Enable America Jobs

Regulatory Operations, Contractor

Location Remote (NJ)

Requisition ID 2255

# of openings 1

Apply Now (https://phh.tbe.taleo.net/phh04/ats/careers/v2/applyRequisition?org=AMICUS&cws=37&rid=1300)

Regulatory Operations, Contractor

Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing, and delivering high-quality medicines for people living with rare metabolic diseases.

Position Summary

The Contractor, Regulatory Operations will be responsible for the successful cross-functional expansion of the Veeva Vault Regulatory Information Management (RIM) system to Amicus end users. This individual will deliver and drive end user training of document management capabilities/workflows/processes in the Veeva Vault RIM system.

This individual will also support end user questions and adoption ensuring this common platform is utilized by all Amicus users to manage Regulatory submissions documents from start-to-finish within RIM. This includes document initiation, collaboration, reviews and approvals – all managed within Vault RIM.

This individual is expected to have a business administration knowledge of RIM systems, in order to drive operational execution of Global Regulatory Affairs (GRA) activities.

Roles and Responsibilities

1. Lead the preparation and delivery of end user training for document management processes and procedures with Veeva Vault RIM as access to RIM expands to cross-functional colleagues

2. Provide end user support by resolving issues and answering questions to ensure adoption and utilization of Vault RIM as a common platform for managing Regulatory submission documents

3. Provide one-on-one support for colleagues, as needed, to demonstrate the various document management workflows in Vault RIM – including, but not limited to, document initiation, collaborative authoring, document reviews and approvals

4. Provide input, participate, and/or lead department initiatives with a focus on ongoing improvement of RIM processes and tools, developing and contributing to new regulatory processes and SOPs/GDLs and support training of key personnel, as needed

5. Manage entry and creation of various documents and data in Vault RIM, in collaboration with GRA colleagues

6. Participate in relevant submission planning meetings in order to support operational activities with Regulatory colleagues

7. Manage the updates of various document templates and metadata in Vault RIM

Requirements

Educational Requirements

• Bachelor’s or Master’s degree in a scientific discipline, regulatory affairs or equivalent required

Professional Work Experience Requirements

• 3-5 years of Regulatory Affairs Operations experience with drugs and/or biologics

Experience and Skills

• Experience using Veeva Vault Regulatory Information Management (RIM), including its document management capabilities

• Experience in working with cross-functional teams

• Expert in the use of the Microsoft Office Suite, Adobe Acrobat, SharePoint, document and registration Regulatory Information Management systems

• Working knowledge of global regulatory practices, electronic submission guidelines and submission ready document requirements

Other skills/Attributes

• Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems

• Excellent organizational, communication, and time management skills needed to manage multiple ongoing projects simultaneously

• Demonstrated alignment with Amicus Mission Focus Behaviors

• Passion for rare disease and patient focused

• Good team player

Travel

• Up to 10%

We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all. Our unique experiences, backgrounds and range of cultural perspectives enrich how we approach opportunities, pushing ideas as far and as fast as possible with patients always our top priority. Employee expertise, intelligence, and creativity drives our innovation, and our passion and commitment to excellence. Our “Three Pillars of DEI” are interwoven into our Amicus culture and expands one person, one word, and one act at a time. For our employees, these three pillars are a touchstone for inspiration, guidance, and encouragement.

Amicus is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability, sexual orientation, gender identity, protected veteran, disability status or any other characteristics protected by applicable federal, state or local law.

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