- Windstream (Columbus, OH)
- …our customers Internet better (TM) every day. About the Role: As a Material Manager on the Kinetic engineering and OSP construction team you are responsible for the ... Commission, is required to notify and to obtain approval from federal regulatory agencies prior to granting certain system/network access to any non-U.S. citizen… more
- Aequor (Thousand Oaks, CA)
- … regulatory history documents through IMR and appropriately archive all regulatory documents and agency communications. o Ensure compliance with submissions ... mixed background not just lab but manufacturing and process development. This manager position within CMC will facilitate product development and global registration… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …amount of system validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service ... various contractors meets Global DX Computer System Validation requirements, global regulatory compliance , and global Quality expectations. Partner with global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …considered for all Medical Affairs programs. Interact with legal and compliance as required. Proactively collaborate with other GxP quality representatives and ... adequate systems and process support, including facilitation of respective regulatory inspection preparation, management and follow-up in collaboration with impacted… more
- Amerant Bank (Coral Gables, FL)
- …to thrive in a fast-paced startup environmentProfessional certifications such as Certified Regulatory Compliance Manager (CRCM) a plusAbility to manage ... or more years of experience in an equivalent role with residential compliance experience, in regulatory compliance at a bank, mortgage lending company or… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …GMP Compliance Programs to assure product quality, integrity and compliance with regulatory guidelines and internal/global standards and procedures. ... the timely release and delivery of pharmaceutical products as per applicable regulatory standards and company expectations for products. The incumbent is responsible… more
- Lundbeck (Sacramento, CA)
- …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 ... addition to other payer channels including Medicaid and Commercial. Pharmaceutical Environment/ Compliance - Ability to apply knowledge of pharmaceutical and … 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, ... Pharma Sciences is seeking an experienced and dynamic Senior Manager , IS Quality to build and lead our IS...audit programs and lead IS quality audits to ensure regulatory compliance and successful outcomes. Participate in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the ... area including functional representatives, corporate representative, IT, privacy, legal, compliance , IT security, etc.Responsibilities- In conjunction with the Director… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: Manager , Sales Training and Development - Oncology serves as the training subject ... and ensure all projects and materials have been through the correct regulatory review process before being delivered to field sales forces.Support secondary customer… 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' needs ... patient assistance, reimbursement support, distribution and coverage policies). The Senior Manager , Access and Reimbursement is a customer-facing resource that is… more
- Eisai, Inc (Nutley, NJ)
- …activities relating to clinical study Trial Master Files (TMF), ensuring regulatory inspection-readiness and compliance with applicable laws and regulations. ... profile, we want to hear from you. The Sr. Manager is to lead collaboration efforts with R&D IT...and transformation initiative and is compliant with ICH-GCP and regulatory requirements . Th is role also provides direction,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …problem-solving and decision-making skills using data analysis.Familiarity with regulatory requirements, safety standards, and compliance .Visionary mindset ... Position Summary The General Manager and VP of Manufacturing will be a member of the Exela leadership team. In this position, you will have overall responsibility… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …the Director of Research Administration and under limited direction, the Contracts Manager - Federal Contracts and Compliance , will oversee end-to-end contract ... of the Office of Research Contracts (ORC).The Contracts Manager - Federal Contracts and Compliance will...DCA audits and prepare and file all necessary governmental regulatory reports and plans.The Manager will also… more
- Insmed Incorporated (San Diego, CA)
- …join the Quality Control leadership team. As the QC Stability and Sample Management Manager , you will be responsible for the daily oversight for the QC stability and ... support associated investigations, including: temperature excursion assessments, client and regulatory requests, and investigational testing. Assist in creating a… more
- Lundbeck (Stockton, CA)
- …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 ... issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources. Pharmaceutical Environment/ Compliance - Ability to apply knowledge of pharmaceutical and … more
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. The Sr. Product Manager (SPM), US Oncology Women's Cancer, is responsible for contributing to the strategic ... communications and strategies across the brand's target audiences and to ensure regulatory /legal requirements are met. The SPM will lead efforts on developing… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to make a difference? The Position We are looking to hire a Clinical Project Manager (CPM). This is a unique opportunity to work in a growing Clinical Operations ... of CROs, third party vendors, and contractors, including co-monitoring, to ensure compliance with study protocol, and identifying areas of concern and escalating to… more
