- This role is critical to streamlining Device CoE processes to ensure delivery of critical programs on time and budget while collaborating closely with stakeholders in other departments and functions
- Collaborate with stakeholders to map device program deliverables that are key to product success
- Manage and coordinate Device business and technical requirements as an input into the overall combination product planning and execution
- Manage business process alignment projects necessary to improving predictability of outcomes and deliverables
- Develop framework for tracking device program progress against deliverables identified in the business process document
- Lead the development and implementation of streamlined business processes for device development programs in the Medical Device Center of Excellence (CoE).
- Collaborate with Device Development Leaders, Program Managers and other key stakeholders (Global Product Teams, Clinical, Manufacturing, Quality, Packaging, Regulatory etc.) to map device program deliverables that are key to product success.
- Drive consistency and excellence in early, development and commercial stage programs by standardizing:
- Target Device Profiles
- Device Development Plans
- Device Schedules
- Development process stage contracts
- Development process stage exit reviews
- Integrate Medical Device CoE processes and milestones into the Pharmaceutical Sciences development framework. Ensure buy-in from key Device functions such as Development Engineering, Human Factors, Program Stewardship, Drug-Device Compatibility Testing, Regulatory, Quality etc.
- Champion the implementation of the Medical Device development process to ensure goals of process are met
- Define metrics for tracking progress on device programs in accordance with the Medical Device development process
- Identify programs for implementation and adoption of the Medical Device development process and ensure successful adoption of tools and methods by attending program kickoff and stage exit reviews
- Maintain lessons learned throughout life of business process projects to facilitate continuous improvement
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS
- Bachelor s degree and a minimum of 10 years of previous project management or leadership experience in product development in a regulated healthcare environment.
- To perform this job satisfactorily, must demonstrate analytical, problem solving, and leadership skills.
- Must have excellent oral and written communication skills and the ability to communicate in a clear and concise manner with all levels of the organization.
- Must be an expert in using MS Project, Visio or other planning tools.
- Experience with creating business process implementation plans and defining communication strategies to bring organizational change.
- Must have knowledge of principles such as GMPs, FDA/EMEA guidelines.
- Demonstrated ability to simultaneously manage multiple projects of variable complexity.
- Health care business acumen with a comprehensive understanding of the pharmaceutical industry is a minimum requirement.
- Preferred: Experience with global product launches for combination products and the associated CMC and/or medical device deliverables.
- Preferred: PMP certification & MBA.
- Travel of up to 10% may be required
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.