- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders. **Summary** The Associate Director of Regulatory Writing is a key role ... and strategic insights at the study team level. The Associate Director of Regulatory Writing...clinical documents + Participate in initiatives within the Global Regulatory Writing Group to identify process improvement… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. **Job Summary:** The Associate Director of Regulatory Writing is a key role ... and strategic insights at the study team level. The Associate Director of Regulatory Writing...clinical documents. + Participate in initiatives within the Global Regulatory Writing Group to identify process improvement… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Associate Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly ... focus on Clinical Regulatory filings and provide regulatory leadership on...US FDA and international pharmaceutical guidance, regulations, drug development process , and industry standard practices. + If you are… more
- Bausch Health (Bridgewater, NJ)
- …your skills and values drive our collective progress and impact. The Associate Director , Advertising and Promotion, Prescription Drug Products, reviews, approves ... drug product advertising and promotional labeling pieces for compliance with regulatory agency requirements. Responsibilities **:** + Provides regulatory review… more
- Novo Nordisk (Plainsboro, NJ)
- …across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential Functions + Serve ... difference? The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational medicines. You… more
- Bristol Myers Squibb (Madison, NJ)
- …others. + Understanding of strategic and tactical role for the drug development process . + Understanding of general global regulatory requirements for drugs in ... development. + Understanding of R&D process and specific regulatory responsibilities/deliverables for the company decision points. **For roles based in… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … improvements or other special projects. May initiate and/or contribute to global process improvements. + Provides regulatory guidance on new marketing concepts, ... their aspirations. Join Gilead and help create possible, together. **Job Description** Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual ... will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive… more
- Bristol Myers Squibb (Madison, NJ)
- …careers.bms.com/working-with-us . **Position Responsibilities** + Develop global and/or US regulatory strategy for Oncology products in development and through life ... company objectives. + Develop strategic direction and provide leadership for all regulatory interactions with FDA/global regulatory authorities + Lead … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...in the development of Standard Operating Procedures (SOPs) and process improvements. Follows agreements with external partners. + Department… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …internally in the kilolab and externally at contract manufactures. + The Associate Director will have organizational and interdepartmental responsibilities with ... and collaborative teamwork. The scientific knowledge package from the manufacturing process , design parameters, and control strategies enables regulatory filings… more
- Bank of America (New York, NY)
- Director , Regulatory Implementation Product Specialist New York, New York **Job Description:** At Bank of America, we are guided by a common purpose to help make ... budgeting, personnel processes, audit/compliance, and coordination of certain projects, associate training, service quality, process improvement, business… more
- Merck (Rahway, NJ)
- **Job Description** Under minimal guidance of the Executive Director / Director / Associate Director , Pharmacovigilance (PV) Partner Strategy & Management ... Company CRO partners and oversight of the PV intake process and collaboration with International PV for management of...and SMPs. + Maintains, in collaboration with the Executive Director / Director / Associate Director … more
- Bristol Myers Squibb (New Brunswick, NJ)
- …personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Associate Director - Site Planning Global Process Leader (GPL) will be ... ini t iatives . Lead the delivery of , digital first , process enhancements to continuously improve core pillar capabilities that will drive enterprise performance… more
- Merck (Rahway, NJ)
- **Job Description** **Position Description:** ** Associate Director , Policy Advocacy** The Associate Director , Policy Advocacy serves as the senior expert ... in advancing policy change in support of the company's business objectives. The Associate Director will proactively research and stay abreast of new strategies… more
- Merck (Rahway, NJ)
- … Director to the GPP leadership as requested. The Associate Director will also coordinate the process of developing and updating public-facing policy ... **Job Description** **Position Description:** ** Associate Director , Policy Strategy and Capabilities**...positions, and initiate other process improvements to strengthen strategic planning and policy development… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- We are seeking an Associate Director to join out Oncology Clinical Development department. The Associate Director Clinical Sciences leads in the ... scientific integrity and interpretation of study data of a clinical development program. The Associate Director leads in a matrix environment as part of a… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- We are seeking an Associate Director to join our Clinical Development team. The Associate Director Clinical Sciences leads in the development, ... of study data of a clinical development program. The Associate Director leads in a matrix environment...skills. We are seeking proficient knowledge of clinical development process , regulatory requirements and ICH/GCP guidelines. Does… more
- Bristol Myers Squibb (Summit, NJ)
- …personal lives. Read more: careers.bms.com/working-with-us . **Title: Sr. Manager / Associate Director , Global Sterility Assurance CTTO** **Location: Seattle, ... BMS with our Cell Therapy team. T he **Sr Manager/ Associate Director - Sterility Assurance, Cell therapy...also provide guidance and support for all aspects of regulatory submission, inspections, IR responses process , equipment… more
- RiseBoro Homecare Inc. (Brooklyn, NY)
- …position and additional preferred qualifications will be considered. Purpose of Position: The Associate Director , Home Delivered Meals is a member of the ... Director of the Home Delivered Meals Program. The Associate Director is responsible for managing a...policy and procedures as well as the following partner regulatory agencies: Department of the Aging (DFTA), City Meals… more