- Aequor (Newbury Park, CA)
- …requires resourcefulness and critical thinking skills.) Job Title: Sr. Associate - Records Information Management & Systems (RIMS)Job DescriptionKey responsibilities ... Support the implementation of Veeva Vault, IDMP, EU CTR, and other regulatory initiatives. Work with stakeholders to gather requirements and develop solutions.… more
- Merck & Co. (Rahway, NJ)
- …appropriately in a timely manner.Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study ... issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.Identifies, assesses… more
- American Honda Motor Co Inc (Marysville, OH)
- …assist and support the North American Regional Operating Board (NAROB) and senior executives across North America to strengthen risk management, internal controls, ... AHM Audit also promotes self reliance within NA operations and ensures regulatory compliance while maintaining competitive costs but with the highest quality and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …cross functional assistance for PGC, Learning Management System (LMS) and Regulatory , as needed. ResponsibilitiesEditorial Review of Materials Review and consult ... projectsProvide cross-functional support to Legal Operations as needed Partner with Regulatory Analyst on the submission of all PMRP approved promotional material… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Associate Director, RACMC Portfolio Products, will be responsible for regulatory ... for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data, authoring CMC… more
- Aequor (Thousand Oaks, CA)
- …Facing SKU Change Records (CFSCR) Provide timely updates to stakeholders, eg, Regulatory , Supply Chain, Manufacturing, Quality on status of GDCR and/or CFSCR ... readiness activities and related projects Represent the SCPM Hub in Project Planning meetings, Variation Execution Meetings and/or Regional Operations Team meetings Establish effective relationships with key stakeholders across multiple functional areas… more
- Catalent (Harman, WV)
- Senior Director, Supply Chain Position Summary: The Senior Director, Supply Chain is responsible for leading the supply chain organization for Catalent Maryland. ... suites coming online.Reporting to the Vice President and General Manager, the Senior Director Supply Chain directs all facets of supply chain management including,… more
- Merck & Co. (North Wales, PA)
- …of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.- Specifically, the Senior Director ... talented and dedicated colleagues while developing and expanding your career.The Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provides a seamless user experience for customers. 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)
- …products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead cross-functional ... integration of the device development activities with the clinical, regulatory , formulation, commercial and other key company functions.Represent Device Development… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Senior Specialist, Manufacturing Automation The Senior Specialist Manufacturing Automation person is primarily responsible ... interaction with manufacturing, quality, IT, and engineering groups. - The Senior Specialist for Manufacturing Automation is responsible for providing automation… more
- Eisai, Inc (Nutley, NJ)
- …to the Senior Director, Omnichannel Marketing (HCP and Patient). The associate director will also partner closely with key internal partners to deliver ... omnichannel and media specific marketing input and activities.The Associate Director of Omnichannel Marketing and Media is responsible for managing, executing and… more
- Eisai, Inc (Nutley, NJ)
- …, manufacturing, legal, market access etc.)Requirements:Rising junior or senior undergraduateWorking knowledge of accounting and financeScience background preferred ... this is your profile, we want to hear from you.Job Summary:The Summer Associate will support Eisai's US Business Development & Established Products Group. This role… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …equal opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing Clinical ... hands on population PK and PKPD analyses and participate in regulatory interactions and submissions representing the Clinical Pharmacology and Pharmacometrics/… 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
- 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
- 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 ... outsourcing.In-depth understanding of GCP/GLP guidelines, audit processes and agency regulatory requirements.Excellent verbal, written and interpersonal skills and ability… 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 Technical ... Operations team based in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide strategic direction… more
- Merck & Co. (Rahway, NJ)
- …and developments align with business requirements, industry standards, and regulatory compliance.Adhere to change control processes and methodologies to minimize ... technical experience; competence in clear concise and tactful communication with senior management, clients, peers and team members. Travel Requirements: 10-15%… more
- Merck & Co. (Rahway, NJ)
- …on a variety of Quality or compliance-related issues.Interprets complex regulatory requirements for various audiences, including source area management, and ... requirements across stakeholders.- Reviews draft policy and standards.Communicates with senior management within our Company and the contractor organization.-… more
