Global Medical Affairs Specialist

Kaztronix; Radnor (Delaware County); Híbrido; USD 110 000 - 160 000; Tempo integral

Resumo da oferta

Kaztronix seeks a Medical Affairs Specialist to support clinical activities and align with regulatory obligations, developing clinical value propositions for injectable therapies and ensuring patient safety.

The role bridges clinical practice and research, collaborating with regulatory bodies and cross-functional teams to ensure documentation and testing validation align with real-world clinical workflows and patient needs.

Qualificações

• Strong knowledge of global regulatory (drug, device or combination products) requirements.
• Experience with GxP guidelines and quality systems.
• Excellent project management and communication skills.
• Ability to review and translate clinical literature for research objectives.
• Experience in cross-functional teamwork and coordinating clinical affairs.

Responsabilidades

• Act as the primary liaison between clinical experts and cross-functional teams.
• Support regulatory documentation addressing practical needs of providers and patients.
• Develop and execute Clinical Evaluation Strategies.
• Contribute to clinical literature searching and trend analysis.
• Collaborate on usability studies and interpret results from a clinical perspective.
• Participate in risk management activities and develop risk mitigation plans.

Conhecimentos

Global regulatory knowledge

GxP guidelines

Project management

Written and verbal communication

Cross-functional collaboration

Clinical literature interpretation

Team leadership or supervision

Formação académica

PharmD/MD/RN degree

Clinical hospital experience

Descrição da oferta de emprego

Kaztronix seeks a Medical Affairs Specialist to support clinical activities and align with regulatory obligations, developing clinical value propositions for injectable therapies and ensuring patient safety.

The role bridges clinical practice and research, collaborating with regulatory bodies and cross-functional teams to ensure documentation and testing validation align with real-world clinical workflows and patient needs.