- Genmab (NJ)
- … data standards (eg, CDISC/CDASH).Excellent cross-functional communication and project management skills.Experience supporting regulatory filings and ... Data Quality Management , is a strategic leadership role within Clinical Data Management . This individual is accountable for driving the strategy, quality,… more
- Merck & Co. (Rahway, NJ)
- …- Strong analytical skills and experience and be results-oriented. Project and Change Management - Strong project management skills and a proven ability ... deliverables.A close partnership and working relationship with the Global Category Manager , Global Program Management , regional operations teams, stakeholders… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …maintains positive relationships with internal/external stakeholders/vendors/partners. Project Management : - Accountable for completion of laboratory data ... skills in working in a fast-paced environment, continuous improvement, project management , change management , and...requirements to DM standards teams and program teams.- Advise Manager , Laboratory Data Management on… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …correspondence May act as GRT member Oversight of annual reports Participate in project team meetings as assigned Review data from contributing departments ... regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The… more
- Twist BioScience (South San Francisco, CA)
- …ethic, commitment to the highest quality of workProficient with project management tools and applications (such as Smartsheets/Asana/JIRA/Confluence)Preferred ... Staff Program Manager (Hybrid in South San Francisco, Portland, OR...development and manufacturing activities is a plus.PMP or similar project management certification is a plus.Experience with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …think creatively to solve Outstanding team- and client-facing communication skills Project management skills Quantitative analysis skills Statistical programming ... on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring...ready to experiment with us? The Position The Senior Manager - Market Access Insights works with the Director… more
- Genmab (NJ)
- …leading the programming efforts of at least one study are in scope.The Programming Manager will support the Data Management , Statistics, Drug Safety, ... we would love to have you join us!The Programming Manager supports the development of new therapies by ensuring...of data consistenciesSupports specification and pooling of data across clinical trials within the same project… more
- Merck & Co. (Boston, MA)
- …Quantitative systems pharmacology, Model-Based Drug Development-, or scientific data management .Experience leading cross-functional teams, launching, and ... (RaDS) value team in R&D IT brings together product management , engineering, and data science expertise. We...time management skills as well as demonstrated project management ability.Excellent written and oral communication… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... Novo Nordisk requirements in relation to Pharmacovigilance (PV) oversight and deviations management . This role fulfills the PV Oversight function in PV deviation … more
- Twist BioScience (South San Francisco, CA)
- …as phage, ribosome or yeast required.Extensive use of scientific databases and applications for data management and data analysis, including, but not limited ... Manager , In vitro Discovery (South San Francisco)We are...Will manage all activities of the team and key project deliverables in area of responsibility.Help train and supervise… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …project timelines and resource planning, work in tandem with Biostatistics and Data Management members to ensure best vendor performance, monitor analysis ... Form (CRF) annotation and Study Date Tabulation Model (SDTM) dataset, identify data inconsistencies and support data review, review analysis dataset… more
- Genmab (NJ)
- …Programming Manager will work with other functions including Data Management , Statistics, Drug Safety, Medical, Clinical Pharmacology,Translational Research, ... Medical Writing, Project management , and Regulatory. Responsibilities/tasks - including...and ADaM database standards. Supports specification and pooling of data across clinical trials within the same project… more
- ACROBiosystems Inc. (San Diego, CA)
- …management skills, with the ability to prioritize tasks and meet deadlines. Project management experience with the ability to coordinate multiple stakeholders ... collaboration and continuous learning. Job Summary The Regional Marketing Manager will develop, execute, and monitor local marketing strategies across… more
- Aequor (Aliquippa, PA)
- …shipments and quantity discrepancies, including quality record ownership. Ongoing project management focused on continuous process improvement. Provide ... Ensure current Good Manufacturing Practices (cGMP) and Safety compliance. Utilizes project management skills to support Logistic Service Provider (LSP)… more
- Eisai, Inc (Nutley, NJ)
- …development plans within the clinical development. Works with the clinical, project management , and data manager teams on strategic designs of studies; ... as clinical study protocols, statistical analysis plan, CRF, edit check specification, data management plan, final database validations, final study report.… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …PowerPoint, Excel, OneNote, Project , and Teams Requires demonstrated computer skills with data management systems or data bases Ability to utilize ... is responsible for maintaining and advising new projects on the Building Management System while collaborating with the Engineering team to provide necessary… more
- Aequor (Seattle, WA)
- …in support of batch history sections for regulatory submissions.Proficiency in data management /statistical analysis software, including Excel, JMP, and Spotfire ... in support of batch history sections for regulatory submissions. Proficiency in data management /statistical analysis software, including Excel, JMP, and Spotfire… more
- Merck & Co. (Durham, NC)
- …and Word, AutoCAD and Business Objects.. Preferred Experience and Skills: Project management , including change control and equipment qualificationSAP experience ... EXPERTISE: Applies skills to align work activities with department objectivesProject management (manages project priorities - schedule & cost,… more
- Eisai, Inc (Nutley, NJ)
- …maintenance. Ensures programming related technical and end user support to other areas of Data Operations, Data Management , Clinical Safety Data Review ... of the essential Reports Manage the programming for Laboratory data management , conversion, normal ranges, & reconciliationManage Development… more
- Merck & Co. (Durham, NC)
- …environments complying with current Good Manufacturing Practices in the form of project management and ultimately shop floor leadership.- Key Responsibilities ... for a Drug Product Operations Manager Accountability - Project SupportFirst-line operations supervisor...People Management , Process Engineering, Process Improvements, Production Management , Production Scheduling, Project Management … more
