- Catalent (New York, NY)
- …Global Nutritional & Beauty Business Development Team reporting to the Regional Director Beauty Softgels North America, and responsible for managing new business ... a difference. Catalent is committed to the health and safety of its employees, visitors and the customers and...of our recruitment and on-boarding processes to maintain everyone's safety . The Human Resources teams will communicate all necessary… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. Summary The Director , Clinical Safety , will be a product safety lead or part ... safety team, and be responsible for overall product safety strategy or specific areas of safety surveillance and risk management, and provide safety … more
- Tris Pharma (Monmouth Junction, NJ)
- …and team success.We have an immediate opening in our Monmouth Junction, NJ facility for a Director , Drug Safety . The Director , Drug Safety is responsible ... for planning, directing, coordinating and prioritizing activities of the product safety team and providing oversight of Pharmacovigilance (PV) vendors in all aspects… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in R&D as early as possible. This led us to create the Translational Patient Safety Senior Director position, which will have unique exposure to Daiichi Sankyo's ... new group within CSPV. He/she will spearhead developing a culture whereby safety is diligently considered prior to selecting promising candidates (DP0), allowing… more
- 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 ... function. This position supports a senior physician in evaluating and mitigating safety signals as they arise. Additionally, this position works with other CSPV… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve ... standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle of clinical development,...the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director , ESQL is responsible for all activities at the External Entity (EE) site associated with the manufacturing of company products ... all applicable regulatory requirements, regulatory filings and company policies.The Associate Director also ensures that effective and robust Quality systems are… more
- Merck & Co. (Rahway, NJ)
- …to the world.Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:Developing regulatory strategy for their ... single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Primary activities include, but are not… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. Job Summary The Medical Director will provide medical leadership for medical affairs strategy, planning and supportive ... tactics for assigned therapeutic area. Under the direction of the Senior Medical Director , this role will be responsible for working with key stakeholders to develop… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you.The Medical Director , US Medical Affairs provides medical leadership for medical affairs strategy, planning and ... communication/publication components of overall medical operating plan. The Medical Director provides strategic development, planning, implementation and oversight of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …employer including veterans and people with disabilitiesSummaryThe Associate Director , Global Oncology Clinical Development (GOCD) Functional Excellence supports ... (AESI) educational materialsThis role works cross-functionally to collect / update safety and treatment information that is ultimately provided to educate patients… more
- Eisai, Inc (Nutley, NJ)
- …following (which may have been gained concurrently): Supporting Regulatory and/or Safety functions in a global environment; Supporting Regulatory processes such as ... Publishing and Registration tracking; Working with Regulatory Planners, Publishers, Safety Officers, Case Processers, Medical Writers, Labelling authors and study… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at the study ... of data is suitable for regulatory submission. The Associate Director will have routine interaction with key internal and...writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND.Lead the CRO and vendor selection… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and ensures the study designs are scientifically sound, the efficacy and safety information meets regulatory requirements of the countries and Regions the drugs ... the drug project; Leads the planning and analysis of integrated efficacy and safety data; Review the relevant sections of the electronic common technical document… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... of protocol deviations- Discusses medical eligibility questions and answers safety questions (dose modifications, discontinuations, and management of adverse… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Collaborates with CSPV to ensure monitoring / reporting of AEs/SAEs, Reviews safety reports/data during study conduct, Provides and documents oversight of medical ... medical direction to MW for the CSR; Leads indication specific surveillance and safety summaries, such as Section 2.7.3 of eCTD.Study Strategy: Clinical Study Leader… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical Science (CS) Group Lead will ... charter, etc), clinical data review excellence with a focus on patient safety and data integrity, site scientific engagement, and HA responsesInteractions with the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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 labeling complies… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …oncology trials as well as submission-related activities, eg, integrated summary of safety (ISS) and integrated summary of efficacy (ISE)- Direct Project Support: ... Providing direct support to key studies in order to ensure sufficient planning of statistical deliverables from vendors as well as work by in-house statistical programmers- CRO / Vendor Oversight: Manages higher-level negotiations and provides oversight of… more
