Manager, Medical Affairs – Clinical Nutrition
Fresenius Kabi USA
full-time
Posted on:
Location Type: Hybrid
Location: Lake Zurich • Illinois • United States
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Salary
💰 $140,000 - $155,000 per year
About the role
- Serve as the Medical reviewer at the Medical-Legal-Regulatory (MLR) review team for the US Clinical Nutrition team.
- Lead the management and oversight of Medical Information and medical affairs including new product launches for Clinical Nutrition team.
- Collaborate with the other medical affairs team members to provide expertise and support on a broad range of activities including medical communication, medical training, congress strategy and execution, and data generation and clinical education across Clinical Nutrition portfolio.
- Develop, maintain, and update standard response letters (SRLs), FAQs, and other medical information resources to ensure consistency and compliance with regulatory requirements.
- Collaborate with cross-functional teams to review product labeling, ensuring alignment with scientific evidence, regulatory standards, and therapeutic needs.
- Provide medical expertise to commercial, regulatory, and clinical teams for the launch and life-cycle management of clinical nutrition products.
- Prepare medical content for presentations, educational materials, and advisory boards as needed.
- Provide operational support to the US Clinical Nutrition Medical Affairs team including managing team projects, timelines, and budget, contracting, and vendor management.
- Collaborate with the Global Medical, Clinical, and Regulatory Affairs in the management of US-based clinical trials including regulatory requests and PMRs.
Requirements
- Advanced qualification as a Registered Dietitian (RD/RDN) or a Master’s degree in a relevant clinical discipline (nutrition)
- 5+ years of overall experience
- 3+ years of experience in Medical Affairs
- 2+ years of experience as Medical Reviewer in Medical-Legal-Regulatory review (MLR)
- Demonstrated knowledge in nutrition care is strongly preferred
- Demonstrated skill in interpreting and writing scientific documents.
- Knowledge of pharmaceutical product development and clinical trial design processes
- Knowledge of US Healthcare system including reimbursement and access to pharmaceuticals, medical food, and supplemental therapies
- Excellent communication (both written and verbal) and presentation skills – capacity to translate complex clinical information in concise verbal and written description.
Benefits
- 401(k) plan with company contributions
- paid vacation
- holiday and personal days
- employee assistance program
- health benefits to include medical, prescription drug, dental and vision coverage
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Medical AffairsMedical ReviewClinical NutritionScientific Document WritingClinical Trial DesignNutrition CareRegulatory ComplianceProduct LabelingData GenerationMedical Communication
Soft Skills
CommunicationPresentationCollaborationProject ManagementLeadershipInterpersonal SkillsOrganizational SkillsAnalytical SkillsProblem SolvingTeam Management
Certifications
Registered Dietitian (RD/RDN)Master’s Degree in Nutrition