Associate Specialist, Regulatory Affairs - Hybrid

Merck; New Jersey; On-site; USD 72,000 - 103,000; Full time

Job summary

Merck in the United States is seeking a Regulatory Affairs professional to support HRM and Veeva Registrations in Global Regulatory Affairs. You will help manage transition, training materials, documentation, reporting, and data governance, working with cross-functional teams to capture requirements and enable ongoing system support.

The role emphasizes change control, process documentation, and user education, with opportunities to contribute to lifecycle management and cross-functional

Qualifications

• Proficient in MS Office (Word/Excel/PowerPoint/Teams).
• Excellent written and verbal communications and attention to detail.
• Strong collaboration and interpersonal skills.
• Ability to work independently to deliver objectives.
• Experience with documentation.
• Experience in website design and development.
• Ability to optimize user experience through research and design.
• Proficient in Veeva Vaults—Veeva Registrations.

Responsibilities

• Transition and maintain process documentation and supporting resources.
• Provide training content and ongoing education support.
• Collect user feedback and implement enhancements; roll out updates to end users.
• Create global HRM communications content and multi-modal delivery.
• Gather requirements with SMEs to ensure timely delivery.
• Support Change Control Board processes and track metrics.
• Update HRM website content for real-time materials.

Skills

MS Office Proficiency

Communication

Collaboration

Independent delivery

Documentation

Website design

User experience research

Veeva Vaults

Education

BS/BA in Biology, Health Sciences/Policy, IS, HCI, or related

Tools

Veeva Vaults

MS Office

Website design tools

Job description

Job Description

This role will work within Global Regulatory Affairs in the Health Registration Management (HRM) Business Process Operations group to help with the continued transition and daily business operations of HRM and Veeva Registrations. The role will support our business system global userbase and release of marketed and clinical product, compliance reporting, and submissions to the HA. This role will be involved in creating, updating, and implementing process documentation, training materials, education resources, reporting and metrics, and data governance. This role will provide direct support to collaboration teams and workshop facilitators to enable capture of all future requirements needed for successful continued support of evolving business needs and keeping pace with regulatory requirements. The objective of this role will be to ensure a smooth transition for our users to the system platform by providing support cross functionally. The role will also support lifecycle management, including change control process enablement.

Responsibilities/Deliverables

• Transition and maintain current process documentation- facilitates updates Business Execution Resources and supports creation of new resources when applicable
• Training and education support- Transition of training content and continued support and evolution
• Considers and takes in feedback from users for enhancements to training and helps implement as applicable and track changes; supports roll out of updates to end user community and provides support with maintenance of training with GLD where needed
• Change Management Support-Creation of global HRM communications content, multi-modality delivery expertise
• Process support & requirements gathering- Works with SME's on requests to ensure requirements are documented and can be delivered in a timely manner
• Change Control Board support-Supports SME's to raise changes through established processes, tracking metrics and supporting CCB meetings
• Update of HRM website contents- Maintaining the website to allow for delivery of real-time topical focused materials that allow users to consume via the website or through chatbots

Preferred Experience and Skills :

• Proficient in MS Office products (Word, Excel, PowerPoint, Teams)
• Excellent written and verbal communications and attention to detail
• Interpersonal skills and ability to collaborate with others
• Able to work independently to deliver objectives for the team
• Documentation experience
• Proficiency in website design and development
• Ability to optimize user experience through research and design
• Proficient in Veeva Vaults- Specifically Veeva Registrations

Required Education:

• BS/BA in Biology, Health Sciences/Policy, Information Systems, Human Computer Interaction, or related disciplines.

Required Skills:

• Change Controls
• Change Management
• Documentation Preparation
• Employee Training Programs
• Meeting Facilitation
• Process Implementations
• Regulatory Communications
• Regulatory Processes
• Regulatory Reporting

Preferred Skills:

• Business Systems
• Regulatory Applications
• Results-Oriented

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.

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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The salary range for this role is $71,900.00 -