- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Writing is a key role responsible for producing scientifically accurate, high- quality clinical regulatory documents while adhering to regulatory ... requires collaboration across various functions to meet aggressive timelines. Clinical regulatory documents include, but are not limited to, clinical study reports,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …learned information flow based on read outs from audits, inspections, Quality Events, regulatory intelligence, effectiveness checks on process implementations ... learned information flow based on read outs from audits, inspections, Quality Events, regulatory intelligence, effectiveness checks on process implementations… more
- Aequor (Providence, RI)
- … Team by collaborating with diverse functional areas including Supply Chain, Manufacturing, Quality Control, Regulatory , Quality Assurance, Quality ... Basic Qualifications: Doctorate degree OR Master's degree & 3 years of Quality , Operations , Scientific, or Manufacturing experience, OR Bachelor's degree &… more
- Merck & Co. (Rahway, NJ)
- …solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory , Operations , Non-clinical, Clinical, and other ... multidisciplinary team environment with key stakeholders across the organizations such as Quality , Regulatory CMC, and technical functions, to ensure timebound… more
- Merck & Co. (Rahway, NJ)
- …solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory , Operations , Non-clinical, Clinical, and other ... biopharmaceutics technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory … more
- Merck & Co. (Durham, NC)
- …packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.- Partnering across our internal ... Job DescriptionOur Quality Assurance group ensures every single material inside...As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while… more
- Merck & Co. (Rahway, NJ)
- …-You will work closely with other analytical groups in ARD , Global Quality and Regulatory Affairs-CMC to ensure that validated methods are appropriately ... issue management and mitigation plan developmentSupport subject matter experts and regulatory colleagues in authoring of relevant regulatory submission… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders.Summary Accountable for support and manage Quality Management System (QMS) in accordance with regulatory requirements ... procedures to ensure adherence to the implementation of global and harmonized Quality Standards and regulatory requirements for GMP area. Responsible for… more
- Merck & Co. (Rahway, NJ)
- …teams while interfacing with other functional areas (eg project management, manufacturing, quality , regulatory affairs) and external partners to drive project ... experimental design & data analysis, authoring of technical reports, regulatory submissions and patent applications.- Active participation on formulation development… more
- Merck & Co. (Rahway, NJ)
- …phase clinical trials.- Close partnership with supply chain colleagues from Quality , Regulatory Affairs, Facilities Management, Engineering, and Analytical will ... and compliance standards. A successful candidate should have GMP facility operations experience, an affinity for hands-on problem solving, and excellent leadership… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …accuracy of laboratory documentation.Help with the implementation and interpretation of applicable quality and regulatory requirements (eg, FDA, GLP, QSR, cGMP, ... new product support.Operate and troubleshoot procedures for lab equipment, and quality and regulatory requirements important to pharmaceutical and combination… more
- Aequor (Seattle, WA)
- …standards and company policies. 2. Deviation Management: Collaborate with laboratory staff, quality assurance, and regulatory affairs teams to document and ... operations and ensure all documented processes comply with regulatory requirements. Participate in internal audits and inspections, providing necessary… more
- Aequor (Thousand Oaks, CA)
- …Quality Assurance, Process Development, Clinical Process Engineering, Analytical Sciences, Quality Control, Supply Chain, and Regulatory Affairs. Job ... organizations such as Process Development, Process Engineering, Supply Chain, Quality Control, Regulatory Demonstrated technical writing skills Demonstrated… more
- Novo Nordisk Inc. (Boulder, CO)
- …2021 to support analytical and process development, the CMC team works alongside Quality , Regulatory , Technical Operations and RNAi Early Development ... the Department The Boulder Site is home to the specialized technical operations /CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- Merck & Co. (North Wales, PA)
- …Development Statistics (LDS) and Statistical Programming (SP) staff to ensure high quality safety-related regulatory deliverables for NDA submission and periodic ... Safety StatisticsLead the interaction with Safety Physicians, Clinical Monitors, Regulatory , Early/Late Development Statistics, Statistical Programming, Data Management, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … support across all global projects; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review ... around rare diseases and immune disorders. Summary This role offers the opportunity to substantially contribute to the mission of Daiichi Sankyo in leveraging… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … support across all global projects; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …investigations and root cause analyses on any supply disruptions or material quality related issues.Support Quality , Regulatory and Financial audits.Provide ... myeloma.Legend Biotech is seeking Planner / Buyer as part of the Technical Operations team based in Raritan, New Jersey. Role OverviewThis individual will work… more
- Novo Nordisk Inc. (Boulder, CO)
- …2021 to support analytical and process development, the CMC team works alongside Quality , Regulatory , Technical Operations and RNAi Early Development ... the Department The Boulder Site is home to the specialized technical operations /CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …record keeping and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
