- Merck & Co. (Rahway, NJ)
- …modalities for clinical and/or commercial manufacturing would be idealExperience in regulatory compliance expectations across all phases of product development ... designs and executes experiments to support formulation and process development and document technical reports and regulatory filings. The successful candidate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …planning, coordination, and implementation of Development SOP activities to ensure regulatory compliance and cross functional cohesiveness across SOPs and ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...of view and provide guidance to authors to ensure regulatory compliance , consistency and connectiveness across SOPs.… more
- Aequor (Bothell, WA)
- …Cycle, and Good Documentation Practices.Comprehensive knowledge of SOPs, cGMPs, and other compliance requirements and regulatory guidelines (FDA, EU) and the ... support in our Digital Plant organization working to support, enhance, and maintain compliance for the GxP benchtop systems and instrumentation as well as site and… more
- BioAgilytix (Durham, NC)
- …to the patients who need them.In this role, you will champion quality and compliance in our solutions. Our clients trust us to deliver excellence in data and ... as applicableIssue QA statements for reports as neededAssist in hosting regulatory inspections by acting as scribe and/or reviewing documents and identifying… more
- Eisai, Inc (Nashville, TN)
- …training, marketing, managed markets, sales/business analytics, etc.)Strong understanding of pharmaceutical manufacturer compliance & regulatory ... and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... by providing input for the interaction or by writing the interaction document . May participate in meeting or teleconferences with Health Authorities Qualifications:… more
- Eisai, Inc (Nutley, NJ)
- …and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong ... clinical team for designated projects, communications, and associated documentation Document Creation and Management: Assist with creating, updating and maintaining… more
- Merck & Co. (Durham, NC)
- …LIMS sample rejections. - Equipment Calibration and ManagementFiling data sheets and document control of logbooks - Other duties requested by Management.In addition, ... production and attendant quality control problems.Strong understanding of GMPs and of regulatory requirements as they apply to the vaccine, sterile pharmaceutical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ... Matter Expert (SME) in preparation for and during internal and external regulatory audits (including FDA, EMEA).Support coordination of data collection and trend… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …standard complexity in design and geographic scope). Prepares clinical section of regulatory document . Collaborates as team member with AROs/CROs. Drafts ... Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical… more
- Eurofins USA Food Testing (North Platte, NE)
- …is accurate. Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation ... equipment operating instructions, manuals, and required logbooks. Ensures all regulatory procedures pertaining to sample testing are followed correctly, if… more
- Takeda Pharmaceuticals (Columbus, OH)
- … requirements and corporate policies, as well as work experience, to ensure regulatory compliance by assessing document requirements and identify information ... toxicology), with minimum of 10 years of leadership experience with nonclinical regulatory writing within a pharmaceutical company or Contract Research… more
- Amneal Pharmaceuticals (Brookhaven, NY)
- …Department and training records. + Perform data entry and management in systems ( Document Compliance and Process Compliance ) and maintain the print/soft ... Description: The document control specialist is responsible for administering the...for administering the processes and practices which support documentation compliance . The Specialist will work in a pharmaceutical… more
- Takeda Pharmaceuticals (Columbus, OH)
- …book roundtables, drafting regulatory notifications, coordinating and managing regulatory document workflows, inputting information into regulatory ... colleagues. + Significant experience in global drug development regulations, regulatory submissions, lifecycle management, compliance , business systems… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- …Coordinates document requests and stages documents for presentation during regulatory inspections + Implements and maintains document repositories and ... We are currently looking to fill a Supervisor, Document Control position. This position will provide support...manufacturing documentation and supporting documentation + Investigates and leads compliance items for department This role may be for… more
- Takeda Pharmaceuticals (Boston, MA)
- …of global regulatory requirements for cell therapy products and ensure compliance . **What you bring to Takeda:** + Bachelor's Degree in Biology, Microbiology, ... knowledge. **Job Description** **Job Title** : Principal Manager, Cell Therapy Quality Compliance **Location** : Cambridge, MA **About the role:** You will report to… more
- Takeda Pharmaceuticals (Boston, MA)
- …to data analytics and publication planning, including ideas for sub-analyses + ** Compliance and Regulatory :** Excellent understanding of regulatory , ... this role will be responsible for driving the publications process and ensuring compliance with global standards, and for ensuring accuracy and scientific rigor of… more
- Takeda Pharmaceuticals (Thousand Oaks, CA)
- …+ Operate and troubleshoot procedures for lab equipment, and quality and regulatory requirements relevant to pharmaceutical and combination drug manufacturing ... operating and troubleshooting procedures for lab equipment, and quality and regulatory requirements important to pharmaceutical and medical device manufacturing… more
- Takeda Pharmaceuticals (Lexington, MA)
- …as appropriate. + Document model development and validation processes, ensuring compliance with regulatory standards. + Present findings and provide insights ... will be recognized as a technical resource/expert within DPDD and across Pharmaceutical Sciences and use technical expertise to contribute across multiple projects… more
- Takeda Pharmaceuticals (Boston, MA)
- …operation, and meticulous procedural oversight of the archival function to ensure compliance to company quality standards and global regulatory requirements. The ... activities of biopharmaceutical research and development. + Ensure alignment and compliance across Takeda's document and record retention policies through… more
