Rahway, NJ, 07065, USA
3 days ago
Combination Device Development Project Manager
Job Description Insight Global is seeking a Combination Device Development Project Manager to join a pharmaceutical client's Device Product & Process Development (DPPD) Team. This team designs, develops, and commercializes novel biologic/drug/vaccine-device-enabled combination products to achieve safe and effective delivery to their intended site of action. The DPPD Team manages the development of the device constituent of our company's pipeline of combination products across a variety of therapy areas and routes of administration including inhalation, implantation, and injection. Duties: * Collaborate with cross functional team members and support drug-device combination product program technical and engineering leads to develop and maintain project timelines. * Track project milestones, deliverables, and risks; prepare reports/dashboards/risk register that summarize key progress and issues on development programs across different device project teams, including preparation and presentation of routine updates to management. * Support teams through the effective execution of management-approved strategic plans for assigned projects; this includes ensuring key milestones are tracked, risk management plans are fully developed, deliverables/decisions are agreed upon and adhered to, communications within and external to the team are clear and effective when significant program deviations are encountered. * Support teams through scenario planning to evaluate the pros and cons of proposed scenarios, identify constraints and trade-offs between different scenarios, and provide new/updated timelines as needed. * Ensure project data are accurately reported in databases and understood by development team members and governance forums, including information used to derive costs, schedule, resources, and any other data pertinent to creation and management of project plans. * Ensure that team meetings have structure and clear purposes and goals; facilitate meetings, issue meeting minutes and clearly communicate decisions and action items to team members and relevant parties outside of the team. * Collaborate with project managers of the Development and Commercial Team and other working group and sub-team leads to integrate their timelines with the device development timeline. * Provide input/direction on program timeline needs to internal and external sites and integrate timelines from suppliers and sites into the device development timeline. * Develop and manage material demand schedule and interface with external partners & sites to ensure the availability of materials needed to support product development and commercial capability building activities. This is a hybrid role, required 2-3 days a week on-site in either Rahway, NJ or West Point, PA. We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .     To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ . Skills and Requirements BS/MS with 5+ years of industry experience supporting the development of combination devices Understand the medical device and drug development process well and be good at data analysis/summary. Demonstrated experience/skills on risk identification, analysis and mitigation. Ability to Track project milestones, deliverables, and risks; prepare reports/dashboards/risk register including preparation and presentation of routine updates to management. Ability to develop and manage material demand schedule and interface with external partners & sites to ensure the availability of materials needed to support product development and commercial capability-building activities. Experience working with vendors/suppliers and ability to understand their impact on project timelines Experience supporting injectable product lines Experience with medical device design controls and risk management is a plus. PMP Certification 10+ years of experience supporting similar projects Advanced education degree in a related field null We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.
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