- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. Summary The Manager, Regulatory Affairs - Regulatory Project Management (RPM) provides planning and ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...coordination supports for global and US regulatory activities. The Manager RPM is responsible for supporting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Supervise designated personnel. Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop ... About the Department The Clinical, Medical and Regulatory (CMR) department at...positive rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …company's growth, thereby accomplishing corporate goals.Responsibilities:Develop and implement US regulatory strategy for assigned project (s). Strategize and ... global project team meetings (development and/or marketed products); provide regulatory support and guidance and manage day-to-day regulatory activities.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disclosure for collection, retention, testing and retesting of samples Project Team Participation: Provide device-specific regulatory insight/guidance during ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Aequor (TX)
- …Actively contribute to the delivery of internal training and guidance to Site Regulatory Assessors on EU Medical Device Significant Change Notification reporting ... Job Description: Must Haves: Must have Medical Device experience. (Not Pharma) European MDR Experience...requirements Support the implementation of project related " regulatory excellence" activities as part… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … regulatory strategy for assigned development projects. Represents Daiichi Sankyo's regulatory group in internal and external development project meetings. ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- BioAgilytix (Durham, NC)
- …you enable life-changing, life-saving therapeutics to the patients who need them.The Regulatory Affairs Manager is responsible for coordinating the regulatory ... for Medical Devices, ISO 13485, FDA and (New) EU Medical Device requirementsCE Mark product certifications experienceDemonstrated project coordination and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …annual performance cycle. Relationships Reports to Executive Director or Vice President Medical Affairs . Has direct supervisory responsibility for field based ... About the Department The Clinical, Medical and Regulatory (CMR) department at...and other NNI units / personnel. Organized Provider Accounts, project and team leading responsibilities for FMA; contributes to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …solutions and efficiencies. Key internal stakeholder relationships include Scientific Communications, NNI Medical Affairs , Global Medical Affairs , Health ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at...Global R&D, US Competitive Intelligence, Managed Markets, Clinical Insights, Medical Affairs , Scientific Center of Excellence) and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Gather business requirements for reporting and analyticsEngage with key stakeholders, including Regulatory Affairs teams and cross-functional project team ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible… more
- Merck & Co. (North Wales, PA)
- …of relevant regulatory guidelines and compliance requirements pertaining to Medical Affairs operations, and, preferably, experience in navigating ... degree in life sciences, business, or healthcare + 5 years of relevant Medical Affairs experience (eg, Knowledge Management, Medical Operations) within… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … project teams, including Clinical Development, Clinical Operations, Biometrics, and Regulatory Affairs personnel to manage preparation of the written ... writing and will provide leadership on local and global project teams. This role will be a senior member...12 years of relevant experience Minimum of 10 years clinical/ regulatory medical writing experience in a pharmaceutical,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both internal and ... Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams to deliver and drive...resolve clinical development problems Work with the larger Global Project Team to deliver excellent medical support… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Medical & Science, Clinical Pharmacology, Biostatistics, Clinical Operations, Regulatory Affairs , Global Safety, Data Management, and Non-clinical ... you ready to make a difference?The Position The Senior Medical Writer works closely with cross-functional project ...7+ years of relevant experience Minimum of 5 years clinical/ regulatory medical writing experience in a pharmaceutical,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …advice to the CSPV and key business function and collaborate with RD and Medical Affairs Quality to provide clinical safety QA advise wherever necessary. Ensure ... implementation of the quality strategy in close alignment with the CSPV and Medical Affairs business strategy.Monitor and track implementation and break-down of… more
- Merck & Co. (Rahway, NJ)
- …of labeling experience or relevant experience in the pharmaceutical industry (eg, Medical Affairs , Regulatory Affairs , Clinical, Pharmacovigilance).- ... CCPPI, CCIFU) and US labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance of the EU Labeling and other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …project areas such as the clinical supplies organization, Reg Operations, Medical Affairs and labelling.- Participates in meetings with Health Authorities. ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...guidelines and assists in educating the organization on evolving Regulatory Affairs CMC (RACMC) issues and regulations… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …improvements in medical review processes and is also an integral member of the Medical Affairs Team. This position plays a key role in driving a unified ... project owners. Partner with colleagues responsible for PGC medical review to ensure seamless progression of submissions from...to junior colleagues- Serve as integral member of the Medical Affairs Teams for assigned TA.Proactively lead… more
