- Novo Nordisk Inc. (Atlanta, GA)
- …and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) principles and tools; executes activities ... a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety , rights and wellbeing; data reliability; scientific… more
- Merck & Co. (North Wales, PA)
- …for the position:Serve as a statistical representative and core member in the Risk Management Safety Teams.- Lead and provide statistical support ... design and statistical analysis methods fundamental to effective pharmaceutical R&D.- The Clinical Safety Statistics (CSS) group within BARDS supports proactive… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with disabilities. Summary This position supports proactive safety surveillance and risk management for assigned clinical studies in partnership with ... (SME) Involved in audits/inspections for safety surveillance and risk management for assigned clinical studies, through inspection readiness preparation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Data Management , Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/ Risk Management , ... of Daiichi Sankyo (DS) in the US, EU, Japan, and other global sites. These business functions include: Clinical Operations, Clinical Development, Biostatistics… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … safety surveillance and risk management , and provide safety leadership including but not limited to clinical studies, post-marketing surveillance, ... centered around rare diseases and immune disorders.Summary The Director, Clinical Safety , will be a product ...topics, and regulatory submissions. This individual will ensure proactive safety monitoring and risk management … more
- Merck & Co. (Rahway, NJ)
- …biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply manufacturing facility in Rahway, New Jersey.The Process Engineer ... will serve as a leader in the FLEx Oral Solid Dosage GMP Clinical Manufacturing facility. --This role will support formulation and process development, scale-up… more
- Merck & Co. (Rahway, NJ)
- …or manager.Requires strong understanding of local regulatory environment.Ability to proactively develop risk management and mitigation plans in the country and ... team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. Summary Position supports safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, ... Safety Expert - Risk Mitigation & Communication: Communicates any safety concerns to management and relevant team members.Reports and Submissions: May… more
- Merck & Co. (Rahway, NJ)
- …team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of ... and pipeline products to produce safe, effective, innovative medicine.The Global Clinical Data Standards Vocabulary Specialist, Associate Director, is a subject… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Clinical representative of executive teams including, the Quality Counsel, Executive Safety Committee, GxP Risk Management Team, applicable CRO/vendor ... Domestic and international clinical trial execution experience required Post-approval clinical management experience a plus Direct management experience… more
- Insmed Incorporated (Bridgewater, NJ)
- …will be responsible globally for executing the safety and risk management activities for one or more clinical development or marketed products throughout ... the benefit- risk documents for assigned products and development compounds. Develops Safety Management Plans. Directs the compilation and interpretation of … more
- Tris Pharma (Monmouth Junction, NJ)
- … reports, periodic safety reports, signal detection activities and risk management planning. The incumbent works cross-functionally with counterparts/teams ... technical and leadership responsibility Current leadership and oversight experience for global safety activities, operations and risk management strategies… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Specialist, Environmental, Health, and Safety (EHS) As a member of the Site Environmental, Health, and Safety (EHS) team, ... EHS. Partners with key stakeholders in research (labs and pilot plants), clinical manufacturing, office, and facility support functions to develop EHS priorities to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for the end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs ... in working in a fast-paced environment, continuous improvement, project management , change and risk management ....and industry standard data collection practices preferred- 7+ years Clinical data management experience in a medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …known for accelerated development and approval with smaller numbers of subjects exposed, Clinical Safety and Pharmacovigilance (CSPV) must be embedded in R&D as ... and during post marketing. Serve as a bridge to Nonclinical Development on clinical safety findings, particularly ones likely to require additional nonclinical … more
- Merck & Co. (North Wales, PA)
- …team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of ... for the operational planning, feasibility, and execution of a clinical protocol.- May lead team in key study planning,... trial team (CTT) lead. -Leads team for timeline management , risk identification and mitigation, issue resolution.-… more
- Merck & Co. (North Wales, PA)
- …SRD development and/or updates to support addressing MIRs.Actively contact and interact with Risk Management Safety Team(s) when required.Act as SME for ... adequate integration of data and scientific evidence with patient safety and clinical relevance elements in a...that the nature of the role presents an increased risk of disease transmission.Current Employees apply HERE Current Contingent… more
- Merck & Co. (Rahway, NJ)
- …Executive Director, as a senior member of the Global Regulatory Affairs and Clinical Safety : Chemistry, Manufacturing and Controls Organization (GRACS CMC), will ... team responsible for a group of products and includes pre-approval regulatory work ( clinical and marketing applications such as IND, CTA, NDA, and MAA) and… more
- Merck & Co. (Rahway, NJ)
- …closely with team members and partner groups including formulators, engineers, Quality, Safety , and Facilities management to drive overall success and ... Job DescriptionPharmaceutical Operations and Clinical Supply is seeking highly motivated individuals for...and processes . - Attends and actively participates in safety , quality, and process improvement initiatives to enhance flexibility,… more
- Catalent (San Diego, CA)
- …Label Control, including review, release and approval process. Site Change Control/ change management programs. Site Risk Management . Site Supplier ... deviations, investigations, CAPAs (corrective and preventative action), supplier scorecards, safety measures, and cost reductions. Clinical packaging experience… more
