- Merck & Co. (Rahway, NJ)
- …the companyEducation:Bachelor's degree with 12+ years of industry experience, including regulatory and/or compliance area and experience with process management ... efficient, effective, and compliant business standards, process maps, and risk management for global processes across GRACS. The GPL...minimum of 8 years of industry experience including a regulatory and/or compliance area and experience with… more
- Merck & Co. (Rahway, NJ)
- …to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on ... and solutions to the world.Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:Developing regulatory … more
- Merck & Co. (Rahway, NJ)
- …to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on ... the world.Looking for someone with a growth mindset.Position Description: The Senior Director , Global Regulatory Lead, is responsible for development and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …specifically GLP/GCLP studies.Partners with Audit and Compliance QA function to develop compliance and risk criteria, in order to assure compliance with ... Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents… more
- Merck & Co. (Rahway, NJ)
- …Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory / Risk Management, Quality Assurance, Medical Affairs, Translational ... efficient, adaptable, and scalable architectures in accordance with company policies, regulatory standards, and integration methodology. Work with the business users… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder minimal guidance of the Executive Director / Director /Associate Director , Pharmacovigilance (PV) Partner Strategy & Management (PV-PSM), ... of PV agreements, PV plans, and SMPs.Maintains, in collaboration with the Executive Director / Director / Associate Director PV-PSM, the internal guidelines and… more
- Merck & Co. (Millsboro, DE)
- …and unregulated species including chickens, turkeys, dogs, cats, rabbits, and rodents.Assure compliance with all federal and state regulatory requirements for ... Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro...company's Millsboro Animal Health facilities. This role is highly compliance -driven in accordance with State and Federal regulations as… more
- Merck & Co. (NJ)
- …Process to manage assurance of supply, quality, service, cost, innovation and regulatory compliance within Global or International category of spend, resulting ... are grouped into center-led categories and regional operating teams.The Associate Director of Global Operations Sourcing has direct responsibility for a portfolio… more
- Merck & Co. (North Wales, PA)
- …Sponsors.Delivery of work consistent with Quality standards (meets legal & regulatory requirements & maintains compliance technology standards where ... development, installation, prioritization, and realization of key capabilities.The Associate Director , Content Standardization - Modular Content will be responsible… more
- Merck & Co. (Rahway, NJ)
- …Experience and Skills: Knowledge of Investigational drug regulatory requirementsAudit experience: safety, environmental, compliance /qualityUnderstanding ... FLEx Center in Rahway is looking for an Associate Director - Process Engineer to lead clinical supply manufacturing,...of growth.Familiarity with US and EU GMP and Safety compliance regulations.Desire and willingness to learn, contribute and lead… more
- Merck & Co. (Rahway, NJ)
- …The successful candidate will be accountable for proactive resourcing planning, risk assessment strategies and will focus on talent development and partnering ... cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for… more
- Merck & Co. (Rahway, NJ)
- …to bring analytical representation and expertise to project teams and support regulatory filings (eg, INDs/IMPDs and BLAs).-The Director selects, trains, and ... Job DescriptionThe Director of Biologics Potency in Analytical Research &...The successful candidate will be responsible for resourcing planning, risk assessment strategies, talent development, and partnering to build… more
- Merck & Co. (Rahway, NJ)
- …of regulated documentation in support of the clinical development portfolio and compliance in public disclosure of clinical trials and their results, document ... disclosure, and data sharing with external researchers. The Executive Director in Medical Writing will be responsible for overseeing clinical trial data… more
- Merck & Co. (Durham, NC)
- Job DescriptionAs the Vaccine Automation Director , you will be the primary point of contact for the HPV IPT for all digital implementations, support, and ... the liaison between above site DMO and the site clients.- The Vaccine Automation Director works with the HPV IPT, Supply Chain, and Technical Operations site leads… more
- Insmed Incorporated (San Diego, CA)
- …for Millennials™, and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Program Management, the Associate Director , Program Management ... accordance with the program strategy. In addition, the Associate Director of PM may be asked to lead and/or...teams and ad hoc project team meetings Conducts the risk management and scenario planning and develops contingency and/or… more
- Merck & Co. (Rahway, NJ)
- …and implement robust SAP security policies, procedures, and controls.Ensure compliance with regulatory requirements and industry best practices.Manage ... and overall role administration. This role reports to Executive Director , SAP Platform Team. Primary Responsibilities: Leadership and StrategyProvide strategic… more
- Insmed Incorporated (San Diego, CA)
- …represent Insmed Gene Therapy as subject matter expert during external and internal regulatory submissions and compliance inspections. Travel will be required to ... and Best Medium Workplaces™ lists.OverviewJoin the Technical Operations team as Associate Director of MSAT where you will support pipeline programs that change… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …protocols and reportsServe as reviewer/author of a variety CMC sections or regulatory submissions, risk assessments, validation impact assessments, global change ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director , Global Process Validation as part of the Technical Operations team based… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …internally and with external parties. Ensure that all employees are in compliance with all contract requirementsSupport the Associate Director Global Strategy ... Global RD and PV QA organizational strategy in collaboration with the Associate Director Global Strategy and Operations and Head Global Strategy and Operations. In… more
