Associate Specialist, Regulatory Affairs - Hybrid

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.

This candidate should excel at consistent collaboration enabling cross functional critical business partnerships ensuring compliance to align tasks and move projects forward. This role will further support and ensure continuity and consistency for additional Veeva implementation phases, including content planning, document management and publishing.

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:

Preferred Skills:

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The salary range for this role is

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

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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.

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