- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Vice President, Regulatory Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical ... strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel medicines.Contributing to the continuous improvement of the… more
- Merck & Co. (Rahway, NJ)
- …in Regulatory AffairsNOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this ... Job DescriptionOur Regulatory Affairs team bring new medical advancements to the world by... policy are required to have a minimum of twelve (12) months of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …cross-functional teams, including sales, marketing, medical affairs, market access and policy /advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs, ... group creates and delivers human-centered experiences, where innovation meets customer -centricity, driving the ultimate experience for our patients. Our focus… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... related drug/vaccine projects in Late Development Statistics.Interacts with Clinical, Regulatory , Statistical Programming, Data Management, and our company's Research… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …cross-functional teams, including sales, marketing, medical affairs, market access and policy /advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs, ... the ability to translate insights into actionable marketing strategies to guide customer experiences Strong understanding of regulatory , compliance, and ethical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …group creates and delivers human-centered experiences, where innovation meets customer -centricity, driving the ultimate experience for our patients. Our focus ... our strategies are rooted in a deep understanding of customer needs and behaviors. Our 'test and learn' mindset...area marketing leads, sales, medical affairs, market access and policy /advocacy (MAPA), and channel leads to align marketing tactics… more
- Merck & Co. (Rahway, NJ)
- …and scientists within Discovery, Pre-clinical Development, Manufacturing, Quality Assurance and Regulatory groups and provides technical insights and support for our ... in a timely manner needed to meet project milestones and associated regulatory requirements.- This includes development of novel tools and processes to position… more
- Merck & Co. (Rahway, NJ)
- …CCDS, CCPPI, CCIFU) and US labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance of the EU Labeling and other ... and implementing US Labeling for assigned products in line with regulatory requirements and internal standards and guidelines.- Assisting with developing and… more
- Merck & Co. (Rahway, NJ)
- …Maintains personal awareness of developments in the fields of medical information, regulatory policy , adverse event reporting, information storage and retrieval, ... and interests from the world's biomedical literature in support of regulatory , clinical research, marketing, and legal functions.- Plans, organizes, monitors,… more
- Merck & Co. (Rahway, NJ)
- …bring analytical representation and expertise to project teams and support regulatory filings (eg, INDs/IMPDs and BLAs).-The Director selects, trains, and ... personnel under her/his direction within the framework of Company policy .- The role will also be responsible for proactive...strong network internally and across the external academic and regulatory community is expected, as well as advancing a… more
- Merck & Co. (Rahway, NJ)
- …and sterile products.- It also includes strategic partnering with CMC and Regulatory in aspects of control strategy and filings, Quality, and our partners ... effective technical and communication skills, an effective understanding of the regulatory environment, and a-vision to influence the regulatory … more
- Merck & Co. (Rahway, NJ)
- …packaging, compatibility characterization for processing and administration, and supporting regulatory filings. Have deep fundamental knowledge around large molecule ... development to ensure completion of key milestones and laboratory / regulatory documentation. Active strategic and technical leadership to influence program… more
- Merck & Co. (CA)
- …in Field Sales Teams and play a critical role in supporting our customer centric business model.-As the largest provider of animal identification technology, we meet ... growing customer needs by providing over 500 million tags for...well-being and performance of animals and the people who care for them.The Territory Sales Manager - Livestock ID… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are ... of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Director may be responsible… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... support for translational oncology projects and studies.-Interact with Clinical, Regulatory , Statistical Programming, Data Management, and other company Research… more
- Merck & Co. (North Wales, PA)
- …trial team.Collaborates with the Medical Writer on clinical/scientific and regulatory documents.Partners with Study Manager on study deliverables.Participates in the ... This includes the ability to:Apply strong knowledge of clinical research regulatory requirements (eg, GCP and ICH)Manage multiple competing priorities with good… more
- Eisai, Inc (Nutley, NJ)
- …provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through ... play a pivotal role in ensuring the organization's adherence to security, regulatory , and compliance standards. Collaborating with business and EIT stakeholders, you… more
- Novo Nordisk Inc. (Irvine, CA)
- …the most diverse and collaborative groups within the organization. From health- care -provider interactions and developing and implementing regulatory strategies ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...CMR, International Operations (IO), and HQ R&D). Provides excellent customer service and builds strong working relationships with investigative… more
- Merck & Co. (Rahway, NJ)
- …and characterization, scale-up and activities to support technology transfer and regulatory filings.The CBT group is an interdisciplinary team responsible for the ... supply sites and documented in technology transfer documents and regulatory filing submissions.The individual maintains awareness of external factors, internal… more
- Merck & Co. (North Wales, PA)
- …management and vendor partnersPossesses a strong understanding of relevant regulatory guidelines and compliance requirements pertaining to Medical Affairs ... operations, and, preferably, experience in navigating regulatory challenges associated with digital technologiesExperience in navigating regulatory challenges… more
