- Genmab (NJ)
- …like a fit? Then we would love to have you join us!The RoleThe Senior Manager , Clinical Programming is responsible for the establishment, governance, and ... study or portfolio-level SDTM datasets are in compliance with CDISC and regulatory submission requirements, reviews study submission data packages to ensure quality… more
- Formation Bio (New York, NY)
- …new treatments to patients faster and more efficiently.About the PositionThe Sr. Manager , GMP Quality Assurance is responsible for ensuring that all GMP-regulated ... distribution of Formation Bio's portfolio are executed in compliance with regulatory requirements, industry standards, and company procedures. This role supports CMC… more
- Novo Nordisk Inc. (Boulder, CO)
- …for patients. The Position Novo Nordisk is seeking a Quality Control Manager to support the successful start-up of the Quality Control laboratory supporting ... phase 1 and 2 oligonucleotide drug substance manufacturing. The QC Manager position will manage all activities related to the establishment & operation of the… more
- Twist BioScience (South San Francisco, CA)
- Twist is seeking a highly motivated and experienced Senior Revenue Manager to report directly to the Assistant Controller. This is a pivotal new role crucial to ... revenue accounting policies and procedures, ensuring compliance with all regulatory requirements and SOX controls.Prepare ad-hoc revenue analysis, memos, and… 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 healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Aveanna Healthcare (Madison, WI)
- …Hospice, or related healthcare settings. Strong understanding of federal and state regulatory requirements for home health agencies. Proven ability to coach, mentor, ... and develop branch leadership teams. Exceptional interpersonal, communication, and problem-solving skills. Bachelors degree required; advanced degree preferred. Licensed clinical experience preferred. Travel required up to 100%. Requirements High School… more
- Merck & Co. (Durham, NC)
- …Sustainability portfolio in its entirety involving any of the following: Regulatory compliance with internal interpretations Manage project strategy for the Durham ... guided by policies, procedures and business plan; receives guidance from manager . Provides technical guidance to employees, colleagues or contractors Anticipates and… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Associate Senior Counsel, Privacy, is a strategic, business-minded, and hands-on attorney role whose job will ... and managing Eisai's US Privacy Program, the responsibilities of the Associate Senior Counsel, Privacy, include, but are not limited to, practical and timely… more
- Merck & Co. (Durham, NC)
- …by policies, procedures and business plan; receives guidance from manager .Provides technical guidance to employees, colleagues or contractorsAnticipates and ... systems regarding functionally of equipment and relied on as SME during regulatory discussions for Utilities and the commissioning of that equipment. PROBLEM… more
- Novo Nordisk Inc. (Boulder, CO)
- …best of both worlds to develop new medicines for patients. The Position The Senior Process Engineer position will support the design, build and operation of research ... investigational products pipeline. Relationships This position reports to the Manager of Engineering. This position interacts with manufacturing, chemical… more
- Merck & Co. (North Wales, PA)
- …readiness as well as preparing for, management and follow up of regulatory inspections.Operational Quality Management:The Clinical Quality Operations Manager is ... Preparation and Management:The CQOM is responsible for maintaining current regulatory inspection knowledge as it relates to Good Clinical Practice… more
- Merck & Co. (Rahway, NJ)
- …study materials (eg, ICF documents / amendments); Partners with the Study Manager on study deliverables.Ensuring CRF design supports data collection in alignment ... engagements. This includes the ability to:Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing… more
- Repligen (Waltham, MA)
- …shared success-where every voice matters and every contribution drives progress. Join us!IT Manager , SOX & ITGC ComplianceWe are seeking an experienced IT Manager ... testing quality, reduce risk, and improve audit coverage.Stay current on regulatory requirements (SOX, GDPR, CCPA) and relevant frameworks (COSO, COBIT, NIST).Act… more
- Grifols (Brookings, SD)
- …solutions and services in more than 110 countries and regions. Job Title: CENTER MANAGER Summary: Acts as the general manager for a Plasma Collection Center ... to assigned team, other center staff and other centers. Through Assistant Manager , oversees donor selection, plasma collection and shipment and records completion.… 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 healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …standards and timelines and that quality of data is suitable for regulatory submission. The SDL collaborates with cross-functional stakeholders and the Metrics, ... of GCP. The SDL is accountable for escalation to the OPL/Asset Lead (or Senior Line Leaders in the absence of Asset Lead).Where appropriate, may delegate certain… more
- Cipla (Hauppauge, NY)
- …- 5:00PM (may vary based on business needs) Reports To : QA Validation Manager Salary Range: $68,000 - $74,600 Purpose: The incumbent to this role performs and ... project status and issues, and reports to project managers and senior management. Maintain departmental compliance pertaining to departmental SOPs, periodic review… more
- Six Flags Fiesta Texas Careers (San Antonio, TX)
- …* Uphold health & safety standards including Safe Food Handling Procedures and regulatory compliance * Train, coach, and mentor kitchen staff to grow technical skill ... experience as a Chef de Cuisine, Sous Chef, or senior kitchen leader * Strong culinary background in high-volume...systems, and labor controls * Current Food Handler and Manager Certifications (or ability to obtain) * Ability to… more
- Coty (Morris Plains, NJ)
- Senior Manager , US Regulatory Affairs and Ingredient Support ** SENIOR MANAGER , US REGULATORY AFFAIRS AND INGREDIENT SUPPORT** **COTY is looking ... the confidence and joy of expressing their beauty, their way.** As the ** Senior Manager of US Regulatory and Ingredient Support,** you will lead key… more
- ICON Clinical Research (NC)
- Senior Manager , Regulatory Affairs - IVD ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an ... IVD Location: US Remote, Portland, OR area preferred We are currently seeking a Senior Manager , Regulatory Affairs to join our diverse and dynamic team. As a… more
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