- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for cross functional assistance for PGC, Learning Management System (LMS) and Regulatory , as needed. ResponsibilitiesEditorial Review of Materials Review ... the overall quality of materials subject to Product Material Review Process (PMRP) - including but not limited to:...cross-functional support to Legal Operations as needed Partner with Regulatory Analyst on the submission of all PMRP approved… more
- Merck & Co. (North Wales, PA)
- …Responsibility Essential function(s) includes, but is not limited to: Reporting to Senior Management of the Medical Device and Combination Product (MDCP) Quality ... Assurance Operations team, the Associate Director Quality Engineering & Quality Assurance is responsible for independent compliance support of Medical Devices… more
- Merck & Co. (Rahway, NJ)
- …required, lead execution and support of ancillary agreement creation, such as regulatory agreements.- Review project details, update and track business ... Job DescriptionUnder minimal guidance of the Senior Director or Director, Business Development Execution, the primary function includes coordinating various GRACS… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …assets are easily accessible and properly utilized. Relationships Reports to the Associate Director of Content Management; Provides direct support to the Digital ... multiple NNI internal functions such as Brand Managers, Omnichannel teams, IT, Regulatory and Commercial Insights & Analytic, as well as external operational vendors… more
- Merck & Co. (Rahway, NJ)
- …teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing ... as well as preparing for, management and follow up of regulatory inspections. Primary Duties: Operational Quality Management: Overseeing the strategic implementation… more
- Merck & Co. (Millsboro, DE)
- …Delaware seeks to add an Attending Veterinarian in the role of Associate Director.This position will have overall responsibility for oversight and administration of ... documentation, and other information as needed for annual reports to Federal regulatory agencies. Leadership for internal and external regulatory inspections… more
- Merck & Co. (Rahway, NJ)
- …processes/ methods in conformance to all applicable regulatory requirements, regulatory filings and company policies.The Associate Director also ensures that ... Job DescriptionThe Associate Director, ESQL is responsible for all activities...EQA and Division in specific Quality systems, technology platforms, regulatory expectations and/or EE management, and can represent the… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Senior Technician, MaintenanceThe Senior Maintenance Technician is responsible for providing equipment troubleshooting and ... Quality, Automation, Technology, and other groups as required.The Lab Senior Maintenance Technician will provide maintenance supporting vaccine process equipment… more
- Novo Nordisk Inc. (Boulder, CO)
- …analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder, ... are driving change. Are you ready to make a difference? The Position The Senior Manager of Specialty Raw Materials Manufacturing is responsible for ensuring a steady… more
- Eisai, Inc (NJ)
- …this is your profile, we want to hear from you. Job Summary The Associate Director, Clinical Outsourcing, will oversee and lead and support activities related to the ... and managing service provider business relationships in alignment with global strategies. Review and approve Clinical Quality Assurance audit plans and reports.… 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
- Merck & Co. (Boston, MA)
- Job DescriptionThe Associate Vice President (AVP)/Therapeutic Area Head, Immunology Translational Medicine, will be responsible for leading the Translational ... TMed at governance for the Immunology portfolio (discovery therapeutic area review , early and late-stage clinical governance), and fully supportive of external-based… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Vice President (AVP) will be responsible for leading the Translational Medicine (TMed) Cardiovascular & Respiratory Therapeutic Area and ... governance for the Cardiovascular & Respiratory portfolio (discovery therapeutic area review , early and late-stage clinical governance), and fully supportive of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before database lock and quality check of data; Works… more
- Eisai, Inc (Nutley, NJ)
- …and Analytics plus 2 years of work experience in job offered or as Senior Systems Analyst/Data Analyst/ Associate Projects. Also requires 2 years of experience ... Nutley, NJ.Support clinical applications for clinical data management. Perform data review and data cleaning in Oncology clinical area. Develop dashboard, standard… more
- Publicis Groupe (Philadelphia, PA)
- …| Facebook: www.facebook.com/digitashealth | Twitter: www.twitter.com/digitas_health **Job Description** The Senior Associate , Regulatory Review ... established by our pharmaceutical clients when submitting marketing materials for regulatory review . This includes preparing completed editorial content to… more
- Publicis Groupe (New York, NY)
- …| Facebook: www.facebook.com/digitashealth | Twitter: www.twitter.com/digitas_health **Job Description** The Senior Associate , Regulatory Review ... by our pharmaceutical company clients when submitting marketing materials for regulatory review . This includes preparing completed editorial content to… more
- Publicis Groupe (Philadelphia, PA)
- …| Facebook: www.facebook.com/digitashealth | Twitter: www.twitter.com/digitas_health **Job Description** The Senior Associate , Regulatory Review ... established by our pharmaceutical clients when submitting marketing materials for regulatory review . This includes preparing completed editorial content to… more
- Publicis Groupe (New York, NY)
- …| Facebook: www.facebook.com/digitashealth | Twitter: www.twitter.com/digitas_health **Job Description** The Senior Associate , Regulatory Review ... established by our pharmaceutical clients when submitting marketing materials for regulatory review . You'll report to the Manager, Regulatory Review… more
- Publicis Groupe (New York, NY)
- …effort required to create various components of each submission for a Manager, Regulatory Review or Senior Associate , Regulatory Review + Ensure ... | Facebook: www.facebook.com/digitashealth | Twitter: www.twitter.com/digitas_health **Job Description** The Associate , Regulatory Review works closely with… more
