Location: Deerfield, Illinois
Baxter has been at the forefront of healthcare innovation for nearly a century, delivering life-saving medical devices, pharmaceuticals, and therapies that improve patient outcomes worldwide. With a strong mission to save and sustain lives, Baxter is present in hospitals, clinics, and homes across the globe.
We are seeking a Medical Affairs Specialist to join our dynamic team, contributing to regulatory and clinical excellence across Baxter’s pharmaceutical portfolio.
Medical Affairs Specialist Job Summary
As a Medical Affairs Specialist, you will play a critical role in providing clinical expertise, preparing regulatory documents, and ensuring compliance with global healthcare standards. You will collaborate with cross-functional teams, including Medical Affairs, Clinical Development, Quality, Regulatory Affairs, and Patient Safety, to support Baxter’s mission of improving patient care.
✅ Key Responsibilities
- Provide clinical expertise on Baxter pharmaceuticals, including product use and risk management.
- Develop and review critical regulatory documents:
- PBRER (Periodic Benefit-Risk Evaluation Reports)
- PSUR (Periodic Safety Update Reports)
- CER (Clinical Evaluation Reports)
- RMP (Risk Management Plans)
- PBRER (Periodic Benefit-Risk Evaluation Reports)
- Ensure compliance with global regulatory standards.
- Analyze and support product complaint investigations.
- Summarize medical information for both clinical and non-clinical stakeholders.
- Collaborate with global teams to respond to regulatory authority inquiries.
💡 Required Qualifications
- Degree: Master in Pharmacy, PharmD, or BS Pharm.
- Experience: 3+ years of clinical experience, preferably with drug compounding.
- Strong knowledge of PSURs, PBRERs, CERs, RMPs, and risk management documentation.
- Familiarity with:
- US Pharmacy Regulations
- USP 797 & 795
- ISMP Guidelines
- US Pharmacy Regulations
- Excellent scientific writing, analytical, and problem-solving skills.
- Ability to manage multiple projects with competing priorities.
- Strong communication and interpersonal skills across cross-functional teams.
🌍 Why Join Baxter?
- Be part of a global healthcare leader with a mission to save and sustain lives.
- Work alongside talented clinicians, scientists, and regulatory experts.
- Engage in meaningful work that improves patient outcomes worldwide.
- Grow your career in a collaborative, purpose-driven environment.
⚠️ Additional Information
- Reasonable Accommodations: Baxter is committed to supporting applicants with disabilities. Learn more on our website.
- Recruitment Fraud Alert: Beware of fraudulent recruitment activities. Visit the official Baxter Recruitment Fraud Notice for details.
✨ Ready to accelerate your career at the intersection of healthcare and innovation? Apply now at click the link.