- Merck & Co. (Durham, NC)
- …of assigned activitiesComply with company health and safety procedures and practices. Author SOPs and technical documents Other duties as needed Education Requirement ... the pharmaceutical industry Demonstrated technical writing ability; able to author protocols and reports Demonstrated structured problem-solving skills; able to… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …control correct and give guidance to director reports. The laboratory supervisor may author or co- author methods, SOP's and continuing scientist reports in their ... area of expertise. The work is performed in a highly regulated environment and compliance with documentation standards is required, will perform all other related duties and tasks as required or assigned. QualificationsBachelor's degree in a scientific area or… more
- Merck & Co. (North Wales, PA)
- …and external partners, design non-interventional and data synthesis studies, author study protocols, develop measurement questionnaires, case report forms, data ... analysis plans, final study reports, scientific presentations, and publications.Responsible for study-related contracting, budgets, and vendor/partner management.Develop American Managed Care Pharmacy (AMCP) dossiers for US payers, and Global Value… more
- Merck & Co. (Rahway, NJ)
- …cell protein analysis.Represent the mass spectrometry group in project teams. Author regulatory submission sections and responses, technical reports and scientific ... presentations.Explore and develop new technologies to advance the field of mass spectrometryDemonstrate effective multitasking, prioritization and problem-solving skills in the planning and execution of experiments.Mentor and share expertise across the Mass… more
- Merck & Co. (Rahway, NJ)
- …responsibility. To accomplish these goals, the Senior Clinical 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, DO,… more
- Merck & Co. (Rahway, NJ)
- …in the program-specific design controls process and design history file development. Author and review relevant portions of the regulatory submissions (INDs, IMPDs, ... NDAs, BLAs, etc.) for combination product programs under your leadership.Manage and develop team members leading the internal engineering core teamsRemain current in relevant worldwide regulatory guidance and standards.Lead/support/oversee clinical supplies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …narratives- May lead the development and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of the other sections in ... collaboration with the other authoring functions- Accountable for Protocol content/study design development- Contributes from a medical strategy standpoint to the development of clinical sections of study-level documents (eg, protocol, amendments)- of safety… more
- Insmed Incorporated (San Diego, CA)
- …batch records, SOPs, raw material specifications, GMP protocols, and author development reports.Demonstrate experience with process validation and scale-down models ... situations or data requires an in-depth evaluation of variable factors. Author Standard Operating Procedures, technical reports, process descriptions, including data… more
- Aequor (Bothell, WA)
- …for method transfer and/or validation internally and externally for assigned program(s). Author or review protocols and reports for method transfer and/or method ... validation or method bridging, and other technical development reports associated with methods. Plan and track method transfer and/or method validation deliverables. Collaborate and interact with internal global QC testing sites/labs and external testing… 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 Conducts general maintenance and assists or ability in troubleshooting of equipment independently Initiates housekeeping in all work areas - Executes facility… more
- Merck & Co. (Durham, NC)
- …direction and guidanceDeviation management, Review and approve Quality Notifications (QNs) Author , review, and approve SOPsTake on project management opportunities, ... by leading and participating in process improvement, learning events, or business support initiatives, as guided or approved by Quality managementTrain employees on new or revised processes or proceduresDetermine staffing needs and hire to meet those… more
- Merck & Co. (Rahway, NJ)
- …ensure safety and quality of clinical supplies to augment and accelerate our products. Author and review GxP documentation including but not limited to batch records, ... specification, equipment qualifications, change records and deviations.Build partnerships by developing and leveraging relationships within and across work groups of formulators, engineers, safety and quality representatives.Foster culture of collaboration,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review global policies, inspections and audit CAPAs, and vendor audit documentation.- Author , update and maintain Global DX Computer System Validation policies and ... procedures in collaboration with global DX and global Quality departments. Evaluates key performance indicators and participates in SDLC Lessons Learned sessions to evaluate validation process improvements and efficiencies and measure key success factors.-… more
- Aequor (Framingham, MA)
- …experimental work and results with appropriate supervision and documentation. Author high quality scientific and operational documentation and deliver scientific ... presentations.Basic qualifications Master's degree (2-4 years) or PhD degree (0-2 years) in Biotechnology, (Bio)Chemical engineering, Biology, Biochemistry, or a related field. Relevant knowledge, coursework and/or hands-on experience in mammalian cell culture… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure the compliance for products marketed and/or distributed locally. May author or review stability studies protocol or reports. Provide the support for ... management and update of technical registration documents- Quality Metrics: Collecting and analyzing data related to deviations, CAPA, Change Controls, OOS, and internal/external audits performance and reporting Quality Metrics in a periodical manner and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …safety narrativesMay lead the development and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of the other sections ... in collaboration with the other authoring functionsAccountable for Protocol content/study design developmentContributes from a medical strategy standpoint to the development of clinical sections of study-level documents (eg, protocol, amendments)Reviews safety… more
- Merck & Co. (Rahway, NJ)
- …This role may support facility operations, support compliance investigations/change management, author GMP documentation and manage/lead engineers in any of our ... enabling facilities. Additional Supported Areas: As required and in addition to support of the Prep Lab the Specialist may provide direct support to other areas such as:Small Scale Organics Pilot Plant (SSO): - The SSO is a Good Manufacturing Practice (GMP)… more
- Merck & Co. (North Wales, PA)
- …in his/her area of responsibility.To accomplish these goals, the Director may: Author detailed development documents, presentations, budgets, and position papers for ... internal and external audiencesFacilitating 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. QualificationsEducation:M.D or… more
- Novo Nordisk Inc. (Durham, NC)
- …FIFO, returns, etc. Participate actively in & support event response Review & author SOPs & other documents as required Identify, report & resolve quality issues ... Execute &/or assist during equipment maintenance, including restoration of lost function, predictive & preventative maintenance Train fellow employees in areas of expertise & aggressively learn systems & equipment outside of own expertise (with the appropriate… more
- Aequor (Bothell, WA)
- …Transfer manufacturing processes to internal and/or external manufacturing facilities Author technical reports and make presentations to scientists and management ... ORGANIZATIONAL RELATIONSHIPS: Work with fellow Bioprocess, Analytical and Pharmaceutical R&D scientists across multiple sites EDUCATION AND EXPERIENCE: Minimum Bachelor's degree with 2-4 years of relevant experience or Masters degree with 0-2 years of relevant… more
