Specialist, Medical Services/Writing

Job 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 document management, publishing, and other tools, the Specialist will support Preclinical Development (PCD) end‑user operations in Veeva and development of internal processes and tools to optimize document functions. The specialist will also participate in the design, development, operationalization & rollout and/or support of automation capabilities supporting document generation and management in PCD.

Responsibilities

Constructing, supporting, and managing regulatory documents and components.

Active participation in use, support, and implementation of document management systems, tools, and automation capabilities that enable effective and compliant document management in PCD.

Careful collaboration with internal and external stakeholders.

Quality review to ensure that regulatory documents are appropriate, complete and consistent with regulatory expectations.

Minimum qualifications required

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

MS/MA, including degrees in biological, chemical, computer science, and/or medical science disciplines and a minimum 2 years direct and relevant experience.

Required experience and skills

Experience with nonclinical drug development

Significant experience with Microsoft Office Suite and related computer systems tools

Significant attention to detail and quality attributes

Solid command of English grammar, and robust editing & proofreading skills.

Strong candidates will demonstrate good leadership skills as well as the ability to work and communicate effectively

Preferred experience & education

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 desired.

Experience with report automation (technical design, development, operation, implementation)

Experience with publishing tools

Have a solid understanding of applicable GxP regulations (highly preferred)

Required Skills

Change Catalyst

Compliance Implementation

Compliance Remediation

Computer Science

Detail-Oriented

Document Management

Drug Development

Electronic Document Management System (EDMS)

Good Laboratory Practices (GLPs)

Information Management

Information Systems Management

Internal Processes

Literature Development

Microsoft Office

Policy Interpretation

Proper Grammar

Publishing

Regulatory Documents

Regulatory Reporting

Regulatory Submissions

Regulatory TrainingReport Automation

Reviewing Literature

Standard Operating Procedure (SOP)

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 EEOC Know Your Rights or EEOC GINA Supplement. We are proud to be a company that embraces the value of bringing together talented, committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts.

The salary range for this role is $96,200.00 - $151,400.00. The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include 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 about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

Job Posting End Date: 07/6/2026

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