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 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 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, 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 Training, Report Automation, Reviewing Literature, Standard Operating Procedure (SOP) {+ 2 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

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

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. 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

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

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.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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:

Domestic

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

07/6/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.