- Insmed Incorporated (New York, NY)
- …expenses within assigned budget parameters Is accountable for the accurate and timely documentation of all activities This position will be based in New York Metro ... a local medical and scientific resource to Insmed for product planning, clinical insights, and intelligence. Capture, synthesize and deliver HCP derived scientific… more
- Merck & Co. (Rahway, NJ)
- …program cost estimates requested by Product Development Teams.- Responsible for authoring clinical supply documentation in support of labeling and packaging ... Job DescriptionThe Global Clinical Supply organization is accountable for managing the...activities as well as supply chain documentation to support critical Compound Management Coordination activities.- -… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory Affairs & ... Clinical Safety global business processes. This includes defining and...Technology.Develop &/or and manage process related artifacts (process maps, documentation , training content and role identification), ensuring alignment across… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... for a living. Are you ready to make a difference? The Position The Senior Director of CMR Knowledge & Technical Advancement (KTA) Department will serve to act as an… more
- Merck & Co. (Rahway, NJ)
- …Ingredient (API) processes meet target yield, purity, and physical attributes for clinical programs across the diverse pipeline. As a recognized expert in the ... Practices (cGMPs), and participating in risk assessments, and Good Documentation Practices (GDPs).-In addition to supporting pipeline activities, the Crystallization… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary This position works with the Director , Clinical Study Startup to establish the strategy driving global ... where appropriate and escalate any complex problems to the Director , Clinical Study Startup.This position requires strong...Reviews and provides input to SOPs, SOIs, and process guides. Clinical Study Start-Up Documentation : Reviews all … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of safety data between partners in relation to marketed and clinical products.Strategic Partner Management:Oversees Local/Global PV service providers responsible for ... with key stakeholders within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs. Facilitate operational meetings… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data ... EU. Preparation of updated Core Data Sheets, and EU and US Documentation : Independently manages, prepares and implements regulatory documents (eg, USPI, annotated… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global sites. These business functions include but are not limited to Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory ... Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in other DSI governance process (DRF, G-PAD, GROC, GRSC etc.) Interfaces with clinical & pre- clinical groups, Regulatory CM&C and other appropriate group within ... Joint-GPT as applicable.Supervises the identification and compilation of required documentation for submission. Prioritizes workload as necessary.Keeps current with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads ... new and updated Core Data Sheets, EU and US Documentation : As the project lead, Independently or through direction...3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads ... objectives.ResponsibilitiesPreparation of new and updated Core Data Sheets, EU and US Documentation : As the project lead, Independently or through direction of a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for Changes and process improvements.Provide oversight, Manage Implementation and documentation of PV Safety systems Change Request supporting documents and ... a comprehensive understanding of the functional roles within Pharmacovigilance and Clinical TrialsAbility to extract configurable data fields from a study… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(MedDRA and WHO Drug Coding dictionaries) including dictionary support documentation . Collaborates cross-functionally with the Medical, Clinical Development, ... of medical coding services for assigned programs, collaborating with program teams, clinical safety and pharmacovigilance, CROs, and partners to ensure high quality… more
- Merck & Co. (Rahway, NJ)
- …Scientist is a senior scientific role tasked with working closely with the group Director to define group strategy and to lead a team of scientists in solving ... and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process development.A… more
- Win (Women In Need) (New York, NY)
- Title of Position: Clinical Director (LCSW or LMHC) FLSA Status: Exempt Department: Transitional Housing Reports to: Program Director Positions reporting to ... to $90,000 per year Purpose of the Position The Clinical Director is responsible for the programmatic...Conduct audits of the Uniform Client Chart and supporting documentation to ensure compliance with Office of Temporary and… more
- Arms Acres (Jamaica, NY)
- Clinical Director , Queens Jamaica, NY (http://maps.google.com/maps?q=9002+161st+St+Jamaica+NY+USA+11432-6108) Apply Description Are you looking to be a part of a ... will keep us on the cutting edge of Behavioral Health Care issues. The Clinical Director administers and supervises the daily management of the outpatient… more
- Hackensack Meridian Health (Belle Mead, NJ)
- …accordance with regulatory agencies. **Responsibilities** A day in the life of a Director Clinical Social Services at Hackensack Meridian _Health_ includes: + ... and serve as a leader of positive change. The Director , Clinical Social Services is a New...LAC and LSW supervisory sessions as required. Provides necessary documentation for the licensing of each CCM. + Coaches… more
- Legacy Treatment Services (Hainesport, NJ)
- Clinical Director Job Details Job Location Co-Occurring Mental Health/Substance Use - Hainesport - Hainesport, NJ Position Type Full Time Education Level ... Graduate Degree The Clinical Director will lead and oversee the...clinical team, ensuring equitable service delivery. + Proper clinical documentation of screening, assessment, treatment planning,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **Summary** This position works with the Director , Clinical Study Startup to establish the strategy driving global ... where appropriate and escalate any complex problems to the Director , Clinical Study Startup. This position requires...provides input to SOPs, SOIs, and process guides. + Clinical Study Start-Up Documentation : Reviews all … more
