- Tris Pharma (Monmouth Junction, NJ)
- …We have more than 150 US and International patents (including applications) and have marketed several branded and generic products in the US, have licensed our ... products in the US and international markets, and have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.Our science and technology make us unique, but our team… more
- Tris Pharma (Monmouth Junction, NJ)
- …and authoring residual solvent, elemental impurity and nitrosamine risk assessments, as directed by R&D. The incumbent may also perform additional responsibilities ... including laboratory analyses of raw materials, in-process (IP) testing, finished products (FP), stability (ST) sample testing and analytical instrumentation maintenance and calibration. ESSENTIAL FUNCTIONS Carries out responsibilities in accordance with… more
- Tris Pharma (Monmouth Junction, NJ)
- …in accordance with company policies, SOPs and state, federal and local laws Performs routine calibration and instrument performance verification, maintenance and ... repairs on highly complicated instrumentation such as HPLC/UPLC, GC, UV-Vis, FTIR, Muffle Furnace, Viscometers, Density Meters, Melting Point, Dissolution and Autosampler, Polarimeter etc.; Performs routine daily calibration/verification checks for balances,… more
- Tris Pharma (Monmouth Junction, NJ)
- …in the pharmaceutical or biotechnology industry. Special knowledge or skills needed and/or licenses or certificates.Thorough knowledge of Good Clinical Practices ... (GCPs), International Conference on Harmonization (ICH) guidelines and regulatory requirements for clinical trial managementWorking knowledge of Electronic Data Capture (EDC) systems (ie, Inform, Medidata, TrialMaster, etc.)Medical writing experience authoring… more
- Tris Pharma (Monmouth Junction, NJ)
- …Licensing - Assists with state licensing and compliance requirements, including preparing and filing necessary documentation Intellectual Property (IP) - Manages ... company's intellectual property portfolio, including trademark and copyright filings and renewals Sunshine Act Reporting - Prepares and submits Sunshine Act reports in a timely and accurate manner Contract Support - Reviews and analyzes contracts, agreements… more
- Tris Pharma (Monmouth Junction, NJ)
- …include, but are not limited to: medical analysis and decision making for the development of ad hoc aggregate safety reports, periodic safety reports, signal ... detection activities and risk management planning. The incumbent works cross-functionally with counterparts/teams in Clinical Development, Regulatory Affairs, Manufacturing, Quality, etc. to identify, evaluate and communicate safety observations. The incumbent… more
- Tris Pharma (Monmouth Junction, NJ)
- …We have more than 150 US and International patents (including applications) and have marketed several branded and generic products in the US, have licensed our ... products in the US and international markets, and have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.Our science and technology make us unique, but our team… more
- Tris Pharma (Monmouth Junction, NJ)
- …We have more than 150 US and International patents including applications and have marketed several branded and generic products in the US, have licensed our products ... in the US and international markets, and have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology. Our science and technology make us unique, but it is our team… more
- Tris Pharma (Monmouth Junction, NJ)
- …compliance with all SOPs, cGMP, FDA, as well as all applicable company compliance guidelines, standards and objectivesOversee and manage the maintenance and tracking ... Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company in the US with a focus on development and commercialization of innovative medicines that address unmet patient needs. We have more than 150 US and International… more
- Tris Pharma (Monmouth Junction, NJ)
- …in compliance with all cGMP, FDA, DEA, and OSHA regulations, as well as all applicable company compliance guidelines, policies, standards and objectives.Sets up and ... operates analytical instruments including (but not limited to) HPLC, GC, UV/Vis, Automatic titration, IR, AA, TLC and dissolution apparatus to support sample testing.Performs laboratory analyses of raw materials, in process (IP), finished products (FP) and… more
- Tris Pharma (Monmouth Junction, NJ)
- …across the deal process including identification of opportunities, evaluation from a strategic, commercial, scientific, and financial standpoint, and execution (due ... Tris Pharma, Inc. ( www.trispharma.com ) is a leading privately-owned biopharmaceutical company in the US with a mission to develop and commercialize innovative therapeutics that address unmet patient needs. Our core focus is CNS, with a marketed portfolio of… more
- Tris Pharma (Monmouth Junction, NJ)
- …(www.trispharma.com) is a leading privately-owned biopharmaceutical company in the US with a focus on development and commercialization of innovative medicines that ... address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in the US, have licensed our products in the US and international markets, and have a robust pipeline… more
- Tris Pharma (Monmouth Junction, NJ)
- …Processes daily order demand and releases and other daily interactions with a third-party logistics provider. Handles all customer service requests. Handles and ... oversees data flows (ie, Sales, Chargebacks, Electronic Data Interchange (EDI) reports, etc.); assists in tracking sales and performance to budget. Assists with analysis and reporting of sales and inventory trends; gathers and analyzes data for potential new… more
- Tris Pharma (Monmouth Junction, NJ)
- …Responsible for all aspects of Packaging equipment maintenance in accordance with company policies, SOPs, cGMPs and FDA requirements Performs packaging line change ... overs and startups Assists Packaging Operations/Quality Assurance (QA) activity during the running of packaging lines Performs routine and complex work related to the troubleshooting, repair, and upgrade of all packaging equipment including but not limited to:… more
- Tris Pharma (Monmouth Junction, NJ)
- …in accordance with the organization’s policies, SOPs, and state, federal and local laws Performs testing of raw materials, IP, FP and/or ST samples including ... Founded in 2000, Tris Pharma, Inc. (www.trispharma.com) is the 3rd largest, private specialty pharmaceutical company in the United States. With our intense focus on application of physical chemistry in the biological systems, coupled with the requirements of… more
- Tris Pharma (Monmouth Junction, NJ)
- …(PQ) studies for Equipment Qualifications Performs and assists with other Validation tasks and activities as instructed by TS Engineers and/or management Adheres to ... Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company in the US with a focus on development and commercialization of innovative medicines addressing unmet patient needs. We have more than 150 US and International patents… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Bachelor's degree required MBA required Minimum of 10 years of industry or M&A experience required PMP or equivalent training preferred Doctoral degree (PharmD, PhD ... or MD/DO) preferred Relevant experience includes: Proven ability to build strong collaborative relationships Cross-functional experience in multiple functional areas Ability to manage multiple projects and engage stakeholders in a dynamic environment with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …A Bachelor's degree required, advanced degree preferred A minimum of ten (10) years of progressively responsible clinical trial experience within a pharmaceutical, ... biotechnology, or CRO required, Training & Development or Operations experience preferred Three (3) or more years of Managerial experience required Knowledge and understanding of FDA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …MD required Additional MBA preferred Minimum of 5 years of clinical and/or prior direct patient care experience required Relevant experience includes: Proven ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …A high school diploma or GED required A minimum of 2 years administrative or related experience required Ability to handle multiple priorities and demands Ability to ... interact with all levels within the organization Ability to work in a fast-paced environment Demonstrated customer service skills Has the ability to work under general supervision Requires a sound substantial understanding of general office routines and… more
