- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/ EU Directive, and International Conference on Harmonization (ICH) guidelines.The ... Senior Clinical Study Manager will have routine interaction with key internal and...routine interaction with key internal and external stakeholders communicating project status, escalating issues, and troubleshooting routine inquiries. Expert… more
- BioAgilytix (Durham, NC)
- … EU Medical Device requirementsCE Mark product certifications experienceDemonstrated project coordination and management skills; strong experience in a QMS ... life-saving therapeutics to the patients who need them.The Regulatory Affairs Manager is responsible for coordinating the regulatory activities for projects… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence ... Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/ EU Directive, and International Conference on Harmonization (ICH) guidelines.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process ... with key stakeholders, including Regulatory Affairs teams and cross-functional project team members, to gather business requirements for reporting and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/ EU Directive, and International Conference on Harmonization (ICH) guidelines. ... affairs operations clinical trial activities, ensuring adherence to timelines, budgets, project , and quality plans, and relevant ICH/GCP Guidelines Review protocols… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and other agency auditsEnsure site/system validation program meets FDA, ISO and EU requirementsCollaborate with peers and stakeholders to in QA and Manufacturing to ... assigned Required Skills:Must have exceptionally strong communication, interpersonal and project management skillsAbility to multi-task and methodically manage projects… more
- Aequor (Newbury Park, CA)
- This will be a 100% remote role. The hiring manager confirmed they are looking for someone who works regular hours (7a-4p or 8am-5p etc)/ with EST timezone ... in SharePoint, has working experience with the Six Sigma method and project management experience. The type of qualities/characteristics the hiring manager … more
- CohnReznick LLP (Tysons Corner, VA)
- …do! We currently have an exciting career opportunity for a Sustainability Advisory Manager to join our Sustainability Advisory team.This is a virtual position. A ... on emerging ESG reporting regulations, such as CA SB-253 and SB-261, EU CSRD, SEC Climate-Related Disclosures, and Building Energy Performance Standards.Knowledge of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and support the PRA strategies and tactics of additional indications. With manager oversight, the individual will lead global pricing strategy development, access ... - capable of driving large, complex work streams required- Strong project management skills; demonstrable experience in managing multiple cross-functional projects… more
- Amazon (Seattle, WA)
- …standard processes that are relevant for the program. Finally you will manage the pan- EU deep dives with payment processors or ACSs. We are open to hiring candidates ... locations: Seattle, WA, USA Basic Qualifications - 5+ years of program or project management experience - Experience using data and metrics to determine and drive… more
- Amazon (Nashville, TN)
- Description Sr. Governance Manager , Workplace Health & Safety (WHS) will be responsible for strategic legal compliance, including assurance processes design, ... at an advanced level - Bachelor's Degree Preferred Qualifications - Project Management Professional (PMP) or equivalent certification - Experience leveraging… more
- Abbott (Maple Grove, MN)
- …Maple Grove, MN currently has an opportunity for an on-site **Senior** **Clinical Scientist/ Project Manager Clinical Evaluation** . This new team member will ... and therapeutic area knowledge to support Regulatory Affairs medical device submissions in the EU for CE Marking of new devices and maintaining of CE Mark for… more
- PPL Corporation (Allentown, PA)
- …and investments in organizations that support education, sustainability, and wellbeing. Overview The Project and Contract Manager position is the single point of ... and Substation). Responsible for the successful delivery of assigned project portfolio. Responsible for all project and... governance structure that has been implemented by PPL EU management. 16. Proactively identify risk and mitigation plans,… more
- ThermoFisher Scientific (Greenville, NC)
- … Delivery is vital to helping our customers deliver life-changing therapies. Role: Senior Project Manager OR Project Manager Location: Remote, Homebased, ... North America Discover Impactful Work: We are seeking a Project Manager /Lead in within our Functional Service Provider Team. This role will be hired at … more
- Stryker (Redmond, WA)
- …evaluative judgements based on the analysis of information. The primary responsibility of the Project Manager , Enterprise PMO is to use project management ... commercial operations in various ventures for our products. This project manager will be responsible for multiple...required + PMP or equivalent preferred + Knowledge of EU MDR and/or FDA Medical device requirements is preferred… more
- Jacobs (Cary, NC)
- …that we're making a difference. As a Commissioning, Qualification, and Validation (CQV) Project Manager , you'll join our collaborative team providing CQV ... and safety. We are looking for a passionate CQV Project Manager who is driven by collaboration,...of US FDA (21 CFR 210, 211, 810) and EU EMEA regulations * Knowledge of industry guidance: o… more
- DAI (Bethesda, MD)
- ** Manager , Project Management Central Asia, Afghanistan, and Pakistan** City/Country Location Details **Bethesda, Maryland** Employment Status Job Type ... **Corporate** Job Title/Grade: Manager , Project Management Central Asia, Afghanistan, and...corporate offices in the United States, the United Kingdom, EU , Nigeria, Pakistan, and Palestine and project … more
- New York University (New York, NY)
- Position Title: Research Project Manager School: NYU's School of Global Public Health | Social and Behavioral Sciences Supervisor: Dr. Jennifer Cantrell ... School of Global Public Health is seeking a Research Project Manager to work directly with faculty...considerations when extending an offer For people in the EU , click here for information on your privacy rights… more
- Jacobs (Cary, NC)
- …a difference. As a Commissioning, Qualification, and Validation (CQV) Start-Up/Commissioning Project Manager , you'll join our collaborative team providing ... manufacturers. We are looking for a passionate CQV Commissioning Project Manager who is driven by collaboration,...of US FDA (21 CFR 210, 211, 810) and EU EMEA regulations * Knowledge of industry guidance: o… more
- Insight Global (Tampa, FL)
- Job Description The Project Manager (Deployment) manages, plans and implements multiple transformational projects in security and technology services (IT) within ... several company entities in the EU . This position serves as the liaison between the...liaison between the entity's stakeholder and the core global project team/PM. The PM will act in coordination with… more
