- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary This position works with the Director , Clinical Study Startup to establish the strategy driving ... where appropriate and escalate any complex problems to the Director , Clinical Study Startup.This position... protocols to ensure consistency in safety requirements across studies related to a similar compound. Develops and oversees… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL) Study Planning and Execution: Provides ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and control of Clinical Project Budget in support of Phase I-III clinical studies .Partner with Project Management, Clinical Operations and other ... global business partners to develop budgets and analytics for ongoing and new pipeline studies in support of the annual process of extracting the optimal value out… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …also contribute to strategic planning and provide scientific and strategic insights at the study team level. The Associate Director of Regulatory Writing ... centered around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a... regulatory documents include, but are not limited to, clinical study reports, investigator brochures, regulatory briefing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex ... studies including study design, protocol development, CRF review, SAP development, analysis...review. Acts as main statistical contact for the assigned studies and projects. Provides guidance to study … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a comprehensive understanding of the functional roles within Pharmacovigilance and Clinical TrialsAbility to extract configurable data fields from a study ... protocolProficient in FDA regulations supporting the submission of adverse events for post-marketing and investigative drugs. Understanding of global regulations preferredGood knowledge of Good Documentation PracticesEffectively manages shifting priorities;… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and timelines for assigned studies and escalates issues to the Associate Director of Medical Coding to gain resolution. Functional Expertise: Study ... coding services for assigned programs, collaborating with program teams, clinical safety and pharmacovigilance, CROs, and partners to ensure...DS Medical Coding synonym list update requests to the Associate Director of Medical Coding to ensure… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** ** Associate Director , Clinical Pharmacology - Virology** **_*This is ... and study sites to implement and monitor clinical pharmacology studies . Addresses clinical ...regulations, ICH guidelines, and GCP governing the conduct of clinical studies . Has significant knowledge of pharmaceutical… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **Summary** This position works with the Director , Clinical Study Startup to establish the strategy driving ... where appropriate and escalate any complex problems to the Director , Clinical Study Startup. This... protocols to ensure consistency in safety requirements across studies related to a similar compound. Develops and oversees… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …key metrics and Key Performance Indicators (KPIs) across studies and within clinical program(s) to track study progress. + Manages all aspects of Quality ... quality, timelines and resources related to the conduct of clinical research studies in accordance with applicable...with senior level management, external vendors, collaboration partners and clinical study personnel for clinical … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Develops biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL) + Study Planning and Execution: ... Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. **Responsibilities** + Study Strategy:… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …City, CA. This is NOT a remote position **RESPONSIBILITIES:** + In partnership with Clinical Program Manager or Associate Director , provides guidance and ... Plan, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans, Clinical Study Report + Coordinates data review to support… more
- Bayer (Whippany, NJ)
- …biopharmaceutical industry, clinical and/or academic work experience; + Understanding of clinical study design, analysis and interpretation as well as the ... to make a real difference, there's only one choice.** ** Associate Medical Director , US Medical Affairs Oncology,...principles of observational studies and health economics/ outcomes research; + Proven record… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex ... studies including study design, protocol development, CRF review, SAP development, analysis...review. Acts as main statistical contact for the assigned studies and projects. Provides guidance to study … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …also contribute to strategic planning and provide scientific and strategic insights at the study team level. The Associate Director of Regulatory Writing ... centered around rare diseases and immune disorders. **Summary** The Associate Director of Regulatory Writing is a... regulatory documents include, but are not limited to, clinical study reports, investigator brochures, regulatory briefing… more
- AbbVie (Florham Park, NJ)
- …on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Purpose: The Associate Director in CMC Statistics is responsible for providing statistical ... is determined by years of experience, education, and relevant experience. Qualifications for Associate Director , Statistics (CMC): + MS (with 10+ years of… more
- Bristol Myers Squibb (Berkeley Heights, NJ)
- …every treatment we pioneer. Join us and make a difference. **Purpose** The Associate Director , Biostatistics is a core member of cross-functional development ... trial design, analysis planning, study results presentation and interpretation, clinical study report authoring, regulatory submissions and publications. +… more
- AbbVie (Florham Park, NJ)
- …level will be determined by the qualifications listed below. Purpose The Associate Scientific Director provides medical and scientific strategic and operational ... practice standards, including regulatory guidelines to meet customer needs. Qualifications Associate Scientific Director Qualifications + Bachelor's Degree in… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and control of Clinical Project Budget in support of Phase I-III clinical studies . Partner with Project Management, Clinical Operations and other ... global business partners to develop budgets and analytics for ongoing and new pipeline studies in support of the annual process of extracting the optimal value out… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …and unique opportunity for a medical writer to join our dynamic team at the Associate Director level. You will author a wide range of regulatory documents ... a wide variety of documents of all types and complexities, such as clinical study reports (CSRs) (all phases), investigator's brochures, CTD summaries/overviews,… more
