Tredyffrin Township, Pennsylvania, United States · Hybrid
Senior
This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week Who We Are: At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the cente…
Skills: Clinical Evaluation Strategies, Risk Management, Usability Studies, Medical Literature Research, Project Management
Uwchlan Township, Pennsylvania, United States · Hybrid
Senior
This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week. No relocation or visa sponsorship is provided for this opportunity. Who We Are: At West, we’re a dedicated team that is conne…
Skills: Financial modeling, Commercial operations, Contract management, Data analysis, Excel
Uwchlan Township, Pennsylvania, United States · Hybrid
Senior
This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week. No relocation or visa sponsorship is provided for this opportunity. Who We Are: At West, we’re a dedicated team that is conne…
Skills: Financial modeling, Contract management, Data analysis, Excel, SAP HANA
Senior Manager SAP QM, Functional Design & Architect
Uwchlan Township, Pennsylvania, United States · Hybrid
Senior+
This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week No relocation is provided for this opportunity Who We Are: At West, we’re a dedicated team that is connected by a purpose to i…
Skills: SAP QM, Functional design, SAP S/4HANA, Quality management, Process standardization
Stolberg, North Rhine-Westphalia, Germany · On-site
Entry level
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 supply…
Eschweiler, North Rhine-Westphalia, Germany · Hybrid
$63k–$80k/yr
Mid level
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 supply…
Skills: Occupational Health And Safety, Risk Analysis, Accident Investigation, Root Cause Analysis, Safety Engineering
Eschweiler, North Rhine-Westphalia, Germany · On-site
$63k–$80k/yr
Mid level
Wir bei West sind ein engagiertes Team, das durch das Ziel verbunden ist, das Leben von Patienten zu verbessern, die seit mehr als einem Jahrhundert im Mittelpunkt unseres Unternehmens stehen. Unsere Geschichte begann, a…
Skills: Occupational Health and Safety, Risk Analysis, Root Cause Analysis, Environmental Protection Law, ISO 14001
Stolberg, North Rhine-Westphalia, Germany · On-site
Entry level
Wir bei West sind ein engagiertes Team, das durch das Ziel verbunden ist, das Leben von Patienten zu verbessern, die seit mehr als einem Jahrhundert im Mittelpunkt unseres Unternehmens stehen. Unsere Geschichte begann, a…
Skills: Machine operation, Raw material handling, In-process control, Quality control, Packaging
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 supply…
Skills: Sales Analysis, Sales Planning, Forecasting, Data Visualization, Tableau
Piatt Township, Pennsylvania, United States · On-site
Senior+
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 supply…
Skills: Procurement, Production Planning, Warehouse Management, S&OP, Inventory Management
Loyalsock Township, Pennsylvania, United States · On-site
Entry level
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 supply…
Skills: Inspection, Packaging, Labeling, Documentation, Quality control
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 supply…
Skills: Production leadership, Manufacturing, Plastics injection molding, Team supervision, Process improvement
Loyalsock Township, Pennsylvania, United States · On-site
Mid level
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 supply…
Skills: Root cause analysis, Technical investigation, Quality assurance, Regulatory compliance, ISO 13485
Uwchlan Township, Pennsylvania, United States · Hybrid
Mid level
This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week. No relocation is provided for this opportunity. At West, we’re a dedicated team that is connected by a purpose to improve pat…
Skills: Employee relations, Performance management, Onboarding, Recruitment, Employment law compliance
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 supply…
Skills: Material handling, Logistics support, Inventory management, ERP system, First in first out
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 supply…
Skills: Material handling, Inventory management, ERP system, Forklift operation, Logistics support
Eschweiler, North Rhine-Westphalia, Germany · On-site
$45k–$58k/yr
Mid level
Wir bei West sind ein engagiertes Team, das durch das Ziel verbunden ist, das Leben von Patienten zu verbessern, die seit mehr als einem Jahrhundert im Mittelpunkt unseres Unternehmens stehen. Unsere Geschichte begann, a…
Skills: Rubber compounding, Laboratory mixing, Raw material management, GMP compliance, SAP
Williamsport, Pennsylvania, United States · On-site
Entry level
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 supply…
Eschweiler, North Rhine-Westphalia, Germany · On-site
$45k–$58k/yr
Mid level
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 supply…
Skills: Rubber compounding, Laboratory mixing, Raw material management, GMP principles, Sample production
Uwchlan Township, Pennsylvania, United States · Hybrid
Senior+
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 supply…
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Full-time
postgraduate degree
Paid Time Off, Flexible Vacation, Personal Leave, Holiday Leave, Performance-based Bonuses, Service Recognition
Posted 9d ago
~40 hrs/week
Responsibilities
The Medical Affairs Specialist acts as a liaison between clinical experts and cross-functional teams to align medical product development with clinical practice and patient needs. They support risk management activities, usability studies, and the creation of clinical regulatory technical documentation.
Requirements
Requires a PharmD, MD, or RN degree with at least 5 years of relevant medical experience and 3 years of clinical or hospital experience. Candidates must hold an active PA medical licensure and possess strong knowledge of global regulatory guidelines and GxP.
Full job description
This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week
Who We Are:
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.
What We Offer
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.
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.
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. #LI-NJ1 #LI-Hybrid
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. If you have a special need that requires accommodation in order to apply to West, please send an email to [email protected]. Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening.
Related keywords
Medical AffairsPharmDMDRNGxPdFMEAuFMEApFMEAURRAMedlinePubMedClinical TrialsCombination ProductsMedical DevicesRegulatory AffairsPatient Safety
West Pharmaceutical Services, Inc. is a leading provider of innovative, high-quality injectable solutions and services. As a trusted partner to established and emerging drug developers, West helps ensure the safe, effective containment and delivery of life-saving and life-enhancing medicines for patients. With 10,000 team members across 50 sites worldwide, West helps support our customers by delivering billions of components and devices each year.
West is traded on the New York Stock Exchange (NYSE: WST) and is included on the Standard & Poor's 500 index.
Offices: West Pharmaceutical Services, Inc., 530 Herman O. West Drive, Exton, PA 19341, US
Pharmaceutical Packaging Systems and Pharmaceutical Delivery SystemsMobile AppsHealth CareAppsPackaging ServicesBiotechnologyIndustrialPharmaceuticalManufacturing
West Pharmaceutical Services, Inc. is a leading provider of innovative, high-quality injectable solutions and services. As a trusted partner to established and emerging drug developers, West helps ensure the safe, effective containment and delivery of life-saving and life-enhancing medicines for patients. With 10,000 team members across 50 sites worldwide, West helps support our customers by delivering billions of components and devices each year.
West is traded on the New York Stock Exchange (NYSE: WST) and is included on the Standard & Poor's 500 index.
Offices: West Pharmaceutical Services, Inc., 530 Herman O. West Drive, Exton, PA 19341, US
Pharmaceutical Packaging Systems and Pharmaceutical Delivery SystemsMobile AppsHealth CareAppsPackaging ServicesBiotechnologyIndustrialPharmaceuticalManufacturing