- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. SummaryThis position supports safety monitoring and risk management activities, provides insights on current ... clinical practice and guidelines, reviews and provides written assessments...position supports a senior physician in evaluating and mitigating safety signals as they arise. Additionally, this position works… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.SummaryThis position serves as the Clinical Safety Scientist Lead for a large, late-stage program or ... safety surveillance and risk management in partnership with Product Safety Lead(s), Clinical Safety Physician(s), and cross-functional team in support of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an equal opportunity employer including veterans and people with disabilities. SummaryThe Associate Director , Global Oncology Clinical Development (GOCD) ... generation (checklist, process map, etc.), change management and detailed analyses. The Associate Director , GOCD Functional Excellence must have excellent verbal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core ... Data Sheets (CCDS) for assigned products. This position drives/leads the maintenance of global labeling and associated documents (including cartons and external packaging in the US) for assigned Daiichi Sankyo products. This position ensures that draft… more
- Merck & Co. (Rahway, NJ)
- …enables gain of critical internal experience during scale-up of clinical supplies manufacturing, demonstration of new manufacturing technology/processes, training ... position is also responsible for implementing actions to meet Safety and Environment (S&E) and GMP requirements as well...pilot plant. The Facility Lead position reports to the Director of Operations/Head of SSO Pilot Plant and the… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. Summary The Associate Director is responsible for developing RWE strategies for assigned product(s) and ... #IND123 #LI-Remote Eisai Salary Transparency Language:The base salary range for the Associate Director , Global RWE (Real World Evidence), Global Medical Affairs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Manager role is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in...writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND.Lead the CRO and vendor selection… more
- Merck & Co. (Rahway, NJ)
- …regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Primary activities include, ... but are not limited to:Reports to Executive Director or Associate Vice President, General MedicineDevelops worldwide product regulatory strategy to optimize… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **Summary** This position serves as the Clinical Safety Scientist Lead for a large, late-stage program or multiple ... safety surveillance and risk management in partnership with Product Safety Lead(s), Clinical Safety Physician(s), and cross-functional team in support of… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **Summary** This position supports safety monitoring and risk management activities, provides insights on current ... clinical practice and guidelines, reviews and provides written assessments...position supports a senior physician in evaluating and mitigating safety signals as they arise. Additionally, this position works… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- … Director to join out Oncology Clinical Development department. The Associate Director Clinical Sciences leads in the development, evaluation, ... scientific integrity and interpretation of study data of a clinical development program. The Associate Director...and GCP guidelines as well as applicable SOPs regarding clinical safety + Possesses proficient scientific expertise… more
- J&J Family of Companies (Raritan, NJ)
- Associate Director , Clinical Pharmacology and Pharmacometrics (CPP) - 2406190600W **Description** Johnson & Johnson is recruiting for an ** Associate ... health for humanity. Learn more at https://www.jnj.com/ . The Therapeutic Area (TA) Clinical Pharmacology (CP) Associate Director role within Clinical… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . ** Associate Director , Industrial Hygiene - New Brunswick** The primary focus ... is to support Bristol Myers Squibb (BMS) as the Associate Director of Industrial Hygiene for the...Safety and Sustainability. This position reports to the Director of EHS for the New Brunswick site and… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Join Gilead and help create possible, together. **Job Description** ** Associate Director , Biostatistics** **Position Overview:** Biostatisticians at Gilead ... in efficiently achieving regulatory, scientific and business objectives. The Associate Director will be primarily responsible for... Research, Clinical Data Managers and other Clinical , Global Drug Safety , Regulatory and Project… more
- AbbVie (Florham Park, NJ)
- …(https://www.instagram.com/abbvieireland/) , YouTube and LinkedIn. Job Description Purpose: The Associate Scientific Director provides medical and scientific ... and provider interactions (HCP's, Patients and Payers); generation of clinical and scientific data (enhancing therapeutic benefit and value); educational… more
- The Mount Sinai Health System (New York, NY)
- … safety aspects of clinical research trial(s). Under guidance of the Associate Director of Research and Quality Outcomes, the CRA is responsible for ... The Clinical Research Associate is an integral...The Clinical Research Associate is an integral part of the research...collecting, assessing and processing Adverse Events (SAE) for safety reporting, CEC and DSMB of clinical … more
- Merck (Rahway, NJ)
- …enables gain of critical internal experience during scale-up of clinical supplies manufacturing, demonstration of new manufacturing technology/processes, training ... position is also responsible for implementing actions to meet Safety and Environment (S&E) and GMP requirements as well...pilot plant. The Facility Lead position reports to the Director of Operations/Head of SSO Pilot Plant and the… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …develop programming submission strategy, perform integrated analysis of efficacy and safety , generate submission data package, create TLFs to support submission QAs, ... perform ad-hoc and exploratory analysis requested by clinical team, and support agency response or potential Advisory...effective implementation of SDTM, ADaM and TLFs standard in clinical trial data analysis - Develop and maintain necessary… more
- Pfizer (New York, NY)
- …Proficiency with global regulatory guidance (especially ICH, FDA, and EMA) relevant to clinical and safety data + Comprehensive understanding of the drug ... + The Medical Writer (Senior Manager) creates documents pertaining to clinical studies and regulatory interactions, including (but not limited to) protocols,… more
- AbbVie (Madison, NJ)
- …interactions (Payers, Patients, Prescribers, and Providers); generation of clinical and scientific data (enhancing therapeutic benefit and value); ... (medical education, data, guidelines and value proposition); safeguarding patient safety (risk minimization activities / safety surveillance activities).… more
