- Merck & Co. (North Wales, PA)
- Job DescriptionUnder general supervision of an Executive Director /Senior Director , the Principal Scientist / Director is responsible for developing and ... implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics product franchises in accordance with domestic and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders.Summary The Director , Head of Global Dossier Planning, Regulatory Operations is responsible for leading the dossier planning team and ... Director of Dossier Planning will ensure high quality regulatory submissions to health authorities including...of Dossier Planning will report to Head of Global Regulatory Operations and be an active participant… more
- Merck & Co. (Rahway, NJ)
- …high- quality data from clinical trials conducted worldwide. In partnership with the Clinical Quality Operations Lead (CQOL) and Head of Clinical Quality ... Operations , the Clinical Quality Operations Manager (CQOM) is accountable for the execution of...well as preparing for, management and follow up of regulatory inspections. Primary Duties: Operational Quality Management:… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Ensure compliance with SOPs, ICH, GCP and other national and international regulatory requirements Work with, Clinical Operations , Non-Clinical Research, Medical ... merges biotech speed and agility with large pharmaceutical company quality , resources , and stability, uniting the best of...you ready to make a difference?The Position The Medical Director serves as the subject matter expert for our… more
- Merck & Co. (Rahway, NJ)
- …and Regulatory in aspects of control strategy and filings, Quality , and our partners in the commercialization and manufacturing division.This challenging ... regulatory environment, and a-vision to influence the regulatory environment.Nature and Scope of Position:The Director ...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Global Development Hub merges biotech speed and agility with large pharmaceutical company quality , resources , and stability, uniting the best of both worlds to ... for the treatment of primary hyperoxaluria. In doing so, the Senior Medical Director will work across different functional teams to support the design and execution… more
- Merck & Co. (Durham, NC)
- …the new HPV vaccine drug substance manufacturing facility. As a direct report to the Director of Operations , the Associate Director will be accountable for ... support to ongoing manufacturing activities. Working Relationships: Reports to the Director of Operations Facilitates Purification Suite leadership team,… more
- Merck & Co. (Durham, NC)
- … quality of raw materials, intermediates and finished products.GENERAL SUMMARY The Director of Operations (Integrated Process Team (IPT) Lead) is an exciting ... Job DescriptionOur Manufacturing Operations teams are the people that make our...work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work… more
- Merck & Co. (North Wales, PA)
- …Management of the Medical Device and Combination Product (MDCP) Quality Assurance Operations team, the Associate Director Quality Engineering & ... to ensure that the testing is sufficient to meet regulatory requirements and quality objectives.Provide input to...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAssociate Director - Digital Forensics Position Summary:-We are seeking a highly skilled and experienced professional to join our team as an Associate ... Director for our Digital Forensics Lab. The Associate ...digital forensics investigations.Key Responsibilities:Laboratory Supervision and Management:-Oversee the day-to-day operations of the digital forensics lab, ensuring all activities… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …standards and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key ... Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, Operations... quality metrics and share with study team, Operations Program Lead, and Sr. Director for… more
- Insmed Incorporated (Bridgewater, NJ)
- …lists.OverviewReporting to the Executive Director Quality GMP Compliance, the Director , Quality Operations will play a key role in managing ... QC oversight activities for Insmed. He/she will be responsible for Quality related activities for commercial products including transition from development (Phase… more
- Merck & Co. (Millsboro, DE)
- …DNREC, etc.) of animal facilities and program reviews is required.PurposeThe Associate Director /Attending Veterinarian will report to the Site Quality Head/ ... Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro...facilitating communication between the Animal Services team and the Quality organization. This position will work in close coordination… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …record keeping and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the ... Operations team based in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide strategic… more
- Merck & Co. (Rahway, NJ)
- …CMC and Regulatory in aspects of control strategy and filings, Quality and our partners in the commercialization and manufacturing is essential.The successful ... and retaining diverse talent.Extensive knowledge of and hands-on work in applying regulatory guidance and quality standards related to product release and… more
- Eisai, Inc (Nutley, NJ)
- …to hear from you. Job Summary: As the Americas IT Security and Compliance Director , you play a pivotal role in ensuring the organization's adherence to security, ... regulatory , and compliance standards. Collaborating with business and EIT...security and data privacy standards. Your responsibilities span security operations , risk assessment, investigations, and compliance issue resolution for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management Group Head has ... therapeutic areas. The role reports into the Global Clinical Operations VP and is accountable for ensuring the clinical...clinical trial portfolio and submissions are delivered to time, quality , and cost. The teams reporting into this role… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …protocol timelines; considers relevant input and guidance to other areas within NACD including Operations Director and TA Heads End to End Supply Operations ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...a collaborative work culture, including direct partnership with the Operations Director (s) Stakeholder management: Build strong internal… more
