- Daiichi Sankyo, Inc. (Bernards, NJ)
- …redesign and SOP authoring/coordination (Required)3 or more years with focus on pharmaceutical regulatory affairs, incl. familiarity with regulatory ... centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key...related field required Experience:4 or More Years Experience in quality management in the pharmaceutical industry and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …QualificationsMust have at least 7 or more years of professional experience in Quality and clinical development in the Pharmaceutical industry, with involvement ... Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …deriving from these contracts. Organize and conduct periodic review of contract quality and adherence PV Regulatory Intelligence:Contribute to the management of ... Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical… more
- Genmab (NJ)
- …of high- quality clinical documents to support operational, medical, and regulatory activities across the Genmab portfolio. You will help craft scientifically ... part of a dynamic, collaborative team that values innovation, quality , and scientific integrity? At Genmab, we are seeking...are seeking a passionate and experienced Senior Medical Writing Manager to help us tell the story of our… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to experiment with us? The Position The Senior Manager , Patient Support Data Intelligence is responsible for process improvement, technology, ... other documentation to assist with audits and inspections, both internal and by regulatory authorities Design, develop and manage tools which are being used to… more
- Genmab (NJ)
- …BSc. or equivalent qualificationsAt least 2-5 years of experience within the pharmaceutical industry for Programming Manager , at least 6-8 years of ... we would love to have you join us!The Programming Manager supports the development of new therapies by ensuring...adherence to standards of data and produces well-structured, high quality data summaries in tables, figures and listings for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … Knowledge: Deep understanding of FDA, EMA, and other global regulatory requirements for pharmaceutical manufacturing.Operational Excellence: Expertise in Lean ... entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize… more
- Merck & Co. (North Wales, PA)
- …study materials (eg, ICF documents / amendments); Partners with the Study Manager on study deliverables.Ensuring CRF design supports data collection in alignment ... Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality , completeness, and integrity of trial conduct.Providing tactical/scientific mentorship… more
- Merck & Co. (Rahway, NJ)
- …(e . g . , ICF documents/ amendments); Partners with the Study Manager on study deliverables. Ensuring CRF design supports data collection in alignment with ... Management/Programming. Collaborating cross-functionally to monitor clinical data -to ensure quality , completeness , and integrity of trial conduct. Providing… more
- Merck & Co. (Durham, NC)
- …DescriptionAre you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you!The ... Durham sites.- This includes Energy Center, Vaccines Manufacturing and Bulk Facilities, Quality Labs, and Maintenance and Material Storage Facility (MMSF). At times,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring) sets the vision and strategy for the...of direct reports, and mentors or acts as functional manager of skip-level or ex-US staff. This position requires… more
- Merck & Co. (Durham, NC)
- …Technician Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you! The Sr. ... The site includes clean utilities, facilities equipment, manufacturing production equipment, quality labs and a warehouse. The candidate will support the… more
- Merck & Co. (Durham, NC)
- …Technician Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you! The Lead ... an inclusive team culture including significant interaction with operations, quality , automation, technology, and other groups as required.Key Duties:Ability to… more
- Merck & Co. (North Wales, PA)
- …(Ph.D.) or 20 years of work experience (MS) in the pharmaceutical industryStrong expertise in high- quality strategic statistical decision-making, development ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Aequor (Thousand Oaks, CA)
- …systems, and procedures. Interfaces across functions including Supply Chain, Manufacturing, Finance, Regulatory , and Quality at various level of detail, to ... EOD Weds 7/23 Standard business hours Supply Chain Senior Manager - Global Supply Chain Leader What you will...the organization. 7 plus years of experience in global pharmaceutical , biotech or any other industry Solid understanding of… more
- Merck & Co. (Rahway, NJ)
- …CMC and Regulatory in aspects of control strategy and filings, Quality and our partners in the commercialization and manufacturing is essential.The successful ... of Company policy. The Executive Director will be a manager of managers, with keen focus on coaching and...diverse talent.Extensive knowledge of and hands-on work in applying regulatory guidance and quality standards related 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 ... molded Device Components, Device Constituents, and Medical Devices used to deliver Pharmaceutical , Biologic, and Vaccine Products. Our team works with a "Safety… more
- Novo Nordisk Inc. (Durham, NC)
- …our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate ... three pharmaceutical manufacturing facilities that are responsible for fulfilling different...the core processes to meet all customer, business & regulatory requirements through the following activities: People Focus, Process… more
- The Pharmacy Hub (Miami Gardens, FL)
- …is preferred. *Demonstrated understanding of GMP, FDA, OSHA, and other regulatory guidelines relevant to pharmaceutical production. *Strong project management ... About Us At The Pharmacy Hub , we collaborate with pharmaceutical brands, manufacturers, health brands, telemedicine providers, and healthcare companies to deliver… more
- Katalyst HealthCares and Life Sciences (Irvine, CA)
- …biochemistry or similar science related field preferred. Minimum 5 years of pharmaceutical regulatory or regulated content management (eg, labeling, or Company ... Responsibilities: The Regulatory Affairs Manager is responsible and...improve, implement, and maintain associated complex and simple Global Regulatory Affairs and Quality processes and business… more
