Medical Affairs Specialist

Medical Affairs Specialist

This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week

At West, we're a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future? There's no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families. We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

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. This role plays a pivotal role in supporting clinical consultation and medical affairs activities within the development of medical products. This role bridges the gap between clinical practice and research, ensuring that medical device development are not only scientifically sound but also practically relevant and patient-focused. The incumbent will collaborate with clinical teams, regulatory bodies and cross functional departments to support the smooth execution of risk evaluation, documentation and safety assessments. The role will also support clinical consultation and medical affairs by ensuring that clinical regulatory technical documentation, and testing validation are aligned with clinical work flow, real-world clinical practices and patient needs, ultimately enhancing the development of safe and effective medical products.

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 of 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
• Strong experience in of global regulatory (drug or device or combination products) and GxP guidelines.
• Understanding and experience with the use and development of medical devices and combination products.

Preferred Knowledge, Skills and Abilities

• Hospital experience and working in the pharmaceutical/CRO industry preferred.
• Demonstrated ability to think critically and analytically
• Ability to work as part of a team as well as independently
• 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

Travel Requirements

• 10%: Up to 26 business days per year

Physical Requirements

• Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.

Additional Requirements

• Occasional on-call work required

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.