Specialist, Document Systems

Merck & Co.

West Point (PA)

Hybrid

USD 96,200 - 151,400

Full time

14 days+

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Job summary

Merck & Co. seeks a Specialist in Information Management within Nonclinical Drug Safety to coordinate, assemble, and manage regulatory documents for internal studies and external efforts.

The role supports PCD operations in Veeva and crafts internal processes to optimize document functions, collaborating with data scientists on AI-enabled drafting and review. You will contribute to report automation, control document lifecycles, and train end-users while aligning with regulatory expectations and

Qualifications

BS/BA or MS/MA in biological, chemical, computer science, or medical science with direct experience.
Experience in nonclinical drug development and Veeva Vault operations.
Understanding of document lifecycle, metadata, workflows, and records management.

Responsibilities

Coordinate and manage regulatory documents for internal studies and external efforts.
Support PCD end-user operations in Veeva and develop internal processes to optimize document functions.
Collaborate to build tools, train users, and enable AI-assisted drafting and review of reports.
Drive automation, quality reviews, and process improvements for regulatory documents.
Lead end-user training and contribute to cross-functional implementation efforts.

Skills

API Calls

Automation Tools

Content Editing

Content Management

Document Lifecycle Management

GxP Regulations

LLM Evaluation

Python

Regulatory Submissions

Project Planning

Metadata

Education

BS/BA in biological, chemical, CS, or medical science

MS/MA in related disciplines

Tools

Veeva Vault

APIs

Microsoft Office

Job description

Position Description

Within the dynamic environment of Nonclinical Drug Safety (NDS), a Specialist in Information Management works with internal scientific staff and across our Research & Development Division to coordinate, assemble, and manage regulatory documents for internal studies and those acquired from external efforts. Using technical skills in document management, publishing, and other tools, the Specialist will support Preclinical Development (PCD) end‑user operations in Veeva and develop internal processes and tools to optimize document functions. The successful candidate will collaborate closely with NDS data scientists to establish a new, validatable pipeline to leverage generative AI in authoring and reviewing draft reports across the NDS portfolio.

Responsibilities

Actively contribute to report automation efforts by using advanced document management systems skills (e.g., APIs, data structures, and document/content knowledge).
Bring strong process and systems thinking to drive business integration and enable scalable solutions that facilitate the effective and compliant use of generative AI in document generation in PCD.
Collaborate with appropriate specialists to build, implement, and train users on related processes and tools for cross‑functional participation.
Utilize advanced document management skills (e.g., Veeva super user or equivalent) to troubleshoot and resolve issues and recommend process and functionality improvements.
Contribute to the training and skills development of end‑users.
Using document management, publishing, and project planning tools, manage the generation of nonclinical study and supporting documents from creation through to finalization, overseeing required processes, content development & review, and document integration.
Facilitate quality review to ensure documents are appropriate, complete, and consistent with regulatory and company expectations.
Collaborate with internal and external stakeholders throughout the document development and related processes.
Participate in the development and implementation of tools and metrics to understand and improve processes and productivity.

Science Qualifications Required

BS/BA degree including degrees in biological, chemical, computer science, and/or medical science disciplines – a minimum 3 years direct and relevant experience (OR)
MS/MA, including degrees in biological, chemical, computer science, and/or medical science disciplines – a minimum 2 years direct and relevant experience.

Required Experience and Skills

Experience supporting nonclinical drug development programs within the pharmaceutical, biotechnology, or related industry.
Direct, advanced experience with Veeva Vault operations and functions (e.g., super/advanced user, system owner, or equivalent); experience including process design/development, generation of procedural controls, and/or end‑user support.
Strong understanding of document lifecycle management, metadata, workflows, version control, and records management principles.
Some experience with report automation functions and technology (e.g., API calls, data, prompt engineering, strong LLM usage, systems thinking, technical design, development, operation, implementation, business integration, etc.).
Experience with standard document publishing tools.
Proven ability to review, revise, and prepare high‑quality documents with accuracy and consistency.
Excellent leadership skills, written and verbal communication skills (including a strong command of English grammar, editing, and proofreading).
Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and other business‑related computer systems and software applications.
Demonstrated exceptional attention to detail with a strong commitment to accuracy, quality, and compliance.

Preferred Experience & Education

2+ years of experience supporting document management systems, scientific platforms, enterprise content management, or regulated business applications.
Experience with Python, prompt engineering, strong LLM usage – a plus.
Experience gathering business requirements and translating them into technology solutions.
Solid understanding of applicable GxP regulations highly preferred.

Required Skills

API Calls, Automation Tools, Content Editing, Content Management, Detail‑Oriented, Document Lifecycle Management, Document Management Tools, Drug Development, GxP Regulations, Information Management, LLM Evaluation, Metadata, Microsoft Office, Professional Proofreading, Project Document Management, Project Management Planning, Project Planning, Proofreading, Python (Programming Language), Regulatory Affairs Management, Regulatory Compliance, Regulatory Reporting, Regulatory Submissions

Preferred Skills

Current Employees apply HERE
Current Contingent Workers apply HERE

Compensation

Salary range: $96,200.00 – $151,400.00. The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable.

Benefits

We offer a comprehensive package of benefits, including medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information is available at https://jobs.merck.com/us/en/compensation-and-benefits.

Equal Employment Opportunity

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit the EEOC Know Your Rights and EEOC GINA Supplement. We are proud to be a company that embraces the value of bringing together talented and committed people with diverse experiences, perspectives, skills and backgrounds.

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