- 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
- Tris Pharma (Monmouth Junction, NJ)
- …knowledge or skills needed and/or licenses or certificates preferredCertified Quality Manager , Engineer or AuditorExperience working with drug-device ... Jersey, Tris has an immediate opening for a SR. Manager or Manager , Quality Management...limited to: investigative processes, CAPAs and CPIs, etc.Participates in regulatory agency inspections and customer audits, as needed; Performs… more
- Aequor (Thousand Oaks, CA)
- 100% remote - PST would be ideal Shift/schedule: Manager is flexible on days worked or number of hours per day. 20 hours per week - PART TIME!! Ideal Candidate: See ... top 3 skillsets. 4-5 YOE is preferred. In support of 's Quality Assurance program manages and oversees the operations of a specific area(s) of responsibility… 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
- 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
- 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
- Katalyst HealthCares and Life Sciences (Southern Md Facility, MD)
- …or Medical Writing experience. Must be familiar with relevant US/international regulatory requirements for medical devices including Quality Systems standards ... evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory… more
- Katalyst HealthCares and Life Sciences (Newark, NJ)
- Responsibilities: The Regulatory Affairs Manager is responsible for the development and execution of global regulatory strategy and tactical planning for ... report to the Sr. Director QRC responsible for microbiology quality , regulatory , and clinical. If you thrive...indications within a Therapeutic Area and supports the Sr. Manager Clinical Affairs in the development & execution of… more
