- Sumitomo Pharma (Boston, MA)
- …Team meetings. + Represent PV Operations on cross-functional program and project teams; support PV Medical Safety activities on cross-functional program and ... project teams, as required. + Coordinate responses to ad...and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for… more
- AbbVie (Worcester, MA)
- …Tok (https://www.tiktok.com/@abbvie) . Job Description We are seeking a result driven Manager - Automation and Controls to lead site Automation team within our ... Historian systems. + Ensure all automation systems comply with regulatory requirements ( FDA , cGMP, etc.). + Mitigates risk within functions through sound design,… more
- Fresenius Medical Center (Lawrence, MA)
- **PURPOSE AND SCOPE:** The ** Manager , HCP Marketing** is responsible for developing and executing clinically focused marketing strategies to support the education, ... relevant content that drive product understanding and adoption. + Strong project management, communication, and analytical skills + Excellent written and verbal… more
- Beth Israel Lahey Health (Burlington, MA)
- …coverage and operations support issues. + Coordinates and facilitates research project team meetings, including creating agendas and generating minutes and action ... of all aspects of clinical trials research complying with research SOPs, GCP, FDA and OHRP regulations; ensures adherence to regulations and educates study staff. +… more
- Children's Hospital Boston (Boston, MA)
- …as well as regulatory and accreditation standards (Joint Commission, DPH, FDA , CMS). + Maintains professional skills and knowledge through educational programming, ... of progressive experience in culinary and/or clinical dietetics, with demonstrated project management and leadership skills. + Prior teaching kitchen experience is… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …(RC) works under the direction of the Principal Investigator(s), Regulatory Operations Manager and / or directly for the Clinical Trials Office to complete ... the regulatory requirements of the GYN Oncology clinical research project . The RC coordinates aspects of protocol submissions, prepares and submits regulatory… more
- North Coast Seafoods (Boston, MA)
- …Bedford. This role serves as the bridge between the Maintenance & Facilities Manager and the Maintenance Technicians, ensuring that all equipment and systems operate ... the maintenance team. This position reports to the Maintenance & Facilities Manager . Duties & Responsibilities + Lead and Supervise: Direct, mentor, and support… more
- Fresenius Medical Center (Lawrence, MA)
- …process as well as design changes . Partners with and/or guide software project teams to ensure that software systems are compliant with procedures and Regulations ... as 21CFR 820.30, IEC62304:2016 amd.1, IEC81001-5-1, as well as FDA and MDCG guidance. . Responsible for the planning...and data privacy . Compiles, maintains, and evolves approved project deliverables. . Communicates project and compliance… more
- Olympus Corporation of the Americas (Westborough, MA)
- …design control requirements and be able to effectively guide a product development project and work effectively in a cross functional team. Must have the experience ... expertise and guidance to Olympus Engineers, Marketing, Manufacturing, and Management Project leader on Exploratory, Discovery, TRP and TDP Projects. + Extensive… more
- Fujifilm (Boston, MA)
- …on systems within a service area as directed by the Area Service Manager . **Company Overview** At FUJIFILM Healthcare Americas Corporation, we're on a mission to ... 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