Senior Manager, Combination Product Development

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Otsuka Pharmaceutical Companies (U.S.)

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1001 - 5000 Mitarbeiter

💊 Pharmazie

🏥 Gesundheitswesen

🧬 Biotechnologie

Pharmaceuticals • Healthcare • Biotechnology

Die Otsuka Pharmaceutical Companies (U. S. ) sind ein bedeutender Akteur in der Pharmaindustrie und widmen sich der Entwicklung innovativer Produkte für eine bessere Gesundheit weltweit. Das Unternehmen besteht aus zwei Hauptgesellschaften: Otsuka America Pharmaceutical, Inc. (OAPI), die auf die Vermarktung von Otsuka-entdeckten und lizenzierten Produkten in Nordamerika spezialisiert ist, und Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), die sich auf die klinische Entwicklung und globale Zulassung innovativer Gesundheitslösungen, insbesondere im Bereich der Neurowissenschaften, konzentriert.

Beschreibung

• This is an Individual Contributor position, reporting to the Director of Device Development and Technology • This individual is knowledgeable in the field of combination products & drug delivery devices. • The candidate will be responsible for the management of design history files and support authoring of technical dossiers for combination product and device projects for new and existing platforms. • Additional responsibilities include facilitation of risk assessments, coordination of human factors usability studies, creation and management of product and component specifications, design control documents, engineering protocols, technical reports, and frequent presentations to project teams and management. • This position will frequently require management of outside resources as well as assigned and/or unassigned leadership of project teams in a matrix organization. • The position may involve frequent domestic and international travel up to 15-20% or as required by the project.

🎯 Anforderungen

• 5-8 years’ experience in Pharmaceuticals, Medical Devices, Biotechnology, or other related industries • In-depth understanding of device verification including functional testing, process validation/verification, quality assurance, and regulatory requirements as they pertain to and devices • Ability to work strategically and independently with internal and external groups • Demonstrated leadership skills especially the management of high-visibility project teams • Demonstrated knowledge of parenteral delivery devices (syringes, self/ or auto-injectors), etc • Self-Starter: ability to solicit & obtain time-sensitive information from various internal & external project stakeholders • Effective communicator across all levels of the organization • Able to deliver high level to detailed level status reports on programs, projects and portfolio information • Utilizes experience, presentation and influencing skills to facilitate successful team discussions and outcomes • Competency in use of business and project management computer software (such as MSProject and MSOffice) • Experienced with usability testing / user studies / human factors • Bachelor’s degree in a related Engineering discipline (Mechanical, Electrical, Biomedical, etc.) • Masters or advanced degree preferred

🏖️ Vorteile

• Comprehensive medical, dental, vision, prescription drug coverage • Company provided basic life, accidental death & dismemberment • Short-term and long-term disability insurance • Tuition reimbursement • Student loan assistance • A generous 401(k) match • Flexible time off • Paid holidays • Paid leave programs • Other company provided benefits