- Aequor (Newbury Park, CA)
- …and deliver training materials and presentations to a global audience. Author/ review /approve quality Regulatory Information Management & Systems documents ... requires resourcefulness and critical thinking skills.) Job Title: Sr. Associate - Records Information Management & Systems (RIMS)Job DescriptionKey responsibilities… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, 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
- American Honda Motor Co Inc (Marysville, OH)
- …governance concepts throughout the business and support business planning activities. The Senior Auditor may periodically direct and review the work performed ... assist and support the North American Regional Operating Board (NAROB) and senior executives across North America to strengthen risk management, internal controls,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good Clinical ... process in evaluating study budgetsCollect information and coordinate with DS Regulatory Operations to post trial information on required public forums… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for cross functional assistance for PGC, Learning Management System (LMS) and Regulatory , as needed. ResponsibilitiesEditorial Review of Materials Review ... the overall quality of materials subject to Product Material Review Process (PMRP) - including but not limited to:...cross-functional support to Legal Operations as needed Partner with Regulatory Analyst on the submission of all PMRP approved… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Associate Director, RACMC Portfolio Products, will be responsible for regulatory ... for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data, authoring CMC… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Senior Specialist, Manufacturing Automation The Senior Specialist Manufacturing Automation person is primarily responsible ... interaction with manufacturing, quality, IT, and engineering groups. - The Senior Specialist for Manufacturing Automation is responsible for providing automation… more
- Novo Nordisk Inc. (Boulder, CO)
- …analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder, ... are driving change. Are you ready to make a difference? The Position The Senior Manager of Specialty Raw Materials Manufacturing is responsible for ensuring a steady… more
- Merck & Co. (Boston, MA)
- Job DescriptionThe Associate Vice President (AVP)/Therapeutic Area Head, Immunology Translational Medicine, will be responsible for leading the Translational ... TMed at governance for the Immunology portfolio (discovery therapeutic area review , early and late-stage clinical governance), and fully supportive of external-based… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Vice President (AVP) will be responsible for leading the Translational Medicine (TMed) Cardiovascular & Respiratory Therapeutic Area and ... governance for the Cardiovascular & Respiratory portfolio (discovery therapeutic area review , early and late-stage clinical governance), and fully supportive of… more
- Catalent (Harman, WV)
- Senior Director, Supply Chain Position Summary: The Senior Director, Supply Chain is responsible for leading the supply chain organization for Catalent Maryland. ... suites coming online.Reporting to the Vice President and General Manager, the Senior Director Supply Chain directs all facets of supply chain management including,… more
- Eisai, Inc (NJ)
- …this is your profile, we want to hear from you. Job Summary The Associate Director, Clinical Outsourcing, will oversee and lead and support activities related to the ... and managing service provider business relationships in alignment with global strategies. Review and approve Clinical Quality Assurance audit plans and reports.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. SUMMARYThe Associate Director, Pharmacoepidemiology position provides epidemiologic, methodological, and analytic ... analysis of epidemiologic studies, including real-word evidence (RWE), supporting senior management in various epidemiological activities.This position independently carries… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before database lock and quality check of data; Works… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …plan and tactics is made available to the field-based Medical Liaison Associate Directors/Directors Review and audit direct report expense reports. Manage ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...and field alignment directors. They will also be the senior strategic representative of medical affairs in the relevant… more
- Lennar Title (Orlando, FL)
- …operational processes and procedures to ensure compliance with company policies, regulatory guidelines, and industry standards. Review Documentation: Review ... to exceed superior standards and exceptional services. #CB#LI-AR1 Responsibilities This Senior Internal Auditor (hybrid work environment with 25-50% travel amongst… more
- Fidelity TalentSource LLC (Boston, MA)
- …provides advisory services for select strategic initiatives and modernization efforts. The Senior Associate role will deliver significant value to the business ... processes, and systems. This role will report to a Senior Manager or a Director within the GFC function....is not limited to a criminal, civil litigations and regulatory review , employment, education, and credit … more
- Fidelity TalentSource LLC (Boston, MA)
- …investigation includes but is not limited to a criminal, civil litigations and regulatory review , employment, education, and credit review (role dependent). ... exams completedKnowledge of benefit program design, legislative, account and regulatory requirements (IRS/DOL/FAS/PBGC/ERISA/409A/PPA) The Skills You Bring You have… more
- Fidelity TalentSource LLC (Smithfield, RI)
- …investigation includes but is not limited to a criminal, civil litigations and regulatory review , employment, education, and credit review (role dependent). ... Job Description: Senior Manager, Advanced Data Analytics and InsightsThe RoleFidelity...offsite with maximizing time together in person to meet associate and business needs. Currently, most hybrid roles require… more
- Fidelity TalentSource LLC (Boston, MA)
- …investigation includes but is not limited to a criminal, civil litigations and regulatory review , employment, education, and credit review (role dependent). ... Job Description:As a Senior Manager, Compensation you will be a member...offsite with maximizing time together in person to meet associate and business needs. Currently, most hybrid roles require… more
