Job Description

Job Description Reporting to the Director of Combination Product Development, the Associate Director - Device Development is the technical expert in the field of combination products & drug delivery devices who can effectively navigate and balance complex engineering, regulatory, quality and commercial needs while developing the best product for the user and patient. You are responsible for the creation and management of design history files and technical dossiers for combination and device projects for new and existing products. 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 and 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. Support the vision for the Device Development & Technology function: Support and implement a vision with appropriate strategies that supports the OPDC objectives and aligns with the business and OPCJ/OPDC/MDD development programs. Work with the Director of Device Development and other functions including Packaging, Supply Chain, Clinical Supplies Operations, Quality Control, and Quality Management to support strategies for product and process improvements. Support the development of flexible and compliant product development process. Develop and support the strategic activities of the department: Support and implement appropriate filing strategies working with OPCJ, OPDC, MDD and OAPI departments to support registration of all new products and life-cycle management products. Initiate and manage the development and implementation of policies, procedures, and standards for the Device Technology department. Evaluate and recommend strategic directions for new and innovative delivery device technologies to support new and life-cycle management projects. Develop and perform the tactical activities: Ensure efficient transfer of products and on-going product support all products to CMO's from device perspective. Develop and maintain departmental knowledge, experience, and expertise in state-of-the-art devices for pharmaceutical products. Assure adherence to latest worldwide regulatory rules and guidance concerning devices and work to develop device risk mitigation. Create, maintain, and update device related documents required for regulatory filings and compliance Facilitate studies as required. Write protocols, reports, specifications, procedures, change control requests, technical assessments, etc. Program management of Device projects: Develop project plans and corresponding project managements tools to support the execution of all projects Manage cross functional teams (including 3rd party resources). Execute Human Factors Engineering & Usability activities. Qualifications/ Required Knowledge/ Experience and Skills: This position requires 6-10 years of applicable experience in the pharmaceutical, biotechnology or medical device industries. Primary expertise should be demonstrated in engineering, device regulatory, device quality systems (cfr 820, ISO 13485), human factors engineering principals, risk management for medical devices (ISO 14971), etc. You should demonstrate strong technical writing and presentation skills and be able to translate technical information to non-technical audiences. Demonstrated leadership skills especially the management of high-visibility project teams. Demonstrated knowledge of parenteral delivery devices (syringes, self/ or auto-injectors), etc. 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 on multiple projects. Excellent written and verbal communication skills with demonstrated ability to establish and maintain effective communications internally and with external manufacturing partners. Competency in use of business and project management computer software (such as MSProject and MSOffice). Travel (approximately 20 - 25%) Educational Qualifications Bachelor's degree in a related Engineering discipline (Mechanical, Electrical, Biomedical, etc.) Masters or advanced degree preferred Competencies Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business. Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders. Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. Respectful Collaboration - Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. Empowered Development - Play an active role in professional development as a business imperative. Come discover more about Otsuka and our benefit offerings; . Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer . All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic . If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability . You can request reasonable accommodations by contacting Accommodation Request . Statement Regarding Job Recruiting Fraud Scams At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., a nd Otsuka Precision Health, Inc. (Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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