g. SIPOCs, KPIs/metrics,

and Process Maps, GPID implementation roadmap

 Help develop/refine Key Performance Indicators, metrics, and criteria to measure and assess RA

CMC and QA operational performance

 The ideal candidate must have hands-on experience in implementing the Veeva RIM

Registrations module or at least Veeva RIM/QMS implementation experience.

3). Job Summary (Quality Systems Consultant VEEVA):

We are looking for versatile leaders and innovators with 5 -8 years of prior industry or Techno-

functional experience.

RESPONSIBILITIES:

 Focus on business process re-engineering efforts and regulatory compliance

 Earn trusted client status and develop relationships that extend beyond the

project’s life cycle

 Participate in projects at life sciences and consumer products companies designing

and deploying Quality systems

 Rapidly configure and implement the Vault Quality suite (Vault QMS, Vault

QualityDocs) which is used to manage quality process and content in the cloud

 Lead requirements workshops, design, prototype, configure and document content

management/QMS data solutions

 Create and oversee project plans and timelines, define project deliverables, assign

project team roles and resources, identify and track issues and their resolution, and

manage project scope and requirements.

 Assist in validation of computer systems for use in a Good Manufacturing Practices

(GMP) environment and creating and revising Standard Operating Procedures

(SOPs)

 Conduct knowledge transfer and training of end-users, including sharing best

practices

 Provide guidance to junior systems analysts and client personnel assigned to

projects

EXPERIENCE

 4 to -8+ years of experience working with or for life sciences companies with Veeva

QMS.

 Experience implementing Document or Quality Management systems for life

sciences as a consultant, business or IT representative

 Understanding of global quality requirements, compliance considerations and

processes for Quality process and content management, life sciences compliance,

and/or computer systems validation

 Firsthand experience with systems such as Veeva Vault quality information or

content management systems

Title : Veeva Vault eTMF/Clinical ___

Job Description / Skills:

 Bachelor's degree in related area; and/or equivalent experience/training.

 At least __ years of eTMF System development and configuration in Veeva Vault experience

required, including experience in study start-up, system setup, maintenance and closeout

activities.

 Subject matter expertise with the TMF Reference Model, clinical trial activities and related

terminology.

 Demonstrated experience with CTMS, EDC, and eTMF technologies.

 Extensive knowledge and application of ALCOA FDA standards, Good Clinical Practice, and Good

Documentation Practice, per ICH (E6 (R2).

 Support the definition of system user requirements and the team across other workstreams

(e.g. system design and configuration, customization, data migration and systems integration)

for Veeva Vault eTMF application.

 Should have experience in EDL (Expected Document List) management, Configuration of new

sites, user access provisioning, UAT testing etc.

 Direct system implementation experience either as a consultant, business or IT representative

for at least one of the following systems: eTMF, CTMS, Study Startup, or eRegulatory/ISF.

 Enable new processes, system deployment, and continuous improvements by defining a roll-out

strategy and post-live governance

 Should have experience in User Access Management, platform support, triaging incidents, root

cause analyzing problem tickets, assessing & estimating requests for change, tracking

escalations and working with vendors to resolve system issues.

 Demonstrated understanding of the clinical study phases involved in Drug Development and the

corresponding records requirements, in accordance to federal regulations.

 Thorough knowledge and ability to apply all relevant regulatory guidelines, regulations, policies,

and federal guidance documents.

 Highly proficient in CTMS and eTMF technologies. Experience and skills in navigating eTMFs

preferred.

 Should have experience in eTMF system migration & incident management, Process

Management, Service task Management at L1/L2/L3 Levels for Veeva applications.

 Demonstrated experience in developing the study specific environment, creating sites/

milestones/artifacts/metadata fields/reports/workflows/lifecycles etc. in production area.

 Able to conduct trainings on eTMF system maintenance and configuration for the study team

members.

 Maintain the TMF in a state of audit readiness for quality and compliance.

 Should be able to help support the records archival team & Project Managers on study closure

and transferring the data back to client.

 Experience in middleware based Veeva Vault integrations and Veeva Vault related migrations .

 Good to have Vault SDK development experience

Veeva Vault Support Consultant (L2&L3 support):

Project name: Veeva Vault PromoMats • Legal entity : NN GBS • Cost Centre: 402-23243 • Experience

Level: Junior resource. Around 3 years in IT, 1-2 years hands on Veeva Vault configuration experience

(preferably PromoMats) • Onsite/Remote: Hybrid • Number of consultants: 01 (One) • Tenure: 1 year to

start with • Hiring Manager: SPRJ • Service Type: Consultant • Skill Area: o Veeva Vault; o PromoMats or

any other vault configuration experience; Understanding of different configurations and workflows; o

Familiarity with user access management o Strong written, verbal, and organizational skills to interface

with technical peers and business stakeholders across various workstreams. • Main Technology: Veeva

Vault • Mandatory Skills: (Must Have Skills) – Vault configuration • Optional Skills: (Good to Have Skills)-

Experience and/or training in the implementation of various SaaS solutions • Roles & Responsibilities: o

Veeva Vault PromoMats configuration, user access management, day to day operations and

maintenance of the application.