- Organon & Co. (Jersey City, NJ)
- …**The Position** Individual contributor responsible for ensuring that all Organon products managed by External Quality Assurance (EQA) are manufactured, packaged, ... analyzed, released, stored, and distributed in accordance with Organon expectations and all applicable regulatory requirements. The External Systems Quality Leader (ESQL) serves a leadership role in the management and oversight of contract manufacturer… more
- Bristol Myers Squibb (Princeton, NJ)
- …Within a specific therapeutic area of Dermatology and Rheumatology: + Provides scientific and clinical input into the development of disease strategy, the development ... of marketed and/or early compounds and into the commercial organizations + Contributes to the Medical Plan development and execution + Provides strategic insight into launch activities planning, and executes pre-launch, peri-launch and post-launch tactics +… more
- Bristol Myers Squibb (Princeton, NJ)
- …+ Develops and executes translational disease strategy in Alzheimer's /Neurological disease areas with deep disease expertise + Leads and oversees execution of ... disease strategy including but not limited to various aspects of patient selection strategies + Serves as scientific expert in generating novel hypotheses for targetable biologies based on novel discoveries integrating disease work with literature and deep… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …**Data Integration & Management** + Explore and analyze common pharmaceuticals data (eg, claims) as well as novel data sets based on lab and EHR systems. Work with ... Omnichannel Data Engineer to Integrate data from multiple sources (eg, CRM systems, social media, email platforms) to create a unified view of stakeholder interactions. + Apply natural language processing (NLP) to extract insights from unstructured medical… more
- Bristol Myers Squibb (Princeton, NJ)
- …+ Independently engages as a business partner to the Oncology Global Commercial Strategy team for ongoing commercialization + Earns status as a trusted advisor, ... embedding customer and market insights into business decision making + Partners with key stakeholders within the Oncology Global Commercial Strategy team to support strategic and tactical commercial decisions through: Market Research, Forecasting, Secondary… more
- United Therapeutics (Trenton, NJ)
- …+ Proficient knowledge of FDA regulations, including 21 CFR 1271 and 21 CFR 312 **Job Location** This role is located onsite in our Eden Prairie, MN (Miromatrix) ... location with the option for a remote candidate with monthly travel if they have 1271 or CBER experience. The salary for this position ranges from $165,000 to $225,000 per year. In addition, this role is eligible for the Company's short-term and long-term… more
- BeOne Medicines (Pennington, NJ)
- …Responsible for the design, implementation, and management of Compliance programs for the Hopewell, NJ site. Programs which require development under the QMS include, ... but are not limited to market action, self-inspection, Health Authority inspection preparation, annual reporting, deviation/complaint/CAPA management, and vendor qualification. This position also includes successful day to day management of these systems post… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …You will act as the Regional Regulatory Lead on more complex or multiple products, compounds, indications or projects in the assigned therapeutic area. You will ... typically be assigned multiple products or projects to lead, manage and oversee simultaneously. You will define the regulatory strategy, plans and objectives for assigned products or projects. You may act as the Global Regulatory Lead for early-stage or other… more
- Organon & Co. (Jersey City, NJ)
- …**The** **Position** The purpose of the Label Strategist is to drive labeling strategy and provide high quality and compliant labeling documents, ensuring the safe ... and effective use of products for patients and healthcare providers globally. The Label Strategist is accountable for developing and maintaining the target product labeling for developmental products, the core labeling documents (CCDS) and US labeling for… more
- Amneal Pharmaceuticals (Bridgewater, NJ)
- …The Commercial Counsel will be an integral member of the Amneal Legal team and will serve as a trusted legal advisor for all commercial activities involving the ... company's specialty, biosimilar and generic products. The incumbent will serve as a member of Amneal's promotional assets review committee (PARC), draft/review/negotiate general commercial and other types of contracts, and handle market access/customer-facing… more