- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Uses medical knowledge to aid the SMT's signal identification efforts. Safety Expert - Signal Evaluation: Assists manager in assessing new signals. Safety ... CSPV tasks such as single event level AE causality assessment . This position requires manager review and gains industry...of the NDA, CSR, and IB. May review any safety submissions for medical accuracy. Qualifications: Successful… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Review PlanAccountable for the assessment of protocol deviationsDiscusses medical eligibility questions and answers safety questions (dose modifications, ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Plan- Accountable for the assessment of protocol deviations- Discusses medical eligibility questions and answers safety questions (dose modifications, ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science (CS) Group Lead will ... and associated documents (writing of ICF, DM charter, response assessment charter, etc), clinical data review excellence with a...clinical data review excellence with a focus on patient safety and data integrity, site scientific engagement, and HA… more
- Merck & Co. (Rahway, NJ)
- …robust scientific methodology we collaborate to discover and develop the next medical breakthrough. Our Company's success is backed by ethical integrity, forward ... portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team… more
- Merck & Co. (Rahway, NJ)
- …facilities and robust scientific methodology we collaborate to discover the next medical breakthrough.Our team in Rahway, New Jersey, is seeking an exceptional ... enable and accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable… more
- Bristol Myers Squibb (Madison, NJ)
- …both at work and in their personal lives. Read more: careers.bms.com/working-with-us . ** Director , Medical Safety Assessment Physician (Immunology)** ... safety labeling support. . Lead process improvement projects. Assist the Medical Safety Assessment (MSA) TA Head/Lead in developing and maintaining… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …dynamic and experienced individual to join the **PS Strategic Operations** team as a ** Director , PS Medical Device Safety ** responsible for developing and ... ensure operational excellence through successful business partner collaboration. The Director , PS Medical Device Safety ...and PS Benefit-Risk Science teams to define process for safety assessment of device complaints, as well… more
- J&J Family of Companies (Raritan, NJ)
- Director , Medical Safety Officer (Neurovascular) - 2406209070W **Description** **Johnson & Johnson, is recruiting for a Director , Medical Safety ... we all belong.** The MSO role is to provide medical safety stewardship for Medical ...medical input/review to: Risk Management Reports, Product Issue assessment / Health Hazards Evaluations, Clinical Evaluation Reports, Product … more
- System One (Basking Ridge, NJ)
- Associate Director , Clinical Safety MD Pharma In New Jersey - Remote (no west coast, only EST or CST) 12 month contract | Up to $100/hr dependent on experience. ... MD is okay + 1-3 years of Pharmacovigilance (PV)/clinical safety experience in pharmaceutical drugs either from relevant work...phase. + Defines the risk component of the B/R assessment . Skills : + 1-3 years of Pharmacovigilance (PV)/clinical… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … safety sections of the NDA, CSR, and IB. May review any safety submissions for medical accuracy. **Qualifications:** Successful candidates will be able to ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- AbbVie (Florham Park, NJ)
- …supervision and guidance. Exercises judgment within well-defined practices and policies. Associate Medical Director Qualifications + Medical Doctorate (MD) ... be determined by the qualifications listed below. Purpose: The Associate Scientific Director , Psychiatry Pipeline role provides medical and scientific strategic… more
- AbbVie (Florham Park, NJ)
- …supervision and guidance. Exercises judgment within well-defined practices and policies. Associate Medical Director Qualifications + Medical Doctorate (MD) ... be determined by the qualifications listed below. Purpose The Associate Scientific Director provides medical and scientific strategic and operational input into… more
- AbbVie (Jersey City, NJ)
- …preclinical, clinical pharmacy, clinical development, and discovery + Works closely with Executive Medical Director to establish safety strategy for each ... set the strategy for key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans +… more
- AbbVie (Florham Park, NJ)
- …timelines, compliance requirements are factored into programs' scientific activities. Qualifications Medical Director Qualifications: + Medical Doctorate ... ( medical education, data and value proposition); safeguarding patient safety (risk minimization activities / safety surveillance activities). Works… more
- Danaher Corporation (New York, NY)
- …lives with diagnostic tools that address the world's biggest health challenges The Medical Director , Scientific and Medical Affairs position for Beckman ... business stakeholders in the laboratory diagnostics community and providing medical /clinical input into Safety , New product development...and Scientific Affairs team and report to the Senior Director , Medical and Scientific Affairs. If you… more
- Danaher Corporation (New York, NY)
- …applied to digital pathology research and practice. + Experience with risk management / safety assessment in medical device or biopharmaceutical industry. + ... with diagnostic tools that address the world's biggest health challenges. The Medical Director , Companion Diagnostics and Advanced Assays for Leica Biosystems… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …real-world evidence, and creating hope for all facing illness. As a senior member of Medical Science, the Senior Director , Medical Science - Early Stage will ... therapeutic areas involving complex indications including rare disease/orphan conditions. The Senior Director , Medical Science - Early Stage will be responsible… more
- AbbVie (Florham Park, NJ)
- …Florham Park, NJ preferred. Will consider remote candidates. Purpose: The Scientific Director provides medical and scientific strategic and operational input ... medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …as required for senior management on a global basis. + Support regulatory safety reporting for clinical programs: SAE assessment , queries and follow-up, annual ... is a research-driven pharmaceutical company that has tirelessly pursued medical breakthroughs with global reach. MTPC has discovered and...As a senior member of MSLS Development, the Senior Director , MSLS will lead the full development team in… more