- Merck & Co. (Upper Gwynedd, PA)
- …to and be a valued co-strategist on asset cross-functional meetings: Franchise Teams, Clinical , Outcomes Research, Risk Management , and Commercial Asset ... clinical and scientific value requirements for most geographies Management Participate during relevant Global Medical Affairs Team (GMAT) (including Regional… more
- Merck & Co. (North Wales, PA)
- …required to have five years of safety experience or related areas such as Clinical Risk Management , Clinical or RegulatoryPreferred:Strong knowledge base ... other project or perform any other task deemed appropriate by management .Education:Bachelor's degree or master's degree in health care/pharmaceutical related field… more
- Novo Nordisk Inc. (WA)
- …and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) principles and tools; executes activities ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...integrity; regulatory and process compliance) for monitoring and site management activities. Takes ownership to deliver upon near-term North… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are ... Job Summary: The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in adherence to Good … more
- Merck & Co. (Rahway, NJ)
- …writing, and presentation skillsEducation/ExperienceBachelor's Degree +9 years of pharmaceutical, clinical drug development, project management , and/or medical ... field experienceOR Master's Degree +6 year of pharmaceutical, clinical drug development, project management , and/or medical field experienceOR PhD/PharmD Degree… more
- Merck & Co. (Upper Gwynedd, PA)
- … Specialist The Clinical Specialist position is a combined position of clinical scientist and study management duties supporting one or more clinical ... : Education Minimum Requirement: Bachelor's Degree +1 years of pharmaceutical, clinical drug development, project management , and/or medical field experience… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders. SummaryThis position supports safety monitoring and risk management activities, provides insights on current clinical practice and ... this position works with other CSPV staff and cross functional Safety Management Team (SMT) members, often handling straight-forward CSPV tasks such as single… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Data Management , Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/ Risk Management , Quality ... Daiichi Sankyo (DS) in the US, EU, Japan, and other global sites. These business functions include: Clinical Operations, Clinical Development, Biostatistics and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Data Management , Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/ Risk Management , Quality ... Daiichi Sankyo (DS) in the US, EU, Japan, and other global sites. These business functions include: Clinical Operations, Clinical Development, Biostatistics and… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development, Ophthalmology will focus on driving strategy, development, and ... life-cycle management activities in the Neuroscience & Ophthalmology Therapeutic Area....organization therefore requiring someone who has built and lead clinical development plans from the ground up. They will… more
- Merck & Co. (North Wales, PA)
- …Data Management & Standards (GDMS) is responsible for ensuring that all clinical data management products and services are effectively delivered with high ... case processing, data standards and platform governance. Primary Responsibilities: Ensures Clinical Data Management products and services are delivered to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Project Management Office and Business Excellence (PMOBE) sub-function within Clinical Safety and Pharmacovigilance (CSPV). PMOBE is the strategic planning and ... through meeting management , development plan/timeline management , scope management , stakeholder management , risk /issue management , finance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a primary source of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external ... needed for maintenance of product licenses (eg, Core Data Sheet generation/revision; clinical benefit- risk assessments for license renewals, responses to Health… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a primary source of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external ... needed for maintenance of product licenses (eg, Core Data Sheet generation/revision; clinical benefit- risk assessments for license renewals, responses to Health… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …tailored for AEs from end-to-end: understanding predisposing non- clinical and clinical factors, diagnosis, effective management during clinical trials ... of Functional Excellence, across key functions to improve the benefit- risk in patients treated within the oncology compounds throughout...remains top of mind in the context of patient management in the clinical trial setting and… more
- Merck & Co. (Rahway, NJ)
- …related drug/vaccine projects in Late Development Statistics.Lead the interaction with Clinical , Regulatory, Statistical Programming, Data Management , and other ... these analyses.Prepares oral and written reports to effectively communicate results of clinical trials to the project team, Company Management , regulatory… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Update Reports (DSURs), periodic SUSAR reports, Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) according to implementation plans or as ... Coast Development Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs, Data Management , Biostatistics, Non-… more
- Aequor (Thousand Oaks, CA)
- …sales, to ensure supply chain activities align with business objectives. Compliance and Risk Management : Ensure all supply chain activities comply with relevant ... and supply of Pre- Clinical and Phase I Clinical Programs. The position requires project management ...supply chain activities align with business objectives. Compliance and Risk Management : Ensure all supply chain activities… more
- Merck & Co. (Rahway, NJ)
- …policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate ... opportunity is fast paced and contributes to the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the development of robust compositions,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Update Reports (DSURs), periodic SUSAR reports, Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) according to implementation plans or as ... Coast Development Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs, Data Management , Biostatistics, Non-… more
