- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory ... CMC regulatory experienceSuccessful track record in preparation, management of review and approval of NDA/MAA/BLA with FDA and EMA Competencies: Advanced… more
- Genmab (NJ)
- …feel like a fit? Then we would love to have you join us!The Role:The Senior Statistical Manager acts as a biostatistician supporting the clinical development of ... methodologies that may support innovation and improve efficienciesEngage with regulatory authorities on compound/indication level discussionsActs as a role… more
- Genmab (NJ)
- …quality, and scientific integrity? At Genmab, we are seeking a passionate and experienced Senior Medical Writing Manager to help us tell the story of our ... science through compelling clinical and regulatory documents. You'll be at the heart of a...trial teams to manage timelines, facilitate meetings, and lead review cycles.Provide expert peer review and editing… more
- Merck & Co. (North Wales, PA)
- …scientist on the clinical trial team.Leading medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaborations with ... study materials (eg, ICF documents / amendments); Partners with the Study Manager on study deliverables.Ensuring CRF design supports data collection in alignment… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring) sets the vision ... technical and career, of direct reports, and mentors or acts as functional manager of skip-level or ex-US staff. This position requires strong knowledge about RBQM,… more
- Merck & Co. (Rahway, NJ)
- …chain deliverables and prepares , analyses , and/or develops mitigation strategies for review with clinical partners and senior leaders.- - Works directly in ... the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM) designs strategic and operational plans for all activities… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …daily production schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager , and Manager .Oversee the hiring, development, and ... change controls, and maintain permanent inspection readiness and actively support regulatory inspections.Lead facility operating review meetings and sponsor… more
- BURNCO LLC (Henderson, CO)
- …business acumen and exceptional relationship-building abilities? BURNCO is seeking a General Manager to lead our Ready-Mix division in Colorado. Join us in building ... Build and maintain strong relationships with community stakeholders, industry partners, and senior customers Develop, lead, and collaborate with the HSE team to… more
- Merck & Co. (Durham, NC)
- …our Manufacturing Division (Associate Director).-This role serves as a Virtual Plant Manager - responsible for leading a cross-functional team in oversight of our ... Reliability, and Lifecycle Management). Lead Periodic Business and Operations Review Meetings (with External Partner).-- Compliance:-Achieve compliance goals through… more
- Katalyst HealthCares and Life Sciences (Tarrytown, NY)
- …CMC team to ensure highly qualified personnel that can perform to meet company KPO Preparation, Review , and filings of new ANDA, NDA, IND and DMF for the US FDA in ... eCTD format. Preparation, Review and filing of all post marketing activities which...of PLAIR activities, prior to new product launch. Manage regulatory correspondence mainly to CDER, FDA, User fee staff,… more
- Citigroup, Inc. (Tampa, FL)
- The Regulatory Reporting Manager -Securites Services accomplishes results through the management of small professional team(s) and department(s) or as an ... analytics, information management across Investor Services products and reports to senior management. Responsible for communicating to Regulatory Reporting… more
- Lifelancer (Andover, MA)
- About the job Senior Manager - Study Site Management (US - Remote) Job Title: Senior Manager - Study Site Management (US - Remote) Job Location: Andover, ... site relationships that accelerate life-changing abilities? Join our mission-driven team as a Senior Manager - Study Site Management and play a pivotal role… more
- The Judge Group Inc. (Bridgeport, PA)
- Our client is currently seeking a Senior Program Manager - Reimbursement for a 3 months + contract. Senior Program Manager - Reimbursement - Acute Must ... report submissions for assigned hospitals or other entities and related desk review and audit activity (including wage index reviews or other Medicare/Medicaid… more
- Southern California Edison (SCE) (Pomona, CA)
- …seeks approval from management in accordance with applicable policies, procedures and guidelines; with review of a senior manager or principal manager ; ... Join the Clean Energy Revolution Become an Engineering Senior Project Manager at Southern California Edison (SCE) and build a better tomorrow. Grid Architecture… more
- Applied Research Solutions (Bedford, MA)
- ARS is currently searching for a Senior Program Manager at Hanscom AFB in Bedford, MA. This will require a TS/SCI/SAP clearance. Why Work with us? Applied ... attention from ARS Senior Managers. As a Senior Program Manager at ARS, you will:...objectives. Develop and support acquisition reports, including statutory and regulatory reports (eg, DAES, MAR). Participate in program management… more
- City National Bank (New York, NY)
- RELATIONSHIP MANAGER SENIOR 6th Avenue, New York, NY WHAT IS THE OPPORTUNITY? Responsible for acquiring small business and personal clients, and will be ... and Credit policies and procedures as well as all regulatory requirements (eg Bank Secrecy Act, Know Your Client,...its impact on clients. Personal & Business Financials - review financial statements to fully understand a client's financial… more
- EPM Scientific (San Diego, CA)
- Title: Senior Specialist/ Manager of Regulatory Affairs Summary: A global leader in medical technology is seeking an experienced and driven Regulatory ... while maintaining compliance Review and approve product labeling, promotional materials, and advertising content to ensure adherence to regulatory standards more
- Blink Health (New York, NY)
- …Join us! About the Role We are seeking a strategic People Operations Program Manager to lead the transformation and scaling of our people operations processes. This ... efficient, scalable HR shared services. Key Responsibilities Conduct comprehensive review of current people operations processes to identify inefficiencies and… more
- Stantec (Burlington, MA)
- …You are accountable for making decisions on large projects. You coordinate with the regulatory review to seek final approval. You manage projects of varying ... Your Opportunity We are looking for a talented Water/Wastewater Sr. Project Manager focused on the planning and engineering design of wastewater infrastructure… more
