- Reckitt (Wilson, NC)
- …activities in the compliance programme under your remit, working closely with the technical project manager to ensure tasks are completed by you and your team ... schedule + Accountable for the delivery and execution of project work of your team + Accountable for the...FDA and ICH guidelines + Proficient in Microsoft Project , Word, Excel and PowerPoint Preferred: + Experience with… more
- United Therapeutics (Research Triangle Park, NC)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... holidays) on a rotational basis + Participation in Change Manager Role on a rotational basis + Excellent written...medical industry compliance regimes and controls a plus (ie FDA 21CFR 11, HIPAA/HITECH) + Present ideas and information… more
- Fujifilm (Raleigh, NC)
- …the assistance of technical support, as directed by the Area Service Manager . **Company Overview** At FUJIFILM Healthcare Americas Corporation, we're on a mission ... Performs other duties as assigned by the Area Service Manager . + Comply with all applicable US Food and...with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard… more
- United Therapeutics (Research Triangle Park, NC)
- …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... inception (Phase 1-3) to successful product approval by the FDA and other regulatory agencies. + Design and review...to maintain awareness of research activities and represent a project and/or the company + Participate in cross-functional teams,… more
- Dentsply Sirona (Charlotte, NC)
- …- Certified Information Systems Security Professional + CISM - Certified Information Security Manager + GIAC certifications (eg, GCIA, GCIH, GNFA) + OSCP - Offensive ... with ISO/IEC 27001 and incident reporting requirements under HIPAA, GDPR, SEC, or FDA 524B + Ability to lead effectively under pressure and during high-impact cyber… more
- Reynolds American (Winston Salem, NC)
- …countries with over 55,000 employees. The GGP prepares you for a Lead Manager role within one year, with international career opportunities across BAT's footprint. ... strategies via the internship and global graduate programs. + Deliver assigned project at a high-level through collaboration and self-leadership. + Investigate and… more
- Cardinal Health (Raleigh, NC)
- …systems and contributes to reports and presentations for clients. May serve as a project manager for smaller projects and ensure that team members achieve ... are being submitted. Manages multiple work assignments in order to meet project timelines. + Drafts submissions for products, ensuring that all relevant product… more
- Insight Global (Holly Springs, NC)
- …integration and enforced workflows for a CDMO facility. * Attend regularly scheduled project status meetings with FDBN DSM MES Team. * Provide design review and ... Execution o Electronic Batch Record (EBR) o Quality Review Manager (QRM) o Weigh & Dispense * Coordinate with...(QRM) o Weigh & Dispense * Coordinate with various project workstreams including Automation, CSV, CQV, Utilities, Process Engineering,… more
- Fujifilm (Raleigh, NC)
- …with the Product Support Specialist (PSS) or the Imaging System Project Manager (ISPM) to address incompatibilities/concerns. + Makes recommendations ... changes. + Interfaces with internal and external customers in support of project coordination and to address any challenges/discrepancies that may arise during the… more
- Fujifilm (Raleigh, NC)
- …Positive customer surveys, documentation accuracy and consistency, timely case and project completion, and finishing the assigned trainings are standard expectations ... level of success with yearly goals provided by your manager and metrics defined on a team level. +...with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard… more
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