- Daiichi Sankyo, Inc. (Bernards, NJ)
- …assigned GMA plan activities, in collaboration with Sr Director.- Support medical readiness activities for market launches and life cycle management for select ... indications/projects. Gains strategic and planning alignment across regions and functions and supports review of Local Country/Regional Medical Affairs activities when applicable. Provide medical support/input into commercial and market access discussions for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …project initiatives.Supports any business improvement efforts.Supports permanent inspection readiness and actively supports internal audits and regulatory ... inspections.Provides input to studies related to process improvement and implementation of new manufacturing technologies and associated protocols.Provides input and supports improvements related to the aseptic environment and technique.Job duties performed… more
- Merck & Co. (Rahway, NJ)
- …from concept generation/selection, development, verification, and validation to launch readiness :Lead the cross-functional Device Working Groups to ensure full ... integration of the device development activities with the clinical, regulatory, formulation, commercial and other key company functions.Lead the Device Development Engineering Core teams focused on development of design requirements for the combination product… more
- Insmed Incorporated (NJ)
- …result in manufacturable, scalable, and compliant processes while maintaining supply chain readiness for both clinical and commercial needs. You will support global ... regulatory strategies by contributing to IND filings, BLA submissions, and pursuing orphan and rare disease designations that align with our therapeutic focus areas.A key aspect of your role involves building and mentoring a high-performing product development… more
- Insmed Incorporated (NJ)
- …devices. A critical aspect of this role involves ensuring manufacturing readiness for both clinical and commercial supply chains.Your responsibilities will include ... supporting global CMC regulatory strategies that align with our clinical and commercial objectives. You will author, review, and approve CMC sections of regulatory submissions including INDs, NDAs/MAAs, and other required documentation. Ensuring compliance… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …closure and product release.Support regulatory inspections and audits by ensuring inspection readiness within facility and serving as an SME during the execution of ... regulatory inspections and audits as needed.Support compliance activities for site Quality Operations in accordance with Legend standards, procedures and cGMPs.Collaborate with site personnel to provide guidance and determine resolution for end-to-end… more
- Formation Bio (Boston, MA)
- …across complex multi-entity structures Policy Development, Documentation, and Audit Readiness Authors and maintains the company's technical accounting policy library ... covering key areas of biotech, fund, and investment accounting Implements processes for consistent application of GAAP across entities and transactions Prepares audit-ready documentation packages for all significant judgments and technical positions… more
- Syner-G BioPharma Group (Boston, MA)
- …across facilities.Support business continuity planning and emergency response readiness .QUALIFICATIONS AND REQUIREMENTS: To perform this job successfully, an ... individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, skills, knowledge, and abilities required. Reasonable accommodation may be made to enable individuals with… more
- Novo Nordisk Inc. (Boulder, CO)
- …products at CMO partners. Plan and execute qualification and operational readiness initiatives required to support clinical API internal manufacturing. Coordinate ... with leadership team & other relevant stakeholders to ensure strong communication & aligned priorities on short/medium/long range. Relationships Reports to Corporate Vice President. Essential Functions Serve as key partner for site leadership, managing… more
- Insmed Incorporated (NJ)
- …(P2P) transformation by assisting with data integrity, process analysis, and system readiness efforts as we prepare for the implementation of our new financial ... system. You'll also: Assist with supplier data clean-up, validation, and maintenance to ensure accuracy across procurement and accounts payable systemsConduct data analysis to identify and correct duplicate or inactive supplier records and purchase ordersHelp… more
