- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of a team of GLLs, manage, develop prepare and implement regulatory documents (eg, draft launch labeling, USPI, annotated labeling, medication guides, EU SmPC, ... through oversight of a team of GLLs, prepare labeling documents for review. Lead review processes to ensure appropriate...development and approval of US, EU and global CCDS documents for regulatory filings and HA labeling discussions. Collaborate… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Contract Coordination: Collate exhibits to create contract draft, Review contract documents for completeness and accuracy; Ensure compliant routing of contracts for ... the audit requirement and processes, storage of critical procurement documents are required to be Inspection ready at all...required to be Inspection ready at all times; these documents must be clearly filed and retrievable. Perform quality… more
- Merck & Co. (Rahway, NJ)
- …The disclosure team works collaboratively and independently to prepare disclosure documents for clinical studies in all therapeutic areas. - The Specialist ... designation. Preparing study registration and results postings based on source documents (eg, protocols, CSRs), negotiating content with internal and external… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …plans, and regulatory submissions/ applications Analyzes proposed study plans and related documents for their ability to deliver the information required by the ... audience Collaborates with others to develop key messages for complex clinical/regulatory documents Authors, reviews and/or edits documents to support clinical… more
- Catalent (St. Petersburg, FL)
- …responsible for the overall Quality Assurance review and approval of all technical documents including but not limited to: a) change controls and associated Master ... documents , including but not limited to Master Batch Records;...Product Development Projects; c) Stability Protocols and cleaning validation documents ; d) Deviations, Laboratory Investigations and other ad hoc… more
- FlexStaff (Nassau County, NY)
- …as appropriate; assesses level of pain and pain management.3.Communicates and documents patient's physiologic health status and plan of care.4.Assesses patient's ... requirements to reduce anxiety and ensure patient satisfaction. Communicates and documents psychological status and care plan of support groups, counseling services,… more
- FlexStaff (New York, NY)
- …plan of care, as appropriate;Assesses level of pain and pain management;Communicates/ documents patient's physiologic health status and plan of care.*2. Assesses ... requirements to reduce anxiety and ensure patient satisfaction;Communicates and documents psychological status and care plan; support group, counseling services,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …products. This position drives/leads the maintenance of global labeling and associated documents (including cartons and external packaging in the US) for assigned ... EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI, annotated labeling, medication guides, EU SmPC, PIL, CCDS).… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Development. Essential Functions Authors, edits, and provides QC review of documents to support clinical trials and regulatory submissions, which may include: ... Drug applications Breakthrough Therapy Designation requests Clinical summary and overview documents in eCTD format for global regulatory submissions Shares knowledge… more
- Insmed Incorporated (Bridgewater, NJ)
- …pharmacology and toxicology studies, author nonclinical sections in regulatory submission documents , and address regulatory inquiries. This position is located at ... Program and Clinical/Regulatory strategy. Author nonclinical sections in regulatory submission documents (eg, IBs, INDs, CTAs, NDAs, BLAs, MAAs, PIPs, Scientific… more
- Insmed Incorporated (Bridgewater, NJ)
- …but not limited to, review and approval of relevant CSV documents .ResponsibilitiesManages direct reports including project assignments, team role assignments, formal ... lab consumable purchases. This will include authorship, review, and approval of technical documents such as qualification protocols and SOPs as well as the design… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to relevant stakeholders Identifies, interviews, and coordinates collection of documents from employees, clients, and relevant stakeholders for litigations, ... government investigations, and subpoenas Oversees production and organization of documents internally and with outside counsel in connection with litigations and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Oversee the CRO and provide timely input to ensure that the CRO-generated documents are created in a timely manner (communication plan, site monitoring plan, etc) ... coordinate with functional group to ensure that essential site documents are collected and sites are initiated per plan....oversight of the transmittal of trial and site level documents to the Daiichi Sankyo Document Control Center (DCC)… more
- Aequor (Athens, GA)
- …& Responsibilities: Complies with applicable regulations and company policies. Documents and maintains records of animal care, preventive medicine, USDA-required, ... and study protocol-driven documents . Provides animal husbandry and care including provision of...accordance with study protocols. Records all scientific information on documents provided with study protocols or standard department forms… more
- LC Staffing (Belgrade, MT)
- …maintenance and control of the company's Quality Management System controlled documents and records. This position interacts with employees throughout the company ... creation, producing hard copy materials for approval signatures, finalization of documents , creating compare-result documents , and making documents … more
- Insmed Incorporated (Bridgewater, NJ)
- …plans of treatment for the HS indication. Tasks include preparing clinical documents (eg protocol, study report, NDA documents ), providing medical oversight ... program level medical oversight of information included in regulatory documents including clinical sections of IND submissions, IND Annual Updates… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for upholding a strong commitment to confidentiality and routinely handles sensitive documents that may impact multiple Global organizational units or Global project ... to the teams for awareness.- Creates and proofs packets of information; develops documents and materials for meetings and a wide array of audiences- Edits and… more
- Insmed Incorporated (Bridgewater, NJ)
- …supporting clinical dose selection and authoring summary and regulatory submission documents . The clinical pharmacologist will work in collaboration with various ... facilitate clinical study design and support regulatory submissionsAuthor regulatory summary documents , such as briefing documents , IND, NDA, etc., and… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …protocol deviation logs.Assists with study materials such as informed consent documents , recruitment materials, case report forms, test article logs, and enrollment ... logs. Orders and maintains research supplies, compiles research charts, prepares source documents , and related duties. Organizes data for the preparation of project… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Target Product Profile (TPP)- Development of clinical sections of trial-level regulatory documents (eg, response to HAs, briefing book, etc.) in conjunction with ... Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety-related documents , in collaboration with the Safety Physician- Maintain up-to-date knowledge of… more
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