- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Associate Director , Regulatory Affairs, CMC will be responsible for reviewing the CMC post ... development program and life cycle management, and ensure they meet current regulatory standards, are of high quality , consistent, and complete.Establish product… more
- Insmed Incorporated (NJ)
- …other, and for the future of science, we're in. Are you?About the Role:The Director of Clinical Supply Chain Operations is responsible for leading global demand ... ensure robust supply tracking and randomization supportCollaborate with CMC, Clinical Ops, Quality , Regulatory , and Commercial Supply teams to align clinical… more
- Merck & Co. (Rahway, NJ)
- …Coordination, IT Operation, Pharmacovigilance, Policy Implementation, Regulatory Compliance, Regulatory Labeling, Regulatory Operations , Regulatory ... Business Operations Lead is expected to understand the end-to-end regulatory submission process. The main focus will be on document production processes,… more
- Insmed Incorporated (NJ)
- …patient services programs. This role serves as the primary liaison for quality operations , ensuring compliance, consistency, and operational excellence across ... of science, we're in. Are you?About the Role:The Associate Director , Patient Services Quality & Process leads...services strategy and organizational goals.This position reports to the Director of Patient Services Operations and will… more
- Insmed Incorporated (NJ)
- …expand what's possible for patients with serious diseases. Reporting to the Executive Director , Regulatory Operations , you'll be responsible for the ... Management, or related discipline, along with 1+ years of experience in regulatory operations or publishing within the pharmaceutical industry.You are or… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …a collaborative team setting with quality counterparts that include Quality Leads, site Compliance Leads, Manufacturing Operations , Technical Operations ... multiple myeloma.Legend Biotech is seeking Head of Compliance as part of the Global Quality team based in Raritan, NJ. Role OverviewThe Head of Compliance will be… more
- Insmed Incorporated (NJ)
- …and protocols/reports.Collaborate cross-functionally with CMC team, Regulatory , Clinical Operations , and Program Management to drive proactive Quality input ... of science, we're in. Are you?About the Role:The Sr. Director CMC QA will lead QA CMC oversight for...and external partners. The position is critical in shaping quality strategy, managing risk, and supporting regulatory … more
- Curia (Albuquerque, NM)
- Director , Quality Operations , Albuquerque, NM Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology ... program + Learning platform + And more! Summary: The Director of Quality Operations oversees...management systems and cleanroom aseptic facilities. + Knowledgeable with regulatory agencies (OSHA, EPA, FDA, JP, EU, etc.). Other… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Director , representing the Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and high ... fostering s culture of excellence and compliance and working toward building a quality mindset with Medical Affairs.Support the Sr. Director 's Medical Affairs … more
- Novo Nordisk Inc. (Seattle, WA)
- 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
- Formation Bio (New York, NY)
- …Partner with other CMC groups (analytical development, supply chain, etc) quality assurance, regulatory , clinical pharmacology and project management to ... and manage drug product vendors, for both development and manufacturing, ensuring high- quality deliverables and compliance with GMP and regulatory standards.… more
- BeOne Medicines (Emeryville, CA)
- …that strengthen representative patient enrollment. This role collaborates across Clinical Operations , Regulatory , Development, and corporate functions to embed ... and consistency over time. + Work actively and directly with the Clinical Operations , Regulatory , Clinical Development, and Human Resources to support their… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting into the Executive Director Packaging Technical Operations the Director Packaging Distribution, Components and Systems Center of ... relationships with internal stakeholders, including supply chain, packaging commercialization, quality , analytical, regulatory , manufacturing, Device Development and… more
- Merck & Co. (Rahway, NJ)
- …and maintain strong relationships with internal stakeholders, including commercialization, quality , analytical, regulatory , manufacturing, and Supply Chain to ... Packaging Shipping Systems (Logistics and Distribution Technology)Reporting into the Director Packaging Distribution, Components and Systems COE, the Director… more
- Merck & Co. (Rahway, NJ)
- …and maintain strong relationships with internal stakeholders, including commercialization, quality , analytical, regulatory , manufacturing, and Supply Chain to ... Job DescriptionReporting into the Director , Logistics and Distribution Technology the Associate ...Substance, Drug Product and Finished Goods globally.-The Packaging Technical Operations organization aims to be an industry leader in… more
- Insmed Incorporated (San Diego, CA)
- …provide clinical and scientific support to clinical development and operations , regulatory , medical affairs, drug safety, and quality assurance teams, as ... of science, we're in. Are you?About the Role:We're looking for an Associate Director , Clinical Scientist for the Gene Therapy Clinical Development team to help us… more
- Cipla (Central Islip, NY)
- Job Title: Director - Procurement, Cipla North America Reports to: Head SCM, Cipla North America Job Purpose The Director of Procurement is responsible for ... of materials, services, and capital expenditures necessary for pharmaceutical operations across multiple manufacturing sites and Contract Manufacturing Organizations… more
- Tris Pharma (Monmouth Junction, NJ)
- …optimal stock levels and minimize obsolescence; Ensures compliance with safety, quality , and regulatory standards in warehouse operationsManages, coaches and ... in our Monmouth Junction, NJ facility for an experienced, hands-on SR. Director / Director , Procurement. Title and salary commensurate with experience. The … more
- Novo Nordisk Inc. (Boulder, CO)
- …to our patients Work effectively across all departments, such as Quality Assurance/ Control, Chemical Development, Program Management, Regulatory , Analytical ... us. Our R&D hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop new… more
- Merck & Co. (Montgomery County, PA)
- …campaign(s) and collaborating across multiple stakeholders (including sales, marketing operations , Legal, Regulatory , Medicals, etc.) to drive promotional ... operations of the patient support program, ensuring timely, high- quality patient interactions and case management.Act as primary liaison with commercial,… more
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