- Mount Sinai Health System (New York, NY)
- **Job Description** The ** Project Manager II** will oversee the entire portfolio of Investigator-Initiated Clinical Trials (IICTs)/Clinical Research Sponsor ... compliance with regulatory requirements, and facilitating collaboration among multidisciplinary teams to meet project goals. The Project Manager II will work… more
- Mount Sinai Health System (New York, NY)
- **Job Description** The Project Manager I oversees the operational aspects and scope of a specific project or ongoing department initiatives. S/he supports ... 5+ years with Bachelor's degree; 3-5 years of experience in program, project , or research administration within an academic setting preferred. + Familiarity with… more
- Unither Pharmaceuticals (Rochester, NY)
- Production Maintenance Manager Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and ... to the Michael Cifuentes, JOB SUMMARY: The Production Maintenance Manager is responsible for maintenance of all equipment used...a functional efficiency standpoint and in compliance with the FDA requirements to have and use a formalized equipment… more
- Chobani (New York, NY)
- …performance testing, safety validation, and regulatory compliance verification with project manager coordination Technical Documentation: Create engineering ... Summary The Senior Manager , Mechanical Engineer will serve as the technical...mentoring 2-3 engineers and collaborating with creative, product, and project management teams. Working alongside our Industrial Design team,… more
- Oracle (Albany, NY)
- …EHR and AI-enabled medical device platforms. As a Clinical Product Manager (Medical Device Focus), you'll provide clinical insight into product design, ... Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …products and drug-device combination products. Ensure compliance with global regulations ( FDA , EMA, ICH, WHO) and anticipate regulatory changes impacting CMC ... Health Authority questions and deficiency letters. + Represents CMC RA in project team meetings and provides expert interpretation of regulatory guidelines and… more
- Wolters Kluwer (New York, NY)
- The **Principal SaMD Technical Program Manager ** plays a pivotal role in driving the development and delivery of Software as a Medical Device (SaMD) products. This ... ensuring strict compliance with global regulatory standards such as FDA , EU MDR, ISO 13485, and IEC 62304. They...dependencies. They provide oversight to various aspects of the project portfolio, coordinating meetings and project deliverable… more
- Lactalis American Group Inc. (Buffalo, NY)
- Quality Customer Relations Manager Buffalo, NY (http://maps.google.com/maps?q=2376+South+Park+Avenue+Buffalo+NY+USA+14220) Description Ready for more than just a ... of the Lactalis family of companies, is currently hiring a Quality Customer Relations Manager based in Buffalo, NY. The Quality Customer Relations Manager serves… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. Works ... the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. - Works… more
- Mount Sinai Health System (New York, NY)
- …This role ensures high-quality, efficient study execution consistent with institutional, FDA , and ICH/GCP standards. The Manager leads cross-functional study ... **Job Description** The **Clinical Trial Manager ** provides leadership and oversight for the planning,...degree or equivalent advanced training in clinical research or project management preferred. + 6+ years of experience managing… more