- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA) ... function, responsible for ensuring Daiichi Sankyo's Regulatory processes & procedural documentation are fit for purpose and compliant with relevant regulations. This… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health outcomes. Are you ready to realize your potential? The Position The Manager - Market Access Insights assesses product and customer performance for all ... a fast-paced, environment, with a quality control focus and a documentation orientation Creative problem-solving with ability to solve complex unstructured problems;… 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 ... for the conduct of clinical trials and creation of regulatory submission documentation with the ability to provide interpretation and guidance for internal and… more
- Twist BioScience (South San Francisco, CA)
- Staff Program Manager (Hybrid in South San Francisco, Portland, OR or Carlsbad, CA) Twist Bioscience is at an exciting phase of growth in business. The Program ... Management Office (PMO) is seeking an experienced, highly-motivated program manager to enable the tremendous growth of Twist's Next Generation DNA synthesis… more
- Genmab (NJ)
- …of programming specificationsDrive consistency across trialsResponsible for keeping proper documentation and filing to eTMFProvide sponsor oversight of vendor ... programming activitiesSupport in-house production of analysis datasets, tables, figures, and listings, by writing programs and ensuring QC before formal release, for deliverablesPerform QC on SAS-code written by other Genmab colleaguesSupport submissions by… more
- Merck & Co. (Rahway, NJ)
- …Operations - API, is responsible for independent review and approval of documentation to support Good Manufacturing Practice (GMP) clinical supply API manufacture, ... clinical supply programs. This person will also independently review and approve documentation accompanying the disposition of API materials to ensure conformance to… more
- Aequor (Thousand Oaks, CA)
- …EHSS, cGMPs, and other applicable regulatory requirements. Adhere to good documentation practices. Complete all required training before starting any tasks. Work ... with relevant team members. Implement prevention or corrective actions based on lab manager feedback. Perform QC Support tasks eg, organization and cleaning of the… more
- Aequor (Pearl River, LA)
- …preparation areas of the cGMP commercial manufacturing facility. Requires good documentation skills and attention to detail. Duties will include the operation, ... issues, troubleshoot, propose solutions, and keep management informed. Ensure good documentation practices (GDP) in execution and reviews of production records.… more
- Merck & Co. (Rahway, NJ)
- …GMP and developmental use.- Author, review and approve GMP procedures and documentation , with an emphasis on Qualification and Validation plans around equipment, ... plans and annual reports around critical equipment and systems.- Maintain GMP documentation where applicable, such as GMP engineering drawings and equipment database… more
- Genmab (NJ)
- …from/to business partners in collaboration with the programmer and the data manager , as applicableEnsures state of the art statistical work which includes but ... adequate methods for which a solid scientific foundation existsEnsure proper documentation of work doneKeep oversight and QC essential documents/data provided by… more
- BioAgilytix (Durham, NC)
- …is seeking a Scientist III to serve as Bioanalytical Project Manager (BPM)/Principal Investigator (PI), overseeing all aspects of bioanalytical studies-including ... shape the future of healthcare.Essential Responsibilities:Serve as Bioanalytical Project Manager (BPM)/Principal Investigator (PI), overseeing all aspects of bioanalytical… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …candidate will be commensurate with experience. Relationships Reports to: Manager , Process Support (Downstream) Essential Functions Assist with coordinating ... as needed Write and review protocols, summary reports and other documentation associated with verification, and validations Coordinate scheduling of verification… more
- Astronics (Waukegan, IL)
- Technical Documentation Manager Astronics Subsidiary Waukegan, IL & Lake Zurich IL Location Astronics CSC Description Astronics Connectivity Systems and ... internal specifications and industry standards. Lead and train the Technical Documentation Team, with guidance from the responsible director. **Essential Duties and… more
- AdventHealth (Maitland, FL)
- …and 125,000 outpatients each year **The role you'll contribute:** The Clinical Documentation Integrity Manager is a Registered Nurse and/or a Registered ... level of clinical proficiency necessary for the oversight of the Clinical Documentation team which is comprised of registered nurses and clinical documentation… more
- COOLSOFT (Madison, WI)
- UAT Documentation Stakeholders Manager (Jobs in Madison, WI) Requirement id 154460 Job title Manager Job location in Madison, WI Skills required SCRUM ... DOE Status requirement Job interview type Email Recruiter:coolsoft Job Description Manager : SCRUM Development, CSM Certification, UAT, Documentation Stakeholders… more
- Siemens Energy (Orlando, FL)
- **A Snapshot of Your Day** **Documention Manager - Americas** As the Manager of the Documentation Team for the Americas, you'll begin each day by connecting ... is dynamic and hands-on, involving the coordination and oversight of documentation workstreams, setting clear priorities, diving into technical project details, and… more
- System One (Florham Park, NJ)
- Job Title: Manager , Regulatory Operations Documentation Specialist - Contractor Location: Florham Park, New Jersey - hybrid 50% Type: Contract Compensation: $65 ... - $85 hourly Overview This role will lead the Regulatory Operations - Documentation Specialist team in overseeing the documentation processes within an… more
- Trinity Health (Livonia, MI)
- …role model by demonstrating desirable practice behaviors.Assists the System Office Clinical Documentation Manager with all aspects of the CDI program across ... Day Shift **Description:** **POSITION PURPOSE** Work Remote PositionProvides remote clinical documentation integrity (CDI) support to the Health Ministry (HM) CDI… more
- Trinity Health (Livonia, MI)
- …role model by demonstrating desirable practice behaviors. Assists the System Office Clinical Documentation Manager with all aspects of the CDI program across the ... Type:** Full time **Shift:** **Description:** **POSITION PURPOSE** Provides remote clinical documentation integrity (CDI) support to the Health Ministry (HM) CDI… more
- Baptist Memorial (Southaven, MS)
- …as a resource to the coding staff. Reports to the Corporate Clinical Documentation Manager . Performs other duties as assigned. Responsibilities + Facilitates ... Overview Job Summary Evaluates the day to day documentation practices of the Medical Staff and healthcare team on a complex patient population, and offers education… more
