- Merck & Co. (Durham, NC)
- …focus on quality and safety compliance and unflinching focus on the customer. Author , review, and/or edit technical documents to support regulatory filings Author ... and approve validation procedures in accordance with our Company guidelines Support both internal and regulatory audits with coaching Subject Matter Experts (SMEs) and presenting to auditors as needed. Act as a validation subject matter expert in support of… more
- Merck & Co. (Rahway, NJ)
- …Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA) principles. Author technical reports, analysis certificates, investigations/deviation records, ... and SOPs. Perform data entry, data review/approval, and author analytical reports or data summaries.Troubleshoot and lead any investigations associated with GMP… more
- Formation Bio (New York, NY)
- …documents (eg, annual reports/developmental safety update reports) by serving as the document author or providing oversight to the assigned author . Partners with ... Formation Bio's tech team members to innovate and streamline regulatory writing processes through a combination of programmed automation solutions and the use of generative AI tools Creates the timelines, in conjunction with the project team or relevant… more
- Formation Bio (New York, NY)
- …with CDMOs, contract laboratories, consultants, and acquisition partners. Documentation: Author , review and approve analytical technical documents and standard ... to assure compliance with current GxP regulations. Regulatory submissions: Author , review and strategically contribute to regulatory submissions, including INDs,… more
- Merck & Co. (Durham, NC)
- …Solving initiativesEquipment and process troubleshootingSupporting on-shift Operations Coaches (M1) Author deviations and works to coordinate, develop and implement ... Corrective Actions/Preventive Actions (CAPAs)Lead implementation of MPS principles on the shop floorSample managementAbility to effectively support, upskill and mentor new employeesAnalyzing and implementing initiatives that will help to increase overall… more
- Aequor (Seattle, WA)
- …technical content for significant documents such as validation activities, author content for regulatory submissions.Ensure technical and manufacturing requirements ... are addressed throughout lifecycle of new solutions.Provide necessary technical analysis to support impact assessments and investigations.Function as a subject matter expert for autologous T-cell therapies and manufacturing technologies.Provide technical input… more
- Merck & Co. (Durham, NC)
- …inventories, and transports all required equipment, materials, supplies and products. Author , review, and/or edit procedures and technical documents to support ... regulatory filings including standard operating procedures, job aides, and learning documents.Performs general maintenance and assists or ability in troubleshooting of equipment independently.Performs housekeeping in all work areas. Executes facility… more
- Merck & Co. (Rahway, NJ)
- …of responsibilityTo accomplish these goals, the Senior Principal Scientist may: Author detailed development documents, presentations, budgets, and position papers for ... internal and external audiencesCollaborate with external experts/researchers around the world with a specific interest and expertise related to Precision MedicineTravel on company business about twenty (20) percent of the time to manage future or ongoing… more
- Merck & Co. (Boston, MA)
- …of responsibility. To accomplish these goals, the Senior Director may: Author detailed development documents, presentations, budgets, and position papers for ... internal and external audiencesFacilitate collaborations with external researchers around the worldTravel on company business about twenty (20) percent of the time to manage future or ongoing clinical research projects.Qualifications Education MD or… more
- Aequor (Swiftwater, MN)
- …in completion of change controls, deviations, CAPA's to support timelines Author cGMP documentation including protocols, reports, procedures, and user requirement ... specifications Assist in implementing new technologies to improve QC testing efficiency and capabilities Support QC laboratory inspection readiness Develop an understanding of best practices for optimal equipment operation and compliance to regulatory… more
- Formation Bio (New York, NY)
- …CMC activities comply with global regulatory expectations (eg, FDA, EMA, ICH); author and review regulatory submissions including INDs, BLAs, and other key ... documents. Continuous Improvement Stay current with emerging technologies, regulatory changes, and industry best practices; drive continuous improvement across all CMC operations. About YouRelevant Experience 10+ years of experience in the biopharmaceutical… more
- Aequor (Tampa, FL)
- …Develops and executes validation protocols for test methods and equipment qualification. Author and review SOPs and test methods related to microbiology. Ensure the ... microbiological integrity of environment, equipment and facilities. Manages product testing based upon internal and customer specifications. Managing 3rd party laboratory testing and reporting of data and EM when necessary. Report on testing results, including… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Affairs CMC, and Clinical Development to collate the necessary information to author the Dose Preparation Instructions and address questions from the clinical sites. ... The candidate will optimize and continuously improve the Pharmacy Manual (PM) template with inputs from internal and external stakeholders. Collaboration with external stakeholders (eg, research pharmacists, clinical study partner management) may also be… more
- Merck & Co. (South San Francisco, CA)
- …for providing timely and high-quality PDMB data deliverables to teams. Author regulatory documents from FIH through registrational filing.Effectively partner across ... multidisciplinary interfaces and provide strategic DMPK guidance and support to drive new drug discovery and development.Contribute to departmental scientific initiatives and strategies; Foster a high-performance culture of innovation, collaboration,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …vendors.Provide SME support for regulatory inspections and regulatory filings. Author /Review/Approve documents for departmental standard operating procedures (SOPs) ... to ensure qualification activities are maintained to the highest standards. Author and execute Change Controls and Impact Assessments for Engineering/Facilities… more
- Merck & Co. (Rahway, NJ)
- …development, and scale-up activities, quality investigations and change management, and author GMP standard operating procedures and protocols in support of facility ... operations.Education Minimum Requirement: Master's degree in Chemical Engineering, Chemistry, Industrial Engineering, Pharmaceutical Sciences or closely related scientific field with 2 years relevant experience OR a Bachelor's degree in Chemical Engineering,… more
- Access Dubuque (Dubuque, IA)
- Author Account Manager **Kendall Hunt Publishing Company** 1 Positions ID: 68982 Posted On 05/22/2025 **Job Overview** Join our team at Kendall Hunt Publishing as an ... Author Account Manager in Dubuque! Immerse yourself in a...with our talented authors. Unlock the excitement of managing author relationships, ensuring their needs are met and their… more
- Lockheed Martin (Fort Worth, TX)
- **Description:** **F\-16 Technical Publications Author \- Level 1** **Location: Fort Worth TX** **What You Will Be Doing** As an F\-16 Technical Publications ... Author - Level 1, you will play a key...of the F\-16 fleet\. **Key Responsibilities** \- Develop and author accurate, clear, and user\-friendly maintenance instructions and technical… more
- Publicis Groupe (Los Angeles, CA)
- …opportunities for the company and executing them. General Summary: The Content Author is responsible for entering content (images, copy, video, HTML, CSS) across ... multiple CMS platforms. The Content Author maintains a high level of understanding of our client's content, products and CMS platform. This role collaborates closely… more
- R1 RCM (Boise, ID)
- …analytics, AI, intelligent automation, and workflow orchestration. As our **Utilization Review Author ** , you will help our hospital clients by working alongside our ... position. **Here's what you will experience working as a Utilization Review Author :** + Perform initial admission and continued stay reviews utilizing InterQual or… more
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