- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to regulatory process optimizations on relevant topics.Responsibilities- Supports CMC regulatory compliance activities for portfolio biologics to meet US, ... research areas centered around rare diseases and immune disorders.Summary The Associate Director, RACMC Portfolio Products, will be responsible for regulatory… more
- Merck & Co. (Millsboro, DE)
- …and unregulated species including chickens, turkeys, dogs, cats, rabbits, and rodents.Assure compliance with all federal and state regulatory requirements for ... Delaware seeks to add an Attending Veterinarian in the role of Associate Director.This position will have overall responsibility for oversight and administration of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Medical teams as well as alliance partners, promoting a cohesive team approach. Regulatory and Safety Compliance : Understand study conduct from supply chain/drug ... research areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of Global Medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Must be well-versed in pharmaceutical brand marketing, pharmaceutical industry, legal, compliance and regulatory , convention industry to provide recommendations, ... research areas centered around rare diseases and immune disorders.Summary: The Associate Director, Regional Marketing Conventions & Field Programs will be… 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
- Merck & Co. (Lower Gwynedd, PA)
- …working to implement assays. Ensure assays are developed and executed in compliance with applicable regulatory guidance. Develop assay protocols, qualification ... developing and expanding your career.We are seeking a highly motivated Associate Principal Scientist to join the Department of Pharmacokinetics, Dynamics,… more
- Aequor (Thousand Oaks, CA)
- …adaptable to changing priorities and requirements ? Demonstrate understanding of regulatory requirements, safety guidelines and factors impacting compliance ? ... and laboratory logbooks. Preferred Qualifications ? Ability to adhere to regulatory requirements, written procedures and safety guidelines ? Ability to evaluate… more
- Merck & Co. (Durham, NC)
- …for the company; uses this knowledge in own work Understands and applies regulatory / compliance requirements relative to their role Basic conceptual knowledge ... with our incredibly high standards of quality and meets all regulatory requirements.- Partnering across our internal manufacturing facilities, external contract… 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
- Novo Nordisk Inc. (WA)
- …research (patient safety, rights and wellbeing; data reliability; scientific integrity; regulatory and process compliance ) for monitoring and site management ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… 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. (North Wales, PA)
- …Global Marketing, Data & Analytics, Policy, Payer Marketing, Global Communications, Regulatory , Legal/ Compliance Partner with other Product Marketing Owners to ... are currently recruiting for someone to join our US marketing team as the Associate Director, Product Marketing Owner - HCC / Ecosystem for the HIV Franchise. -Ideal… more
- Aequor (South San Francisco, CA)
- …reliable data and/or Ensures that contracted studies are conducted in compliance with the respective protocol and applicable guidelines and regulations. ... experimental difficulties ? Contributes to internal/external reports, papers, presentations, regulatory documents, invention disclosure submissions and/or patents ? Participates… more
- Aequor (Thousand Oaks, CA)
- …reliable data and/or Ensures that contracted studies are conducted in compliance with the respective protocol and applicable guidelines and regulations. ... experimental difficulties ? Contributes to internal/external reports, papers, presentations, regulatory documents, invention disclosure submissions and/or patents ? Participates… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The incumbent is responsible for… more
- Insmed Incorporated (San Diego, CA)
- …represent Insmed Gene Therapy as subject matter expert during external and internal regulatory submissions and compliance inspections. Travel will be required to ... and Best Medium Workplaces™ lists.OverviewJoin the Technical Operations team as Associate Director of MSAT where you will support pipeline programs that… 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
- Merck & Co. (Rahway, NJ)
- …pharmacokinetics modeling software (eg, Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product ... biopharmaceutics technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory … 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 ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
