Associate Director, Lead Engineer - Veeva RIM

Job Description

Part of the AH IT strategic plan to reduce bottom line costs and insource critical positions.

Required Skills:

Data Engineering, Data Visualization, Design Applications, Software Configurations, Software Development, Software Development Life Cycle (SDLC), Solution Architecture, System Designs, System Integration, Testing

Preferred Skills:

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Secondary Language(s) Job Description:

Lead Engineer Veeva Vault RIM

The Opportunity

• Based in Hyderabad, join a global healthcare biopharma company and be part of a 130- year legacy of success backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
• Be part of an organisation driven by digital technology and data-backed approaches that support a diversified portfolio of prescription medicines, vaccines, and animal health products.
• Drive innovation and execution excellence. Be a part of a team with passion for using data, analytics, and insights to drive decision-making, and which creates custom software, allowing us to tackle some of the world's greatest health threats.

Our Technology Centers focus on creating a space where teams can come together to deliver business solutions that save and improve lives. An integral part of our company's’ IT operating model, Tech Centers are globally distributed locations where each IT division has employees to enable our digital transformation journey and drive business outcomes. These locations, in addition to the other sites, are essential to supporting our business and strategy.

A focused group of leaders in each Tech Center helps to ensure we can manage and improve each location, from investing in growth, success, and well-being of our people, to making sure colleagues from each IT division feel a sense of belonging to managing critical emergencies. And together, we must leverage the strength of our team to collaborate globally to optimize connections and share best practices across the Tech Centers.

Role Overview

We are seeking a Lead Engineer — Veeva Vault RIM to join our Regulatory Platforms team within R&D IT. In this technical leadership role you will lead the configuration, development, and optimization of our Animal Health Veeva Vault Regulatory Information Management (RIM) platform to support pharmaceutical and biological development globally. You will translate regulatory and business requirements into scalable, compliant Vault configurations, automations, and integrations. You will own technical delivery across the RIM roadmap—leading sandbox builds, release execution, and validation activities—while mentoring other RIM specialists and collaborating with cross-functional stakeholders to ensure solutions meet product, regulatory, and quality standards.

What will you do in this role

• Lead the design, build, and implementation of Veeva Vault RIM configurations (objects, object types, lifecycles, workflows, role/permission models, document types, metadata and page layouts) that meet enterprise regulatory requirements.
• Implement Vault automation (entry actions, user actions, validation rules, workflow steps, object actions, and permission rules) to streamline regulated workflows and accelerate business processes.
• Develop advanced reports and dashboards; optimize search, metadata, and taxonomy to support regulatory use cases and improve discoverability for global regulatory teams.
• Maintain concise configuration documentation including requirements traceability, design specifications, and configuration logs to ensure audit readiness.
• Design and implement integrations between Vault RIM and upstream/downstream systems using Vault REST APIs, web services, middleware (e.g., Boomi or MuleSoft), and secure file transfer mechanisms.
• Lead data management practices: use Vault Loader effectively, implement data quality controls, align master/reference data (products, substances, organizations) and support IDMP/SPOR-related data standards.
• Own release execution for configuration changes and platform updates: sandbox builds, migration to test/production, deployment scripts, release notes, and cutover/rollout activities.
• Support computer system validation (CSV) for GxP‑relevant changes: co-author design and test plans, produce test scripts, capture evidence, manage deviations, and support QA reviews consistent with GAMP 5 and internal SOPs.
• Provide Tier 3 technical support for complex Vault issues, perform root-cause analysis, and drive corrective actions to resolution.
• Mentor and guide RIM analysts and junior configurators; perform configuration reviews to ensure quality, compliance, and alignment with platform standards.
• Evaluate new Vault RIM features and releases; provide technical impact assessments and implementation plans to inform roadmap decisions.
• Collaborate with business and IT stakeholders (Regulatory Affairs, CMC, Labeling, Clinical, PV, QA, Compliance, Security, Platform Owner, and Architects) to ensure Vault solutions meet business needs and regulatory obligations.

What should you have

• 7+ years of hands-on Veeva Vault RIM technical configuration and development experience across core modules (Registrations, Submissions, Submissions Archive).
• Expert-level Vault configuration skills including lifecycles, workflows, permissions, automation, document/object models, metadata, and reports/dashboards.
• Proven experience delivering integrations via Vault REST APIs, web services, middleware (Boomi/MuleSoft), and secure file transfer; strong understanding of data mapping, transformation, and error handling.
• Practical experience with Vault Loader and bulk data migration approaches.
• Strong working knowledge of regulatory processes for pharmaceuticals and biologics (global submissions, variations, renewals) and related data structures (IDMP/SPOR).
• Demonstrated competence in computer system validation (CSV) for GxP systems: test design, execution, evidence management, and change control.
• Excellent troubleshooting, documentation, communication, and stakeholder engagement skills; experience mentoring and reviewing technical work.
• Bachelor’s degree in Computer Science, Information Systems, Life Sciences, or equivalent experience.

Preferred

• Experience with Veeva Vault eTMF and/or Clinical modules.
• Veeva Vault Administrator and RIM certifications.
• Prior experience in medium-to-large pharma/biotech organisations with multinational regulatory operations.
• Familiarity with labeling workflows, CMC data flows, and integrations to Quality, Safety, and Clinical systems.
• Experience with data governance, controlled vocabularies, and reference data frameworks (IDMP/SPOR).

This role represents an exceptional opportunity to lead and influence the global RIM platform for Animal Health, enabling faster, compliant regulatory submissions and stronger data integrity across the organization. If you’re passionate about building robust, scalable regulatory platforms and mentoring a team of specialists, we invite you to apply!

Primary skills: expert Veeva Vault RIM configuration and integration

Secondary skills : Technical leadership, GxP

Who we are

We are known as well-known org Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

#HYDIT2025

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

04/30/2026

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