- Merck & Co. (Durham, NC)
- …finished product, and laboratory testing for the BCG vaccine.The Quality Operations Laboratory Manager leads a team of analysts in the start-up and method transfer ... to work cross-functionally with existing Laboratories and organizations. The Laboratory Manager will be responsible for start-up testing in new laboratories using… more
- Novo Nordisk Inc. (Boulder, CO)
- …dynamic professional to manage parenteral drug product manufacturing, and corresponding CMC regulatory activities. The Manager of Drug Product Manufacturing is ... analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions. The position will perform validation of the electronically… more
- BioAgilytix (Durham, NC)
- The LIMS Project Manager at BioAgilytix will oversee the comprehensive implementation, customization, and optimization of the LabVantage Laboratory Information ... from planning to post-implementation support, with a strong focus on regulatory compliance and lab efficiency.Key ResponsibilitiesProject Leadership: Lead the onsite… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Centers of Excellence, Corporate Communications, etc.) Also interacts with Sales, Medical, Regulatory , and Legal. The Manager leads, manages, and directs a ... distribution and lifecycle management of promotional marketing materials. The Manager will oversee the process across designated portions of...costs and reduce time to market PRB Budgeting and Reporting : Manage PMM budget as it relates to the… more
- Aequor (Thousand Oaks, CA)
- …experience within Pharma, Biotech, Med DeviceResponsible for coordination, status reporting and stability of Combination Product Operations (CPO) project activities. ... on time. The qualified candidate will support verification, validation, and regulatory submissions of these devices. Work within a cross-functional organization to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …roadmap, leading innovation, communication strategies, identifying and managing KPI's, reporting strategies, and the implementation of system enhancements in areas ... systems to ensure they meet the needs of the business and regulatory requirements.- Collaborate with business units to identify opportunities for enhancing HCP… more
- Lundbeck (Indianapolis, IN)
- …transform lives. Join us on our journey of growth!As a Psychiatry Account Manager , you lead the promotion of our psychiatry portfolio, executing sales and marketing ... Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and… more
- Lundbeck (Knoxville, TN)
- …and transform lives. Join us on our journey of growth!As a Neuroscience Account Manager , this is an incredible opportunity to join the growing promotion of our CNS ... Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and… more
- Lundbeck (Boston, MA)
- …lead the way in creating positive customer experiences!As a BioPharmaceuticals Account Manager , you lead the promotion of our infusion product, driving demand ... Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including Lundbeck policies and procedures and FDA regulations… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …This includes the strategic assessment, deal structure, analysis, forecasting and reporting of contract profitability of customer segments (eg, Managed Care, ... on deal and contract activity Responsible for staying current on pricing, regulatory guidelines, market trends, and competitive activity, and provides information to… more
- Eurofins USA Food Testing (North Platte, NE)
- …in Europe over the past 20 years. Position Summary: The Laboratory Operations Manager receives sufficient authority from, and is accountable to, the Business Unit ... Manager or appointed designate for the successful completion of...equipment operating instructions, manuals, and required logbooks. Ensures all regulatory procedures pertaining to sample testing are followed correctly,… more
- Eisai, Inc (Nutley, NJ)
- …and concisely in both verbal and written format.Excellent documentation and reporting skills to meet legislative, regulatory , and corporate ... responsibilities from both the strategic and execution perspectives for Eisai. Reporting directly to the Executive Director, IT Security, Compliance, & Architecture,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the Fellowship Director throughout the two-year program and will also have a reporting relationship with a manager /preceptor in the respective functional areas ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...of the role and responsibilities of a Medical Information Manager in a pharmaceutical industry setting. Provide verbal, written,… more
- Novo Nordisk Inc. (Los Angeles, CA)
- 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
- Tris Pharma (Monmouth Junction, NJ)
- …the successful marketing and managing of the company's portfolio of products. Reporting to, and collaborating closely with, the Chief Commercial Officer (CCO), the ... and programs are in full compliance with Medical, Legal, Regulatory and Corporate guidelines; Establishes, oversees implementation, and monitors adherence… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- The SQE Manager , QA Compliance, is responsible for managing the Supplier Quality Program at Exela ensuring timely completion of associated activities and ensuring ... compliance with all CFR, USP, cGMPs, and SOPs. SQE Manager , QA Compliance will rely on experience and judgment...in compliance with local procedures, corporate policies, and the regulatory requirements of the US Food and Drug Administration.Job… more
- Aequor (West Greenwich, RI)
- …role? Role supports quality management systems, office based, EW will be supporting recall regulatory reporting 50% of their time and other projects for the QMS ... Feedback from Hiring Manager intake call: What location will this role...are the exact shift hours/schedule the contractor will be working/ reporting ? Mon-Friday standard business hours 8-5 PM What is… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Releases product based on Quality Assurance record review and approval by Manager , Quality Assurance Review and assess Corrective and Preventive Actions Reviews and ... documentation Reviews and assesses deviations; includes tracking, follow-up and reporting /trending Reviews manufacturing and support records to certify compliance… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Releases product based on Quality Assurance record review and approval by QA Manager Performs regular internal audits of NNUSBPI facilities as a lead auditor Works ... Reviews and assesses Deviations, including evaluation, tracking, follow-up, and reporting / trending. Possess signature authority for deviation closure Reviews… more
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