- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...development or approval for either the US or EU.Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to… more
- Merck & Co. (Millsboro, DE)
- …Millsboro Delaware seeks to add an Attending Veterinarian in the role of Associate Director .This position will have overall responsibility for oversight and ... DEA, DNREC, etc.) of animal facilities and program reviews is required.PurposeThe Associate Director /Attending Veterinarian will report to the Site Quality Head/… more
- Merck & Co. (Durham, NC)
- Job Description- The Associate Director of Quality Systems provides leadership, focus, and governance to the Hilleman site in the following Quality Systems: ... Annual Product Review Authoring, Quality Risk Management, and Quality Council), the Associate Director will be responsible for comprehensive management of all… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for ... to regulatory process optimizations on relevant topics.Responsibilities- Supports CMC regulatory compliance activities for portfolio biologics to meet US,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary: The Associate Director , Regional Marketing Conventions & Field Programs will be ... and more, while ensuring adherence to DS policies and procedures. The Associate Director , Regional Marketing Conventions & Field Programs is responsible… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of ... Medical teams as well as alliance partners, promoting a cohesive team approach. Regulatory and Safety Compliance : Understand study conduct from supply chain/drug… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and ... Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research,...architecture. Advocates for good architecture and design practices and compliance in all relevant areas. Assists IT and business… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in collaboration… more
- Merck & Co. (North Wales, PA)
- …We are currently recruiting for someone to join our US marketing team as the Associate Director , Product Marketing Owner - HCC / Ecosystem for the HIV Franchise. ... Global Marketing, Data & Analytics, Policy, Payer Marketing, Global Communications, Regulatory , Legal/ Compliance Partner with other Product Marketing Owners to… more
- Merck & Co. (North Wales, PA)
- …with International Pharmacovigilance community and external customers to ensure regulatory compliance for both expedited and periodic reports.Collaborate ... Collaborate with internal and external stakeholders with processes that ensure compliance with local and global PV regulations.Ensure that PV activities are… more
- Merck & Co. (Rahway, NJ)
- …pharmacokinetics modeling software (eg, Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product ... compliance mindset.Essential Knowledge, Duties & Responsibilities for the Director Include:Biopharmaceutics expertise supporting delivery of small molecule, peptides… more
- Insmed Incorporated (San Diego, CA)
- …Millennials™, and Best Medium Workplaces™ lists.OverviewJoin the Technical Operations team as Associate Director of MSAT where you will support pipeline programs ... represent Insmed Gene Therapy as subject matter expert during external and internal regulatory submissions and compliance inspections. Travel will be required to… more
- Merck & Co. (Rahway, NJ)
- …Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team… more
- Eisai, Inc (Raleigh, NC)
- …microbiological assays.Thorough technical understanding of analytical laboratory compliance requirements and regulatory expectations.Demonstrated understanding ... and approve relevant technical documents, such as change controls, regulatory submissions, deviations, validations, method transfers, APRs, etc. as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …that all employees are in compliance with all contract requirementsSupport the Associate Director Global Strategy and Operations and Head Global Strategy and ... of Global RD and PV QA organizational strategy in collaboration with the Associate Director Global Strategy and Operations and Head Global Strategy and… more
- Eisai, Inc (Louisville, KY)
- …with internal cross functional partners including but not limited to Associate Director Regional Marketing, Oncology Field Reimbursement Managers, and ... approved promotional clinical trials, patient access to medication, and regulatory / compliance guidelines.Strong knowledge of key laws and regulations… more
- Eisai, Inc (San Diego, CA)
- …with internal cross functional partners including but not limited to Associate Director Regional Marketing, Oncology Field Reimbursement Managers, and ... approved promotional clinical trials, patient access to medication, and regulatory / compliance guidelines.Strong knowledge of key laws and regulations… more
- The George Washington University (Washington, DC)
- I. JOB OVERVIEW Job Description Summary: The Director , Regulatory Oversight position reports to the Associate Provost Research Integrity and Compliance ... and resolve compliance , service and operational issues. The Director , Regulatory Oversight position responsibilities include overseeing the activities… more
- Fidelity TalentSource LLC (Boston, MA)
- …plus\u00A0Strong attention to detail and experience supporting a regulatory compliance program\u00A0\u00A0Strong analytical, organizational, and problem-solving ... promotes a culture of ethical conduct and commitment to compliance , regulatory and legal obligations.\u00A0 In this...offsite with maximizing time together in person to meet associate and business needs. Currently, most hybrid roles require… more
- Senior Living Communities (Myrtle Beach, SC)
- …required by state regulatory agencies. * Operates the SNF areas in compliance with all regulations from federal, state, or any other governmental agencies having ... over the campus and act as liaison between the campus and regulatory agencies. * Implements the administration of resident medications, assesses response to… more
