- Daiichi Sankyo, Inc. (Bernards, NJ)
- …systems across the organization. This position ensures that all global systems , electronic records, validation processes , and regulated applications meet ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Novo Nordisk Inc. (Boulder, CO)
- …worlds to develop new medicines for patients. The Position The Technical Team Lead , API Manufacturing works in Novo Nordisk's Boulder, Colorado Pilot Plants and is ... supply of API and meeting production goals, the Technical Team Lead actively supports continuous improvement initiatives and identifies wherever possible… more
- BioAgilytix (Durham, NC)
- …go-to person for everything related to data. You'll build the rules, processes , and cloud pipelines that keep lab and business information accurate, secure, ... access control, and compliance protocols.Define standards, build quality assurance processes , and monitor data integrity to meet regulatory requirements, including… more
- Genmab (NJ)
- …Then we would love to have you join us!The Role & DepartmentThe Feasibility Lead supports the vision and strategy set forth by the Head of Strategic Feasibility. ... of development.Partners with key stakeholders within Global Development Operations (GDO), Medical Affairs, Medical , and/or CROs, to enable expedited, predictive… more
- Eisai, Inc (Dallas, TX)
- …Investigators involved in company sponsored post-marketing studies. Professional Organization Support Lead field medical efforts in support of Eisai's ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides...congresses in accordance with MSL plan. Be prepared to lead congress coverage efforts, including coordination of all MSL/Sr.… more
- Aequor (Thousand Oaks, CA)
- …label tool Monitor the compliance of autolabel tool updates (if applicable) Support and lead Quality Assurance of ICSR medical review (if applicable) Support and ... Produce medically accurate ICSRs reports Act as MSRT product lead and/or therapeutic area lead Execute ICSR...patient populations and drug class Proficiency in technical safety systems including the Safety database and medical … more
- Merck & Co. (Durham, NC)
- …and versatile leader for External Manufacturing Operations, Drug Delivery Systems and Devices within our Manufacturing Division (Associate Director).-This role ... and test complex injection molded Device Components, Device Constituents, and Medical Devices used to deliver Pharmaceutical, Biologic, and Vaccine Products. Our… more
- Eisai, Inc (Exton, PA)
- …Framework: Responsible as assigned, to design and deploy Quality Assurance (QA) processes , procedures, and systems (including QMS) to assure compliance with ... systems .Creates and updates corrective and preventative action (CAPA) processes , procedures and systems for GxP ...GxP environments.2+ years in a leadership role in GxP Systems Quality Assurance. Must be able to lead… more
- Aequor (Devers, TX)
- …migration from Oracle to SAP, focusing on transactional procurement data and processes . The ideal candidate will have extensive knowledge of SAP, sourcing, and ... to the Devens Associate Director, Cell Therapy Site Procurement Lead and can be based at one of the...and SAP Subject Matter Expert and drive best-in-class business processes and acumen for successful ERP implementation.Consulting and Escalation… more
- Merck & Co. (Durham, NC)
- …Site in Durham, NC is hiring Operations Managers across multiple products and processes . The hiring team will determine based on your experience and skill set ... to operations personnel who are accountable for the manufacturing processes . They will also actively manage their assigned team...opportunity to become proficient in the use of manufacturing systems and build knowledge of site procedures in order… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... of laboratory data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs and other vendors to ensure… more
- Eisai, Inc (Exton, PA)
- At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care ... biological Drug Substance (DS) / Antibody Drug Intermediate (ADI) production processes for new products in development through their lifecycle (Preclinical through… more
- Novo Nordisk Inc. (Durham, NC)
- … processes . Relationships Reports to Manager, QA. Essential Functions Ensure plant systems batch release & relevant quality processes are compliant with ... 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases,...& approval of validation activities associated with projects, new systems , changes to existing systems & maintaining… more
- Novo Nordisk Inc. (Durham, NC)
- …Collaborate, execute, & review IQs, OQs, PQs, & other verification protocols for systems / processes Author & review documents in accordance with local, corporate ... 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases,...which address & eliminate potential reoccurrence of the failures Lead the development of new processes &… more
- Eisai, Inc (NJ)
- …field of study with 8 years of relevant experience.Experience with Veeva Vault eTMF processes and systems is a must, including proficiency in writing test ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides...related inspection readiness activities.Must have good understanding of computer systems validation and related processes . Knowledge and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... is responsible for the analysis and design of business processes in this business area and is also responsible...modules integrate seamlessly with other SAP modules and third-party systems , by working closely with internal and external support… more
- Merck & Co. (Knoxville, TN)
- …Strategy, Health Improvement, Health Outcomes, Hospital Sales, Interpersonal Relationships, Lead Generation, Managed Care, Market Analysis, Medical Affairs, ... to execute their role including:-clinics, health departments, integrated delivery systems , and hospitals . The VCR is a...such as the Vaccine Key Customer Leader (VKCL), Vaccine Medical Affairs Leader (VMAL), Region Medical Director… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... and support materials for end-users, handling of queries, troubleshooting, and quality control. Lead or support consulting and implementation projects in the area of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …projects.Participate and lead in the development of corporate-wide systems , procedures, and tools that facilitate efficient processes throughout ... of facility and equipment for new projects and existing qualified systems within cell therapy manufacturing. The Commissioning and Qualification Project Manager… more
- Merck & Co. (Austin, TX)
- …clinical training programs and resources. We support healthcare providers and healthcare systems in meeting the healthcare goals of the patients in their ... model. The PVAR is responsible for engaging with assigned customers (ie, pharmacy, medical groups, physician offices) in a way that supports the local market focus… more
