- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... and serves as ad hoc member to the Global Project Team for late stage projects. This position manages...Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU… more
- Merck & Co. (Rahway, NJ)
- …arms within the business. Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans ... clinical supplies.-Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address clinical supply… more
- 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 health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Genmab (NJ)
- …the above by developing and writing corresponding SAS or other programs. The Senior Programming Manager may also serve as a compound lead.Responsibilities/tasks ... for Programming Manager , at least 6-8 years of experience for Senior Programming ManagerHas experience working in a global contextProficient in both written and… more
- Merck & Co. (Rahway, NJ)
- …and the operational/executional arms within the business. The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS ... Areas, Portfolio Management, Process Optimization, Project Management, Project Portfolio Management (PPM), Publications Management, Regulatory Compliance,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …partners and Promotional Review stakeholders Manage budgets at a project level Physical Requirements 10-20% overnight travel required. Qualifications Bachelor's ... have solid understanding of the pharmaceutical marketplace including legal, medical, regulatory , and clinical processes Ensures timely execution and follow-up, meets… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence ... support to study teams and tracking CRO and other vendor performance against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo… 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 ... least three (3) years in direct management of shop floor production activities. Project Management - Proficient with Project Management and Virtual Collaboration… more
- Vanguard (Charlotte, NC)
- …with the Archer compliance management system + Minimum of 3-5 years Compliance/ Regulatory experience + Multi-Stakeholder project management + Experience training ... is looking for a Specialist to manage the US Regulatory Change Management Process and aid CS&O with other...needs and expectations. + Accountable for regular updates on project status, risks, issues, and outcomes to stakeholders. +… more
- Robert Half Management Resources (New York, NY)
- Description Robert Half is seeking a Senior Technical Project Manager with strong regulatory remediation expertise. + Ideal Senior Risk & Project ... or OCC. + 8+ years experience in dealing with regulatory related findings such as MRA's and MRIA's or...in scope and will deal with a number of senior stake holders. + Long term engagement 6-12+ months… more
- AECOM (Boston, MA)
- …to develop professionally through frequent collaboration with senior engineers, project manager , clients, regulatory agencies, and industry-leading ... final working drawings. + Work under supervision of a senior project manager in the...+ Ability to communicate and coordinate with clients, subconsultants, regulatory agencies, and members of the public as may… more
- Boehringer Ingelheim (Ridgefield, CT)
- …and collaboration among team members, encourage cross-functional coordination and coordinate with the ( senior ) regulatory project manager to achieve ... the planning and execution of regulatory submissions coordinated by the Regulatory Project Manager . + Support submission rollout for Rest of World (RoW)… more
- Abbott (Santa Clara, CA)
- …submissions to support clinical trial activities and product launches. The Senior Manager leads project submissions for regulatory approvals and acts ... in Santa Clara, CA currently has an on-site opportunity for a ** Senior Regulatory Affairs Manager - Transcatheter** **Mitral Valve Replacement** within… more
- State of Georgia (Fulton County, GA)
- … Manager / Senior Project Manager Georgia - Fulton - Atlanta (https://careers.georgia.gov/jobs/64025/other-jobs-matching/location-only) Regulatory ... The Project Manager also performs other job-related duties as assigned. Senior Project Manager : Under broad supervision, the Senior Project … more
- Vera Therapeutics (Brisbane, CA)
- Title: Senior Manager , Clinical Regulatory Location: Brisbane, California About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage biotechnology ... improve medical treatment for patients suffering from immunological diseases. Position Summary: The Senior Manager , Clinical Regulatory will report to the… more
- Southern California Edison (Rosemead, CA)
- Join the Clean Energy Revolution Become a Senior Manager of Regulatory Dam & Public Safety at Southern California Edison (SCE) and build a better tomorrow. ... regulatory compliance? Join our team as a Senior Manager for Regulatory Dam...improving execution efficiency + Leads, manages and supports the project engineering group and remains responsible and accountable for… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …other competencies necessary to ensure engaged and productive work environments. _The Senior Manager , International Regulatory Intelligence has the following ... reasonable accommodation to individuals with disabilities. **Brief Job Overview** The Senior International Regulatory Intelligence Manager will lead… more
- Invenergy (Denver, CO)
- …be before or after the 3-day posting window. Job Description Position Overview The Manager / Senior Manager , Regulatory Affairs will represent Invenergy ... expansion. + Assist in data collection for market registration, project participation in relevant markets. + Prepare annual budgets...125,000.00 - 150,000.00 USD Annual Bonus: 25% - 40% Senior Manager , Regulatory Affairs: 145,000.00… more
- Abbott (Sylmar, CA)
- …of device and Cardiac Rythm Management solutions The Opportunity - We are seeking a Regulatory Affairs Project Manager to join our Cardiac Rythm Management ... CA. As an individual contributor, the function of a Regulatory Affairs Project Manager is...outcomes of initial product concepts and provide input to senior regulatory management + Assist in the… more
