Full-Time

Senior Specialist

Regulatory Affairs, Advertising and Promotion

Confirmed live in the last 24 hours

Baxter International

Baxter International

10,001+ employees

Provides essential medical products and services

Compensation Overview

$80k - $110k/yr

Senior

No H1B Sponsorship

Highland Park, IL, USA

Hybrid

Minimum number of days a week onsite required.

Category
Risk & Compliance
Legal & Compliance
Required Skills
Tableau
Excel/Numbers/Sheets
Requirements
  • Bachelor’s degree or country equivalent required.
  • 3+ years of pharmaceutical industry experience preferred; minimum 1 year of regulatory experience preferred or IT concentration in life sciences, technical/engineering or related field.
  • Understanding of Veeva software (i.e., PromoMats or RIM) design, Zinc software design, or similar system design.
  • Understanding of Tableau software design.
  • Strong written and verbal communication skills, ability to organize, prioritize and meet deadlines.
  • Strong analytical skills, including digital competency.
  • Strong technical systems skills (i.e. databases, XML and Microsoft Office 365 including SharePoint, Power Automate and Excel).
  • Proofreading and editing skills.
  • Ability to contribute to multiple projects from a regulatory affairs perspective.
  • Ability to multitask and problem solve.
Responsibilities
  • 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).
Desired Qualifications
  • Knowledge of regulations for FDA submission preferred.
  • 3+ years of pharmaceutical industry experience preferred; minimum 1 year of regulatory experience preferred.

Baxter International Inc. provides a wide range of medical products and services essential for healthcare. The company operates in several areas, including critical care, hospital care, nutritional care, renal care, and surgical care. Baxter's products are used in various settings, from emergency rooms to home healthcare, helping to meet the needs of patients and healthcare professionals globally. The company develops, manufactures, and distributes medical devices, pharmaceuticals, and biotechnology products, generating revenue through sales to healthcare providers and institutions. A recent acquisition of Hillrom has enhanced Baxter's ability to offer comprehensive healthcare solutions. The company's goal is to improve care outcomes and increase access to healthcare through continuous innovation and a focus on patient needs.

Company Size

10,001+

Company Stage

IPO

Headquarters

Deerfield, Illinois

Founded

1931

Simplify Jobs

Simplify's Take

What believers are saying

  • Needle-free injection technology could enhance accessibility of Baxter's pharmaceutical products.
  • Investment in Medically Home aligns with the trend towards decentralized healthcare.
  • Partnership with Ayogo Health could improve patient adherence and outcomes in home dialysis.

What critics are saying

  • Needle-free technology may disrupt traditional injection-based therapies, affecting Baxter's market share.
  • Home-based healthcare solutions may require adaptation of Baxter's hospital-focused model.
  • Shift towards digital health solutions may necessitate significant investment in technology.

What makes Baxter International unique

  • Baxter's acquisition of Hillrom enhances its comprehensive healthcare solutions portfolio.
  • Partnership with Ayogo Health integrates behavioral science into renal care solutions.
  • Strategic investment in Medically Home positions Baxter in the hospital-at-home market.

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Benefits

Health Insurance

Dental Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Parental Leave

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Commuter Benefits

Mental Health Support

Company News

TechCrunch
Mar 31st, 2022
Novaxs Biotech Raises $1.5M To Make Injection Therapy Needle-Free

A startup spawned from a lab at the University of California, Berkeley has won investor support to work on its patented needle-free injector, which it hopes can make therapies that traditionally require daily self-administered medicines less painful. NovaXS Biotech, founded by 21-year-old Berkeley researcher Alina Su in 2020, recently closed a $1.5 million seed round []

PR Newswire
Jan 10th, 2022
Medically Home Announces a $110 Million Strategic Investment Led by Baxter International Inc., Global Medical Response and Cardinal Health to Advance Leadership in Hospital-Level Patient Care at Home

/PRNewswire/ -- Medically Home today announced a new, $110 million round of funding from strategic investors including Baxter International Inc., Global...

FreightWaves
Sep 12th, 2020
Canfor, 4 others named FourKites Golden Kite Award winners

Five companies have been named FourKites Golden Kite Award winners for their successful integration of, and results from, using FourKites technology to improve customer service and operations.

s29755.pcdn.co
Sep 12th, 2020
Canfor, 4 others named FourKites Golden Kite Award winners

Five companies have been named FourKites Golden Kite Award winners for their successful integration of, and results from, using FourKites technology to improve customer service and operations.

CanHealth
Aug 5th, 2020
Baxter and Ayogo partner on home dialysis

DEERFIELD, Ill. and VANCOUVER, BC – Baxter International Inc., a global innovator in renal care, and Ayogo Health Inc., a behavioral science-based digital health company, announced the expansion of their partnership to support the needs of patients with kidney disease through digital health solutions. Ayogo is