- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as other research areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global ... and compliant with relevant regulations. This role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality , CSPV, Clinical Operations,… 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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …GMP documents. Ensure all API are manufactured in compliance with cGMP and regulatory filings. Perform independent quality review and approval of batch records, ... communications with all stakeholders in all manufacturing operations, analytical testing, quality assurance, regulatory , etc. at all levels. Establish, educate,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Manager , Internal Process Audits is responsible for end-to-end GxP relevant audit ... audits effectively. Ensure the internal systems auditing program fulfills regulatory requirements performs audits, identifies compliance issues and trends, reviews… more
- Merck & Co. (Millsboro, DE)
- …an interdependent global manufacturing network that's committed to delivering a high quality , reliable supply to customers and patients on time, every time.Our ... departmentsReview and revise processes and procedures against corporate and regulatory policies.Review production records for completeness and compliance to… more
- Merck & Co. (Rahway, NJ)
- …Payments Manager will help lead the strategic direction, operational quality , and innovation of the credit union's payments ecosystem, including card services, ... critical role in driving member satisfaction, improving efficiencies, and ensuring regulatory compliance while advancing the credit union's payments strategy in… more
- Repligen (Waltham, MA)
- …manage Supplier Change Notifications to ensure compliance with internal and regulatory quality standards.Coordinate cross-functional teams to assess and mitigate ... accountability, supporting root cause investigations, and ensuring Repligen's supplier network meets regulatory and quality standards. This role is based in… more
- Aequor (Thousand Oaks, CA)
- …and accuracy. Job Summary This position is a unique opportunity to work within Quality Control at the Thousand Oaks site and to directly support both manufacturing ... and Quality Control operations. Under minimal supervision analyze environmental monitoring...with safety guidelines from EHSS, cGMPs, and other applicable regulatory requirements. Adhere to good documentation practices. Complete all… 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 ... language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the management of… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance, GCP/Document Audits supports end-to-end audit activities ... File (eTMF) and other pivotal documents to be submitted to the regulatory authorities for application Qualifications: Successful candidates will be able to meet… more
- Genmab (NJ)
- …like a fit? Then we would love to have you join us!The Programming Manager supports the development of new therapies by ensuring integrity, consistency and adherence ... to standards of data and produces well-structured, high quality data summaries in tables, figures and listings for...of at least one study are in scope.The Programming Manager will support the Data Management, Statistics, Drug Safety,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …related to US Talent Acquisition. Ensures utilized solutions are compliant with regulatory requirement and advises on the same. Ensures Talent Acquisition functions ... and continually improve data representation and delivery applications (including data quality ) in support of US Talent Acquisition Evaluates processes within Talent… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager , and Manager .Oversee the hiring, development, and performance management ... size.Responsible for multiple work centers within the facility to ensure high quality and compliant product supply and oversee production metrics; these metrics will… 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. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs.--The AVP provides leadership and direction through senior-level and… 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
- Twist BioScience (South San Francisco, CA)
- …by collecting, analyzing, and summarizing information and trendsWrite/review product quality documentationFollow regulatory and ISO 13485 requirementsWhat You'll ... He/she will work closely with the operations team to monitor the quality of Twist DNA products utilizing quantitative measurements, fragment analysis, NGS… more
