- Formation Bio (New York, NY)
- …pertaining to developing and marketing Formation Bio's assets. This role includes the lead regulatory responsibility for support of global registration and life ... and guidance, interprets and notifies appropriate personnel and works with regulatory policy /intel. Makes recommendations for regulatory department… more
- Genmab (NJ)
- …and adherence to corporate complianceCurrent working knowledge of US-specific legal, regulatory , and compliance regulations and guidelines relevant to industry ... a Director, HEOL (Health Evidence and Outcomes Liaison) Team Lead to be a part of an exciting, passionate,...work with integrity-we do the right thingOversee direct report compliance with the Genmab Code of Conduct, guidelines and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead III as part of the Quality team based in Raritan, NJ. Role ... OverviewThe QA Investigations Lead is responsible for providing quality oversight over the...ensuring high quality and complaint product supply.Key Responsibilities Support compliance activities for site Quality Operations in accordance with… more
- CHRISTUS Health (San Antonio, TX)
- …adhere to the core values of the corporation. Directs patient care in compliance with regulatory standards such as Joint Commission and state licensure ... in the development, communication, and implementation of nursing and organizational policy and procedure. Participates on intra and interdepartmental committees and… more
- Eisai, Inc (Nutley, NJ)
- …of commercial call logs and HCP payment records Serve as the operational lead for Eisai US's Compliance Monitoring Program, managing internal resources and ... including vendor selection and onboarding Present updates to senior leadership on compliance trends, regulatory changes, and program enhancements C ontribute to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …readiness within facility and serving as an SME during the execution of regulatory inspections and audits as needed.Support compliance activities for site ... an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead I as part of the Quality team based in Raritan, NJ. Role… more
- CHRISTUS Health (Lumberton, TX)
- …in a manner that provides customer satisfaction and cost-efficient operations. Assures compliance with CAP, JCAHO, OSHA, infection control, safety, and other ... regulatory standards, including privacy and security of health information...supplies for the department in cooperation with the team lead . Performs all duties of a phlebotomist; specimen collection,… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …from early research through IND-enabling studies and into clinical development, ensuring regulatory compliance and scientific rigor in support of our pipeline ... the primary toxicology subject matter expert for interactions with regulatory agencies (FDA, EMA, etc.); support or lead...three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days,… more
- Novo Nordisk Inc. (Boulder, CO)
- …of technical teams required Experience working to standards required for regulatory compliance of Aseptic Processing facilities required Understanding of ... perform formulation studies in a laboratory setting as needed. This position will lead a team of Drug Product Managers and manage their own projects. Relationships… more
- Eisai, Inc (Baltimore, MD)
- …and system standards within the department to ensure reliability and compliance with company standards and governmental regulatory requirements. ... internal groups and coordinate calibration activities to support ongoing compliance , validation activities, operations activities, maintenances schedules, new equipment/instrument… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to reduce non-conformances in supported areas by dedicatedly driving compliance .Ensure readiness of manufacturing records for regulatory inspections ... responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations.Key Responsibilities… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … compliance with internal control processes, GxP standards, and regulatory requirements.Maintain SAP/Ariba or other ERP systems for PO creation, supplier ... and capital expenditures (CapEx), ensuring alignment with business objectives, quality, compliance , and cost optimization. The role will work closely with… more
- Eisai, Inc (Nutley, NJ)
- …experience preferred Participate in the development of brand business plans Ensure compliance with all regulatory , legal, and corporate guidelines in the ... Regulatory /Legal guidelines for healthcare provider interactions to ensure compliance . Experience working with and directing agencies and strategic vendors.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …facilities and operations teams.Perform weekly clean space walkthroughs to ensure GMP compliance .Actively participate in all regulatory and internal audits of ... and managing relationships with contractors to ensure quality of work and compliance with all company policies and regulatory guidelines.Help improve metrics… more
- Insmed Incorporated (NJ)
- …Record and cross-functional partners, including ex-US colleaguesWork closely with Legal, Regulatory , Compliance , Medical Affairs, Market Access, and Commercial ... for PAH, including positioning, messaging, and go-to-market frameworks tailored to HCPs. Lead campaign development to educate and engage PAH specialists, community… more
- Fresenius Medical Care (Claremont, NH)
- …philosophy. Adheres to the FMCNA Compliance Program, including following all regulatory and FMS policy requirements. Ensure quality patient care while ... maintaining cost-effective clinical operations in accordance with all legal, compliance , and regulatory requirements and programs. As the Charge Nurse, manages… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …infrastructure, equipment, and systems support business goals and comply with safety, regulatory , and sustainability standards. This position is a key member of the ... to unexpected issues are critical for this leader.Key Responsibilities Lead and oversee all engineering management including asset/reliability, data… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …requirements and disruption to supply.Maintain system planning parameters (eg lot size, lead -time and safety stock levels) within the site ERP.Assist with the ... any supply disruptions or material quality related issues.Support Quality, Regulatory and Financial audits.Provide timely responses to business units'… more
- Eisai, Inc (Exton, PA)
- …implementing CAPAs.Help in the administration of external stability programs, ensuring regulatory compliance , adherence to protocol requirements and timely ... The person will author protocols; reports; author and revise SOPs and lead investigations into assay failures, OOS/OOT events; direct the implementation of CAPAs… more
- Eisai, Inc (Nutley, NJ)
- …significant clinical pharmaceutical experience (ie, clinical development or operations, regulatory compliance ).Substantial experience in Clinical Quality /CQA ... is responsible for Good Clinical Practice (GCP) and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs),… more
