Medical Affairs Specialist

Job Summary

The Medical Affairs Specialist at West is a global function dedicated to supporting the company's clinical activities and aligning with strategic goals to maintain high standards for patient safety and support regulatory obligations. The Specialist role plays a crucial role in identifying the clinical value proposition for innovative concepts. These activities demonstrate the company's commitment to containing and delivering injectable therapies that improve the health of patients worldwide.

Essential Duties and Responsibilities

• Act as the primary liaison between clinical experts and cross functional teams (quality, operations, engineering, regulatory etc.), facilitating the exchange of clinical insights and literature research findings.
• Support the Medical Affairs team by providing detailed clinical insights and ensuring regulatory documentation address the practical needs of healthcare providers and patients.
• Assist in developing and executing Clinical Evaluation Strategies that integrate current clinical practices and methodologies.
• Contribute to the clinical literature search by providing insights into relevant clinical trends and findings.
• Collaborate with clinical teams to conduct formative and summative usability studies, supporting products needs for both clinicians and patients. Review and interpret usability study results from a clinical perspective, providing guidance on usability improvements.
• Participate in risk management activities, including dFMEA, uFMEA, pFMEA, URRA, and the development of risk management plans. Evaluate potential hazards and harms within clinical contexts to support robust risk mitigation strategies.
• Support the creation of clinical documentation to reflect up-to-date clinical practices and standards.
• Facilitate communication between the Medical Affairs team and other stakeholders, so that clinical insights are disseminated and integrated effectively across projects.
• Completes required administrative tasks within the specified timeframes.
• Performs related duties as assigned.

Basic Qualification

• PharmD, MD, Or RN degree required
• Minimum of 3 years clinical and/or hospital experience
• Minimum 5+ years of relevant medical experience

Work Experience

• Strong experience in global regulatory (drug or device or combination products) and GxP guidelines.
• Must have excellent project management skills and excellent written and verbal communication skills
• Prior supervisory experience preferred and quality improvement or educational experience

Preferred Knowledge, Skills and Abilities

• Hospital experience and working in the pharmaceutical/CRO industry preferred.
• Demonstrated ability to think critically and analytically
• Aptitude for reviewing and understanding clinical trials protocol
• Ability to understand and interpret clinical literature (via medical journals, and resources like Medline, PubMed, etc.)
• Good knowledge of document management systems and relevant applications.
• Strong understanding of clinical practices and the ability to translate clinical needs into research objectives.
• Skill in managing consultations and clinical affairs activities, ensuring timely and effective execution.
• Ability to assess and integrate clinical data, research findings, and usability assessments into actionable strategies.
• Strong ability to work in multi-functional teams, bridging clinical practice and research.

License and Certifications

• Clear and active PA medical licensure required

Physical Requirements

• Occasional on-call work required