- Daiichi Sankyo, Inc. (Bernards, NJ)
- …creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging ... centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic… more
- Eisai, Inc (Nutley, NJ)
- …least 12 years industry experience with a minimum of 10 years direct Regulatory Affairs experience in the biotech/biopharmaceutical industry. Education area of ... provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …key markets (Required)2 or more years with experience coordinating and managing regulatory audits and inspections, incl. CAPA management (Prefered). Travel: ... creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …years pharmaceutical industry experience and 4+ years direct or related CMC regulatory experienceSuccessful track record in preparation, management of review and ... creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging ... electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards.… more
- Merck & Co. (Durham, NC)
- …insights.Assure completion of required reports to site, divisional and/or corporate management and regulatory agencies.Manage budgetary & capital needs to ... the company to make a positive difference in health care and have a deep sense of responsibility towards...Risks, Multi- Management , People Leadership, Physical Sciences, Production Management , Project Management , Regulatory Compliance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Practice and regulatory compliance in such arrangements. Contribute to the management of PV Regulatory Intelligence (PVRI) and dissemination across CSPV ... contracts. Organize and conduct periodic review of contract quality and adherence PV Regulatory Intelligence:Contribute to the management of PV Regulatory … more
- BioAgilytix (Durham, NC)
- …technical concepts clearly and work cross-functionally to align data management goals with BioAgilytix's operational and regulatory requirementsDemonstrated ... that boost lab productivity and keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a foundational data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …data review and cleaning, database lock), to ensure data quality/integrity and regulatory complianceEnsures that Data Management Plans are consistent and ... stakeholders (eg, advisory committees and integration teams).Serves as the Data Management leader representing R&D during regulatory inspections and internal… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …training, and finance teams to ensure alignment with business objectives and regulatory requirements. Essential Functions Brand/Therapy Area Management o Support ... you ready to experiment with us? The Position The Senior Manager Health Care Professional Marketing will be responsible for supporting the development and execution… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our Research ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Eisai, Inc (Nutley, NJ)
- …provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through ... hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible for the planning and execution of Global Medical Affairs/MSL… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...difference? The Position Position provides field coaching, mentorship and management to the field-based Medical Liaisons, and develops and… more
- Eisai, Inc (Raleigh, NC)
- …provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through ... is responsible for executing core quality assurance functions, supporting regulatory inspections, and collaborating with internal and external stakeholders to… more
- Eisai, Inc (Nutley, NJ)
- …provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through ... opinion leaders, advisors as well as US and EU regulatory bodies in order to conduct Phase I, Phase...and providing oversight of clinical programs.Demonstrated experience in stakeholder management , vendor management , budget planning & resource… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging ... ensuring the execution of a risk-based audit program and effective CAPA management resulting from audits, health authority inspections across the organization and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …is responsible for leading the enterprise approach to achieving our patient care goals and financial objectives, devising and delivering transformative patient and ... The focus includes leading a team dedicated to HCP activation through education and awareness, fostering KOL partnerships, and cultivating lasting relationships with… more
- City of Spring Hill Kansas (Spring Hill, KS)
- …Hill, Kansas seeks a highly qualified, dynamic professional to provide leadership, management and direction on all the various components of planning, economic and ... policies, procedures as well as capital and special project management that align with the City's priorities? If so,...We also offer other great benefits such as vision care allotment, paid leave, holiday pay, KPERS retirement and… more
- Eisai, Inc (Nutley, NJ)
- …provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through ... Functions /Key Responsibilities: Lead the go-to-market/expansion strategy for Primary Care in AD. Collaborate with Sales Leadership, Operations, and SOC… more
- Eisai, Inc (Nutley, NJ)
- …Influence, Critical Thinking & Business Agility, Drafting and Negotiation, Industry/ Regulatory Knowledge, Legal & Reputational Risk Management , Legal Knowledge, ... provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through… more
