(Junior) Expert (m/w/d) Medical Systems Products at Fresenius Medical Care

Bad Homburg vor der Höhe, Hesse, Germany

Fresenius Medical Care Logo
Not SpecifiedCompensation
Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level
Full TimeJob Type
UnknownVisa
Medizintechnik, Pharmazeutika, GesundheitswesenIndustries

Requirements

  • Successfully completed university degree in Medicine, Pharmacy, or a related discipline
  • At least 3 years of professional experience in the pharmaceutical or medical technology industry, patient care, or research institutions (desirable)
  • Knowledge of medicinal products and relevant regulations
  • Experience in creating medical and scientific texts as well as coordinating and compiling contributions
  • Experience in systematic research of medical and scientific databases
  • Familiarity with products and topics in the field of dialysis and nephrology
  • Interactive and interdisciplinary working style, pronounced communication skills, and intercultural competence
  • Very good English skills in spoken and written form; German is a plus
  • Sound IT skills, especially in MS Office

Responsibilities

  • Creation and updating of Drug Dossiers, especially the clinical part
  • Responding to approval-relevant medical and pharmacological questions from authorities
  • Participation in development projects for medicinal products
  • Creation of clinical evaluations and reports for medical devices in collaboration with the Therapy Field Manager
  • Support of the Therapy Field Manager during audits, especially regarding relevant documentation
  • Participation in risk management, including creation and maintenance of product-specific risk management documents
  • Participation in interdisciplinary teams to represent medical-regulatory aspects
  • Development of medical evaluations on product development issues and definition of new medical evidence in collaboration with the Therapy Field Manager
  • Approval of medically relevant product changes in collaboration with the Therapy Field Manager
  • Planning and support of medical-scientific activities in collaboration with the Therapy Field Manager and Clinical Research
  • Evaluation of relevant literature as part of the literature vigilance process
  • Contributions to strategy and process topics within the department

Skills

Drug Dossiers
Klinische Bewertungen
Risikomanagement
Regulatorische Compliance
Medizinprodukte
Literaturrecherche
Pharmakologie
Arzneimittelentwicklung
Audits
Wissenschaftliche Texte

Fresenius Medical Care

Provides dialysis and renal healthcare services

About Fresenius Medical Care

Fresenius Medical Care North America focuses on delivering high-quality healthcare services to individuals with kidney and other chronic conditions. The company operates a vast network of dialysis centers and outpatient labs for cardiac and vascular care, ensuring coordinated treatment for many patients across the continent. It stands out as the largest fully integrated renal company, providing not only dialysis services but also specialty pharmacy and laboratory services. Additionally, Fresenius manufactures and distributes a wide range of dialysis equipment, disposable products, and renal pharmaceuticals. The goal of Fresenius Medical Care is to enhance the quality of life for patients with chronic illnesses by providing comprehensive and accessible healthcare solutions.

Waltham, MassachusettsHeadquarters
1996Year Founded
$39.1MTotal Funding
LATE_VCCompany Stage
Biotechnology, HealthcareIndustries
11-50Employees

Benefits

Professional Development Budget
Conference Attendance Budget
Flexible Work Hours

Risks

Increased competition from telehealth solutions like Philips' eCareManager 4.1.
Rising mental health challenges may impact FMCNA's employee productivity.
Virtual reality education may face adoption and accessibility challenges in rural areas.

Differentiation

FMCNA is the world's largest fully integrated renal company.
FMCNA offers a comprehensive line of dialysis equipment and renal pharmaceuticals.
FMCNA provides coordinated healthcare services at pivotal care points for chronic conditions.

Upsides

Telehealth market growth supports FMCNA's remote patient monitoring services.
Home dialysis market expansion aligns with FMCNA's patient-centric care approach.
AI integration enhances FMCNA's predictive analytics and personalized medicine capabilities.

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