Senior Essential Document Specialist - Remote

Job Description

The Senior EDS will serve as a liaison between the EDS team and the EDL Lead/EDM. They support strategies, procedures and tools for the optimization of EDM processes. In addition to performing tasks of the Essential Document Specialist (shown below), the Senior EDS will also be responsible for onboarding new EDS employees as well as coordinating, leading and execution of EDS tasks as well as additional tasks to support EDS operations while acting as a Subject Matter Expert (SME).

Essential Document Specialist Responsibilities:

• Support Essential Document Leads and Manager

• Support strategies, procedures, and tools for the optimization of the processes.

• Applies creative solutions to complex site ready situations and demonstrates situational leadership within cross functional teams.

• Interact with external partners for programmatic and functional sourcing.

• Recognizes and considers various solutions to problems or situations.

• Execution: Works with internal/external partners to assure document processing times are maintained; Monitors/tracks compliance of study essential documents; Ensures the integrity of the essential clinical trial documents (both hardcopy and electronic) within the Official Regulatory files.

• Internal/External Interactions: Ensures proper communication with external partners, stakeholders, and customers; Liaises with clinical teams and external partners to achieve site ready timelines; Interfaces with staff members to provide support and guidance.

• Performance Tracking: Identifies and reviews metrics to assure process remains efficient and effective audit and Inspection Support: Works with inspection support teams to ensure inspection process readiness.

• Assists in retrieval of documentation during sponsor inspections.

• Supports the development of responses to audits and inspections and ensures appropriate implementation.

• Ensures that all actions and commitments are implemented in a timely manner.

Education Requirements:

• Bachelor’s degree required.

Computer Skills:

• Intermediate level in Adobe Acrobat including knowing how to edit, extract and redact pages

• Microsoft Office Suite 2010 or higher,

• Beginner to Intermediate experience level in WORD

• Intermediate experience level in EXCEL

• Intermediate experience level in Outlook

Experience:

• A minimum of 3 years as an Essential Document Specialist and at least 5 years of relevant experience in clinical research.

• General knowledge of ICH-GCP and other relevant regulations pertaining to essential documents.

• Must have intermediate understanding of the functional area responsibilities associated with the clinical development process, trial management, and clinical trial management systems, as well as quality management and control tools.

Required Skills:

Adaptability, Clinical Documentation, Clinical Site Management, Clinical Trial Compliance, Clinical Trial Documentation, Clinical Trial Management Processes, Clinical Trial Planning, Clinical Trials, Clinical Trials Monitoring, Clinical Trials Operations, Cross-Cultural Awareness, ICH GCP Guidelines, Inspection Readiness, Performance Tracking, Process Optimization

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:

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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

$117,000.00 - $184,200.00

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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Remote

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

No

Job Posting End Date:

05/23/2026

***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. **