- Novo Nordisk Inc. (Plainsboro, NJ)
- …Program Management team to ensure vendor compliance with all quality/ safety requirements; educates on process requirements Partners with compliance and Program ... future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Job SummaryThe position develops the global safety strategy, oversees risk management activities, and recruits and develops ... successfully a team of physicians and scientists, accountable for safety surveillance and risk management activities for... through complete submission process & in submission of data to health authorities.Proven strong leadership in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …external-facing agreements including, but not limited to, Master Service Agreements (MSAs), Safety Data Exchange Agreements (SDEAs) and Statement of Works ... most diverse and collaborative groups within the organization. From health -care-provider interactions and developing and implementing regulatory strategies with the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Partnerships and contracts including vendor outsourcing agreements, PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). Maintains oversight of DSI ... maintain compliance with global PV regulations for individual case safety reporting, periodic reporting and risk management ....and the contractual obligations that govern the exchange of safety data between partners in relation to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our ... Create material to educate nurses, doctors, and other HCPs about obesity management , covering topics such as disease education, treatment guidelines, and best… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as well as management of adverse events based upon approved Safety Management Team (SMT) materialsSupports overall program safety reporting ... the development of clinical sections of study-level documents (eg, protocol, amendments) of safety data to mitigate risk to trial participants for the assigned… more
- Merck & Co. (North Wales, PA)
- …and standard response documents containing product safety , tolerability and efficacy data . Interact with Health Care Professionals who request a live ... safety and efficacy, and when required, interact with Health Care Provider to help answer unsolicited medical information...and review specialist Actively contact and interact with Risk Management Safety Team(s) when requiredAct as subject… more
- Merck & Co. (Rahway, NJ)
- …in developing analysis and reporting deliverables for clinical trial projects ( data , analyses, tables, graphics, listings)Strong project management skills; ... data preprocessing, filtering, and manipulation;Programming expertise with clinical endpoint data (efficacy and safety ) and pharmacokinetic data (raw… more
- Insmed Incorporated (San Diego, CA)
- …study teams, including:Collaborate with team members in the review and development of Data Management activities including data cleaning, eCRFs, edit checks, ... requiredStrong medical writing and presentation skillsBasic understanding of biostatistics and data management Ability to read, analyze and interpret common… more
- Merck & Co. (Millsboro, DE)
- …activities within the department, and also within support fields such as Environment, Health and Safety .Trains and guides other employees and / or ... Job DescriptionWelcome to our team:Our Animal Health Manufacturing teams are the people that make...products. We work in the manufacturing plants with a " Safety First, Quality Always" mindset striving for continuous improvement.-… more
- Insmed Incorporated (San Diego, CA)
- …with external experts to gather inputOrganize scientific advisory board meetings and data safety monitoring committee meetingsMaintain a high level of clinical ... Services, Regulatory Affairs, R&D, and Legal) and external (healthcare professionals, data safety monitoring boards, patients, advocacy groups, etc.)… more
- Merck & Co. (Rahway, NJ)
- …describe the methodology to be programmed; applying statistical terminology and clinical data management concepts; CDISC SDTM and ADaM standards; ensuring ... Job DescriptionResponsibilities:Utilize big data to analyze the safety and...benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads the ... for assigned Daiichi Sankyo products ensuring compliance with all applicable Health Authority (HA) regulations and guidelines, internal company procedures and… more
- Twist BioScience (South San Francisco, CA)
- …Experience with vendor management and the implementation of the corporate safety program Experience with Environmental Health & Safety programsAbout ... conducting "walk-throughs" of site to ensure compliance with local health and safety regulations Model company ...the world for the better. In fields such as health care, agriculture, industrial chemicals and data … 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 ... best science at first filing for parenteral development processes for human health while ensuing a phase appropriate approach during early development.The incumbent… more
- Merck & Co. (North Wales, PA)
- …an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM standardsExperience ... drugs and vaccines for the benefit of patients and global human health . This position supports statistical programming activities for late stage drug/vaccine… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data ... complies with all applicable regulations and guidelines and with Company Core Data Sheets and manages deviations. This position interacts across the RA function… more
- Merck & Co. (Rahway, NJ)
- …project planning, resourcing, progress reporting, troubleshooting and people management .Serve as the scientific/technical mentor for junior staff.- Provide ... timely and accurate information and status updates to project sponsors and management .May be responsible for managing large multifaceted projects as the leader of… more
- AUROBINDO (Durham, NC)
- …shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees. Position requires working in the ... portfolio very quickly. The Aurolife family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality… more
- Merck & Co. (North Wales, PA)
- …an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM standardsDemonstrated ... experience in developing analysis and reporting deliverables for R&D projects ( data , analyses, tables, graphics, listings)Strong project management skills;… more
