- Tris Pharma (Monmouth Junction, NJ)
- …strategic leadership and direction for Clinical Quality Assurance Operations, ensuring compliance with regulatory standards and driving implementation and ... New Jersey, Tris has an immediate opening for a full-time permanent Director/ Senior Director, Clinical Quality Assurance. This is a hybrid position. Job Title… more
- Merck & Co. (Rahway, NJ)
- …for our Company divisional and local site procedures for safety, quality, and regulatory compliance .Understand the big picture, and how activities link to our ... Job DescriptionWe are seeking a Growth and Improvement minded Senior Engineer in Device Technology that can help drive our Strategic Operating Priorities.Invent -… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to regulatory process optimizations on relevant topics.Responsibilities- Supports CMC regulatory compliance activities for portfolio biologics to meet US, ... The Associate Director, RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …new vendors and oversee infrastructure projects to ensure robust and secure IT environments. Regulatory Compliance : Ensure IT systems comply with 21 CFR Part 11, ... Exela Pharma Sciences is seeking an experienced and dynamic Senior Manager, IS Quality to build and lead our...audit programs and lead IS quality audits to ensure regulatory compliance and successful outcomes. Participate in… more
- Eisai, Inc (Boston, MA)
- …of: NYC, NJ, RI, CT, MA, NH, ME, VT Job Summary The Senior Manager, Access and Reimbursement will appropriately inform, support and manage regional customers' ... patient assistance, reimbursement support, distribution and coverage policies). The Senior Manager, Access and Reimbursement is a customer-facing resource that… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Exela Pharma Sciences is searching for a talented Senior Buyer to join our Supply Chain team. Experience within the pharmaceutical industry is not essential, ... a desire to create value for Exela and facilitate continuous process improvements.As a Senior Buyer, you will play a vital role in the procurement process by… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Senior Scientist, Microbiology (Lab Lead) - Analytical Research & Development (Onsite) Small Molecule Analytical Research and ... Development (SMARD) is seeking a highly motivated Senior Scientist -Microbiologist to join the growing Microbiology Center of Excellence (COE).- This position is… more
- Merck & Co. (Rahway, NJ)
- …biologics, vaccines, antibody drug conjugates (ADCs), in addition to others.- --The Senior Specialist, Engineering will serve as a business representative in the ... Familiarity with United States and European Union cGMP and Safety compliance regulations.Ability to prepare Risk Assessments, Standard Operating Procedures (SOP) and… 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 ... the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The incumbent is responsible for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …focus even under adversity Operational mindset and continuous improvement: Considers compliance , regulatory , quality assurance and other requirements when ... Category Leaders and Managers Scopes out high-profile supplier engagements for senior level executives, develops and negotiates agreements and manages suppliers to… more
- Merck & Co. (Philadelphia, PA)
- …fieldRequired Experience & Skills:5 years of experience in Procurement, Compliance , Quality, Technology, Manufacturing/Operations, Supply Chain or related Business ... and / or improve Third Party/Supplier relationshipsKnowledge of Finance, Regulatory /Quality, Privacy and Legal expectations for Global ProcurementRole is expected… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …brand marketing, market access, commercial effectiveness, sales, medical/CMR, legal, compliance , and regulatory . Other internal relationships include Public ... teams, Brand Marketing, Training, Commercial Insights and Analytics, Managed Markets, Legal, Compliance , and Finance. The position has high exposure to senior … more
- Merck & Co. (Lenexa, KS)
- …and adverse reports in accordance with internal, FDA, CFIA and USDA regulatory policies.The successful candidate for this position will be required to maintain ... aimed at answering customer and industry questions, monitoring protocol compliance , and summarizing results from post-approval marketing support trials specific… more
- Eisai, Inc (Nutley, NJ)
- …communications and strategies across the brand's target audiences and to ensure regulatory /legal requirements are met. The SPM will lead efforts on developing ... on brand initiatives and programs.Participate in Medical, Legal, and Regulatory approval process for promotional programs. 20% Monitor products, marketplace,… more
- Eisai, Inc (Indianapolis, IN)
- …to work independently and not require close supervision while adhering to compliance / regulatory policies. Interest in leading and participating in projects while ... effectively balancing field work. Demonstrated ability to proactively identify opportunities/challenges, willingness to communicate these challenges to leadership while working together to overcome them. Seamlessly adapts to field situations and effectively… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …addressed and managed appropriately. Ability to exercise influence at the senior leadership and/ or executive level wherever GLP/non-GLP/ research programs impacting ... Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents… more
- Merck & Co. (Durham, NC)
- …the above-listed Quality Systems to ensure compliance with all global and regulatory standards. Develops and report to senior leadership data analysis and ... to align staff activities with department objectives. Understands and applies regulatory / compliance requirements. FUNCTIONAL EXPERTISE: Specific to the following… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for support and manage Quality Management System (QMS) in accordance with regulatory requirements and to ensure the adherence to the Quality Manual. Responsible ... adherence to the implementation of global and harmonized Quality Standards and regulatory requirements for GMP area. Responsible for the creation and review Quality… more
- Merck & Co. (Rahway, NJ)
- …pharmacokinetics modeling software (eg, Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product ... biopharmaceutics technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of post-law school experience required- 4 or More Years experience in regulatory , compliance , and legal matters relating to investigational products, product ... but not limited to, areas of vendor agreements, legal, business and regulatory issues. Coordination with, and appropriate supervision of, outside counsel as is… more
