- Merck & Co. (Rahway, NJ)
- Job DescriptionRole Overview:The Senior Packaging Scientist, an individual contributor within the Animal Health Pharmaceutical Sciences department, will leverage ... per regulatory agencies, including but not limited to package quality , functionality, extractables/leachables, child resistance, tamper evidence, and shipping… more
- Merck & Co. (Durham, NC)
- …Durham team is seeking a highly motivated individual to serve as a Senior Operations Specialist within the Operations Manufacturing Support team. -In this role, you ... -This role requires the ability to distill large quantities of complex data into simplified reporting and actionable measures, strong problem-solving skills, rapid… more
- Merck & Co. (North Wales, PA)
- …ensuring that project plans are executed efficiently with timely and high quality deliverables. For assigned projects the position serves as the statistical ... programming point of contact and knowledge holder through the entire product lifecycle. Primary Activities :Effective analysis and report programming development and… more
- Merck & Co. (Rahway, NJ)
- …position of Director, Small Molecule Development within the Mixed Modalities, Sterile Product Development (SPD) team. The successful candidate will be expected to ... synthetic modality pipeline.The Director will report to the Executive Director of Sterile Product Development - Mixed Modalities, and lead a team comprised of 10-15… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and executing post-approval Regulatory CMC strategies, reviewing CMC information and data , authoring CMC submissions, and interacting with Health Authorities to meet ... Supplements (PAS, CBE-0, CBE-30), Annual reports, Lot Distribution Reports, Biological Product Deviation Reports, and Drug Listings. Ensures that CMC documentation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....PositionThe Novo Nordisk Real World Evidence (RWE) / Clinical Data Science & Evidence (CDSE) - Fellow is responsible… more
- Tris Pharma (Monmouth Junction, NJ)
- …supports, oversees and manages the Quality Assurance (QA) Investigations and Product Quality Complaints Team to ensure manufacturing quality controls ... Corrective and Preventative Actions (CAPAs) and Continued Process Improvements (CPIs), Product Quality Complaints (PQC) documentation, compliance efforts, … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is ... evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Management, Biostatistics, Non-clinical, Medical Affairs, Marketing, Legal, Quality , and other affiliates. External stakeholders include Healthcare professionals, ... and post-approval phases Perform ongoing and systematic surveillance of all accessible data within allocated product area(s), takes initial actions to mitigate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CAPA plan is followed on rigor as per defined in the internal procedures.- Product Data Management: Responsible to collect and/or evaluate data information ... program and the relationship with contract organizations. Collect, conduct and evaluate data for critical operations related with Annual Product Reviews. Manages… more
- Merck & Co. (Rahway, NJ)
- …responsibilities include, but are not limited to:-IP Application Administration Product owner and application administrator of the cloud-based IP management ... test and provide training for database version releases and new features, manage data migration and improvement projects Apply country law updates to the IP… more
- Merck & Co. (Rahway, NJ)
- …and non-oral portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and ... a vision to develop a team, demonstrated leadership skills, sterile product technical & domain expertise, effective communication skills, understanding of regulatory… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Rare Disease 5D Lead will be responsible for developing and implementing a Data , Diagnostics, Drug, Device, and Digital strategy and execution for relevant TAs, ... to life with wrap around solutions, and ensuring the integration of data , digital, devices, and diagnostics into broader healthcare ecosystem to better serve… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our ... cross-functional teams, including marketing analytics, TA marketing leads, Omni-Channel, product communications, medical affairs, market access and policy/advocacy (MAPA),… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our ... to reflect evolving organizational priorities and market dynamics. Partner with product and capability owners to identify and prioritize roadmap initiatives in… more
- Merck & Co. (North Wales, PA)
- …REGULATORY CMC Biologics (R5)Under general supervision of an Executive Director/ Senior Director, the Principal Scientist /Director is responsible for developing ... and Controls (CMC) regulatory strategies for our organization's biologics product franchises in accordance with domestic and international regulations and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our ... navigating the evolving landscape of healthcare and technology integration. This is a senior level strategic thinker who is leading a complex role in understanding… more
- Merck & Co. (Rahway, NJ)
- …between formulation composition, process and stability of drug substance and drug product to ensure robustness, as well as interrogating the higher order structure ... responsibilities include authoring technical reports and regulatory documents, presenting technical data , and project management. You will serve as a senior… more
- Merck & Co. (Rahway, NJ)
- …solving.Background in Analytical Methodologies and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and ... our company's research facility. The Principal Scientist is a senior scientific role tasked with working closely with the...testing of clinical trial material and in support of product and process development.A strong team player with excellent… more
- Merck & Co. (Rahway, NJ)
- …identify key biopharmaceutics risks at each stage of drug product development for small molecules and/or biologics, conducting hypothesis-based assessment ... and Biopharmaceutics, have 8-10 direct reports composed of experienced, senior and associate biopharmaceutic scientists.- The successful candidate will effectively… more
