- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position SummaryThe Technical Data Reviewer reports to the Data Review Supervisor or quality management (ie, Manager or Director). The reviewer will be ... with Raw Material, Finished Drug Products, Stability and Microbiology testing. Data Review may include release, raw material, and stability data and laboratory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …standards for continuous improvement and operations excellence. This may include the review of business partner SOPs and participation in QA initiatives.Partner and ... continuous process improvement activities within QA, as necessary.Participate as a Quality Reviewer for Health Authority inspections in the US, in collaboration with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for global labeling projects. Under the direction of the labeling leadership, the manager will develop, review and revise labeling for FDA submission, create ... as other research areas centered around rare diseases and immune disorders. SummaryThe Manager , Regulatory Affairs Labeling position will provide Regulatory support… more
- Merck & Co. (Durham, NC)
- …and patients on time, every time, across the globe. GENERAL SUMMARY: The Manager , Teknika QC laboratory, is responsible for managing a team of individual ... such as change control, deviation management, audits and regulatory inspections.- The Manager will be responsible for using principles of our Company Production… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary: The Manager of CRA Monitoring Oversight and Excellence is responsible for the support ... study/CRO plans across the portfolio.Ensure study-specific monitoring plans meet the above standards. Review quality oversight plans that CRO CRAs have in place to… more
- Merck & Co. (Millsboro, DE)
- …overseeing the preparation, usage and storage of sterile tanks. The area manager ensures all schedules are met while following all safety and standard ... of additional labor, such as temporary employees or other departments Review and revise processes and procedures against corporate and regulatory requirements… more
- 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)
- …supply of API, during the execution of the job duties, the senior manager should seek to actively support continuous improvement initiatives and identify wherever ... activity Work with internal and external resources to develop and review manufacturing documentation, SOPs, protocols, risk assessments and reports Support equipment… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …Senior Director of Financial Operations, the General Accounting and Accounts Receivable Manager will coordinate and oversee all of the Institute's daily General ... receivable functions to ensure accurate and efficient financial operations.The Manager will have primary responsibility for ensuring all accounting functions… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …customer account approaches Follows-up with internal and external stakeholders to review product value, quality of care and account satisfaction Physical ... Requirements 50-75% overnight travel required. Qualifications A bachelor's degree required Master's degree in business-relevant field preferred At least 7 years pharmaceutical/biotech/healthcare industry experience required A Minimum of 2 years successful… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment of multiple myeloma.Legend Biotech is seeking QA Batch Disposition Associate Manager as part of the Quality team based in Raritan, NJ. Role ... Responsibilities Manage the team responsible for drug product batch record review and drug product release practices.Develop positive relationships with the QA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Manager , Medical Coding is accountable for delivery of medical coding services for ... dictionary documentation. Produces coding reports for periodic predefined study team review . Compiles feedback provided and issues queries and actions site query… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Manager , Data Programmer is a member of the Biostatistics and Data Management ... as per CDISC SDTMIG. Perform SAS programming to provide complex data review listings and reports to support Data Management and clinical teams. Develop,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Quality Compliance Manager as part of the Quality team based in Raritan, NJ. Role ... OverviewThe Quality Compliance Manager is responsible for regulatory compliance supporting the production...team, ad hoc, for activities such as annual product review , site risk register, or internal quality agreements.Develops and… more
- Novo Nordisk Inc. (Charlotte, NC)
- …as a leader in the hemophilia marketplace. The Rare Blood Therapy Manager (RBTM) must assume responsibility for achieving sales objectives by implementing approved ... in good standing by not exceeding the Novo Nordisk points threshold assigned based on review of Motor Vehicle Records. This is a TWO State geography: NC and SC with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you ready to maximize your potential with us? The Position The Associate Manager of Technical Production will be responsible for overseeing the technical aspects of ... office as well as multiple managed services. Interacts with Director daily to review the day-to-day happenings in the home office ensuring that client/ stakeholders… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Global Service Manager (GSM) focusing on Incident, Problem, and Change is responsible for the ... leadership, and external vendors/partners to execute responsibilities.- Responsible for review , approvals, categorizing, prioritizing, of change requests.- Analyze Service… more
- Novo Nordisk Inc. (Little Rock, AR)
- …customer account approaches Follows-up with internal and external stakeholders to review product value, quality of care and account satisfaction Physical ... by not exceeding the Novo Nordisk points threshold assigned based on review of Motor Vehicle Records. Qualifications A Bachelor's degree required Master's degree… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Operations Manager as part of the Technical Operations team based in Raritan, NJ. ... Role OverviewThe CAR-T Operations Manager is an exempt level position working within Technical...production schedules. This individual will also lead facility operating review meetings and own various department projects to drive… more
- Tris Pharma (Monmouth Junction, NJ)
- …/Paralegal to join our small, but experienced, in-house Legal team.The Contracts Manager /Paralegal supports the Legal department in the review , drafting and ... compilation of varied and complex business contracts across the organization. The incumbent reviews contracts to ensure compliance to company policy, government specifications and other legal and company requirements. She/he collaborates closely with cross… more
