- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of (mAb, Drug Substance, Drug Product, or New Modality) for investigational and commercial drugs to the sites of manufacture, both internal and external to Daiichi ... Support the compilation and technical review of relevant CMC sections of regulatory submissions (INDs/IMPDs, NDAs, BLAs, etc.), responses to regulatory … more
- Insmed Incorporated (Bridgewater, NJ)
- …in Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , HCP Marketing will be a key member of the ... ongoing growth of our culture. This position will report to the Senior Director , HCP and Payer Lead. This position does not have any direct… more
- Merck & Co. (Rahway, NJ)
- …reliance on automation within Biologics Process Research & Development (BPR&D).The Associate Director role-will provide process automation leadership within the ... GMP, and data integrity regulations to ensure compliance with regulatory requirements.Develop and maintain SDLC documentation.Actively work in a multi-discipline… more
- Merck & Co. (Rahway, NJ)
- …Quantitative Pharmacology and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global Clinical ... of drug development and effective communication skills. As a subject matter expert, the Associate Director within the QP2-IO Group will work closely with teams… more
- Merck & Co. (Rahway, NJ)
- …of decision-making at our company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate ... on a continuous basis in decision making and driving pipeline impact. The Associate Director will perform job duties independently with minimal supervision… more
- Merck & Co. (Rahway, NJ)
- …completion of carefully designed clinical trials is critical to drug development.The Associate Director , Clinical Trials Communications role within our Research ... vendor invoices and monthly billing packages.Manage/support health literacy and legal/ regulatory /compliance reviews.Serve as liaison with patient advocacy group and… more
- Merck & Co. (Rahway, NJ)
- …full integration of the device development activities with the clinical, regulatory , formulation, commercial and other key company functions.Represent Device ... products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead cross-functional… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …focusing on optimizing patient care and support. Relationships Reports to the Director of PSP Analytics and Ops Excellence. Key internal relationships include ... commercial insights and analytics, Privacy, Legal, Compliance, marketing, Market...support programs data strategy aligns with organizational goals and regulatory requirements, working closely with key stakeholders to drive… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …safety, manage our supply chain and sampling, support technology, provide commercial operations, insights & analytics, maintain our facilities and assure the ... independently in order to accomplish objectives. Relationships Reports to the Director , Patient Support Programs Rare Disease. Key internal relationships include… more
- Merck & Co. (Rahway, NJ)
- …produce safe, effective, innovative medicine.The Global Clinical Data Standards Vocabulary Specialist, Associate Director , is a subject matter expert in CDISC ... Specialist maintains knowledge of new technologies, clinical study data standards, regulatory requirements emerging in industry, and our company's guidelines and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …affiliate, and/or in collaboration with global colleagues. Relationships Reports to the Associate Director Product Quality. Regularly interfaces with multiple NN ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Quality departments. Additional regular stakeholders include NNI Commercial business unit. Drives and maintains positive rapport and… more
- Bristol Myers Squibb (Madison, NJ)
- …lives. Read more: careers.bms.com/working-with-us . **Summary:** The role of Associate Director of US Commercial Regulatory Affairs requires the ability ... to apply complex scientific and expert regulatory advice and risk assessment for the development of...regulatory advice, risk assessment and mitigation strategies to Commercial Teams, Medical Affairs, Public Affairs, Value Access and… more
- Ascendis Pharma (Princeton, NJ)
- The Regulatory Affairs (RA) Associate Director , Labeling will be responsible for labeling activities across programs and stages of development, with specific ... for regulatory submissions and product maintenance. The Associate Director prioritizes their own work to...development . Ability to interact cross-functionally with members of commercial , legal, safety, medical, and others . Proficient in… more
- Novo Nordisk (Princeton, NJ)
- …lives for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide ... Relationships Develop and maintain positive rapport and working relationships with Regulatory Affairs, Legal, Commercial , and other cross-functional stakeholders… more
- Sanofi Group (Bridgewater, NJ)
- The Associate Director RA serves as the regulatory lead on Review Committees (RCs). As the RC RA representative, work with brands on competitively ... promotion of prescription drugs, biologics, and devices. **ESSENTIAL FUNCTIONS** + Provide regulatory leadership and guidance to Commercial teams during the… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … commercial activities to US regulatory agencies. You will manage the commercial regulatory strategy and execution of such for one or more high-volume ... work of one or more direct reports. You will represent the commercial regulatory perspective at and chair high-volume Promotional Review Committee (PRC) meetings… more
- Sanofi Group (Bridgewater, NJ)
- …internal business partners, including but not limited to the clinical development teams, commercial and Global Regulatory Team for assigned projects + Liaises ... **Main responsibilities:** + Leads the US regulatory activities. + As a key member of...with clinical, commercial , and other internal business partners in partnership with… more
- Sanofi Group (Bridgewater, NJ)
- …internal business partners, including but not limited to the clinical development teams, commercial and Global Regulatory Team for assigned projects + Liaises ... team** The team is involved in developing and executing regulatory strategies for Tzield in life cycle development stages...with clinical, commercial , and other internal business partners in partnership with… more
- embecta (Parsippany, NJ)
- …our social channels on LinkedIn , Facebook , Instagram and Twitter . As the Associate Director of Customer and Commercial Operations at embecta, you will ... steward of fees, rebates, chargebacks, and customer master data within our commercial operations. Your role will be pivotal in ensuring accuracy, efficiency, and… more
- Bristol Myers Squibb (Trenton, NJ)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . ** Associate Director , Clinical Nurse Consultant** _The Clinical Nurse Consultant ... (CNC) Associate Director is the leader of a...nurses who function as an extension of the US Commercial organization._ _The CNC- Associate is responsible for… more
