Medical Affairs Specialist

Description

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.

• Inclusive & Collaborative Culture: A global workforce that values diversity, equity, and inclusion—where all voices are heard and respected in a supportive environment.
• Generous Paid Time Off (PTO):
  Flexible vacation, personal, and holiday leave ensures employees can maintain a healthy work‑life balance and recharge effectively.
• Recognition & Rewards:
  Performance‑based bonuses, service recognition, and employee appreciation initiatives celebrate dedication and impact.

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 workflow, real‑world clinical practices and patient needs, ultimately enhancing the development of safe and effective medical products.

• 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…