- Insmed Incorporated (Bridgewater, NJ)
- … safety documentation in collaboration with the Executive Safety Committee.Provides medical expert safety review input into all critical documents for ... Executive Director (ED) will provide leadership to the DSPV Medical Safety Team. He/She will be accountable...IBs, IMPDs, clinical research reports, INDs, CTAs). Leads the Safety Review Team(s) for assigned products and… more
- Merck & Co. (North Wales, PA)
- …patient safety and clinical relevance elements in a customer-centric approach.- Review all medical information resources and standard response documents ... company products as it relates to deletions, divestitures, and supply issues.Accountabilities: Medical Review of US and Global Promotional MaterialsProvide… more
- Uline (Columbus, OH)
- …and monitor safety goals.Take part in new product / process review , including process hazard analysis.Participate on Uline's Safety Committee. Review ... Columbus, Ohio Safety Coordinator Join Uline as we expand our...packages weighing up to 50 - 70 lbs. BenefitsComplete medical , dental, vision and life insurance coverage, Flexible Spending… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …oversight and management of all contract and vendor related activities in Patient Safety including, but not limited to, contract review and vendor management ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk...requirements. Relationships This position reports to the Director, Case Review & Compliance Reporting within Patient Safety .… more
- Merck & Co. (North Wales, PA)
- …worldwide to engage on statistical issues associated with the ongoing aggregate review of safety .-Prepare oral or written reports to effectively communicate ... analysis methods fundamental to effective pharmaceutical R&D.- The Clinical Safety Statistics (CSS) group within BARDS supports proactive assessment, transparent… more
- Novo Nordisk Inc. (Boulder, CO)
- …NN TRU Boulder facility complies with all applicable environmental, health and safety regulations. Relationships Reports to Senior Specialist EHS at US headquarters ... valued vendors. Essential Functions Manage the maintenance and implementation of safety programs, compliance plans, and initiatives with primary focus on… more
- Tris Pharma (Monmouth Junction, NJ)
- …and/or leads, key Drug Safety activities including, but not limited to: safety data review , signal detection, risk communication including safety ... immediate opening in our Monmouth Junction, NJ facility for a Director, Drug Safety . The Director, Drug Safety is responsible for planning, directing,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …writing minor safety sections of the NDA, CSR, and IB. May review any safety submissions for medical accuracy.Qualifications: Successful candidates will ... relevant medical topics, and supports PV Operations' medical review function. This position supports a...medical knowledge to aid the SMT's signal identification efforts. Safety Expert - Signal Evaluation: Assists manager in assessing… more
- sweetgreen (Columbus, OH)
- …through performance metrics, tools, and accountability Uphold food quality and safety standards; ensure production consistency and regulatory compliance Execute on ... Experience in fast casual restaurant chains Regional Manager's Food Safety Certification (ServSafe Manager's Certification) About our sweetlife: Competitive base… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …trials, post-marketing and other relevant sources for the prompt identification of safety signals. Review and evaluate serious adverse event reports from ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...around rare diseases and immune disorders.Summary The Director, Clinical Safety , will be a product safety lead… more
- Eisai, Inc (Nutley, NJ)
- …and their staff regarding AE's from clinical trials. 30%Assist in projects requiring review and assessment of medical information obtained or related to adverse ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides...event reports received for assigned product, including the timely review and distribution to co-marketing partners and Eisai affiliate… more
- Eisai, Inc (Nutley, NJ)
- …grant reviews or other internal key business processes. Responsible for approval of medical and scientific content of Regulatory, Safety , Scientific Affairs, ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides...including (but not limited to) CRC, scientific communications, publication planning/ review , advisory boards, health outcomes plans, MSL activities, speaker… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …generation strategies and activities as part of the GMA Plan. Provides medical review of expanded access programs (EAP) and, investigator-initiated studies ... develop, review , and align on key scientific communications and medical information response documents within legal and compliance regulations. Leads internal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …generation strategies and activities as part of the GMA Plan. Provides medical review of expanded access programs (EAP) and, investigator-initiated studies ... develop, review , and align on key scientific communications and medical information response documents within legal and compliance regulations. Leads internal… more
- Taiho Oncology (TX)
- …Fulfill Pharmacovigilance responsibilities as defined in the pharmacovigilance SOPs related to medical inquiries and drug safety information. Use medical ... Medical Science Liaison Texas, USA Virtual Req #330...Investigator-Initiated Trials (IITs) and HCP initiated projects. Facilitate the review and follow-up of submitted IITs. Assist with Taiho… more
- Option Care Health (Dublin, OH)
- …Description: Job Responsibilities:Provides clinical operations support to locations, including ongoing review and update of policies, in the areas of therapeutics, ... caregivers to schedule a delivery and determine supply needs. Picks and packs medical supplies and medications to fill patient orders and confirms delivery tickets… more
- Eisai, Inc (Nutley, NJ)
- …grant reviews or other internal key business processes. Responsible for approval of medical and scientific content of Regulatory, Safety , Scientific Affairs, ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides...including (but not limited to) CRC, scientific communications, publication planning/ review , advisory boards, health outcomes plans, MSL activities, speaker… more
- Catalent (Philadelphia, PA)
- …Quality Assurance Document Control individual is responsible in preparing customer files, review and approve batch records, and release batch records and finished ... to our customer's quality assurance groups for batch record review and release. The Quality Assurance Document Control manages...through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. The… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... of this job is to oversee statistical vendor deliverables, perform programmatic review of analysis datasets and Table, Listing, and Figures (TLFs) generated by… more
- Catalent (Manassas, VA)
- …Assurance team with special projects as required. Comply with SQF, Food Safety Plan (HACCP), and Food Quality Plan (FQP) standards.Shift: 2nd Monday-Friday 1PM-9PM. ... numbering, and organization of all related documents: MMRs, specifications, BPRs, Food Safety and Quality Plans, and any other documents as required.Manage the… more
