Senior Specialist, Regulatory Affairs (Advertising and Promotion) at Baxter
Deerfield, IL 60015, USA -
Full Time


Start Date

Immediate

Expiry Date

15 Sep, 25

Salary

80000.0

Posted On

15 Jun, 25

Experience

1 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Good communication skills

Industry

Human Resources/HR

Description

THIS IS WHERE YOU SAVE AND SUSTAIN LIVES

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission.

Responsibilities

YOUR ROLE AT BAXTER

The Senior Specialist resides within the Global Regulatory Affairs, Advertising and Promotions Group. This group owns the global Advertising and Promotions (Ad Prom) process, and the system that enables the process (Veeva PromoMats). This role is responsible for creating the FDA submission package for promotional material in Veeva PromoMats, and also for general system administration and configuration for Veeva PromoMats. An ideal candidate will have back-end experience with Ad Prom systems and software, or have general Information Technology or Systems Administration experience within a life science or other technical environment.

WHAT YOU’LL BE DOING

  • Under general supervision, responsible for Veeva PromoMats, Tableau , and regulatory documents for FDA submission.
  • Perform Veeva PromoMats system updates (i.e., workflows, configurations, lifecycle management, XML management, spreadsheets, templates, etc.).
  • Identify areas for improvement/modification.
  • Compile regulatory documents for FDA submission (eCTD experience preferred). Which includes: tracking of status and progress of regulatory documentation, reviewing, editing and proofreading regulatory documentation, participating as an active team member of project teams as required, maintaining regulatory files in a format consistent with requirements as well as staying aware of regulatory requirements.
  • Develop training material and liaise with cross function teams.
  • Understand internal global process (i.e. Advertising and Promotion process).|
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