- Aequor (Thousand Oaks, CA)
- …remote schedule and be available at the committed times. Qualities/characteristics the hiring manager is looking for in candidates to work best with their team: ... go-getter, detailed oriented, customer service oriented Things the hiring manager is looking for when reviewing resumes that stand...(ie GxP, SOX) High attention to detail Understanding of clinical study conduct Ability to operate in a team… more
- Tris Pharma (Monmouth Junction, NJ)
- …globally. We have an immediate opening in our Monmouth Junction, NJ facility for a Senior Manager , Business Development.The primary role of the Senior ... portfolio of best-in-class ADHD medicines and an exciting pipeline of clinical -stage programs across Pain, Psychiatry, and Neurology. Our proprietary technologies… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine ... US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role...for Operational Study Strategy. This position may require the Sr . CSM to take the role of both operational… more
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. Job Summary The Senior Manager , Translational Science Biostatistics will be expected to work independently with ... evaluate biomarkers across programs, as well as the study statistician for clinical studies. As the statistical lead for biomarker development, this individual… more
- Eisai, Inc (NJ)
- …If this is your profile, we want to hear from you. Job Summary The Senior Manager , Medical Writing will be the designated Lead Medical Writer for approximately ... system#LI-HC1#IND-123Eisai Salary Transparency Language:The base salary range for the Senior Manager , Medical Writing is from :126,300-165,800Under current… more
- Eisai, Inc (Nutley, NJ)
- …make a difference. If this is your profile, we want to hear from you. Senior Manager , US Alzheimer's Strategy and Lifecycle Planning Marketing will assist with ... contribute to and participate within a diverse teamDemonstration of strong clinical aptitudeComplex launch experience, and an ability to communicate the… more
- Merck & Co. (Rahway, NJ)
- …to achieve new milestones in global healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical Development, and ... Clinical Supply across all modalities. We are interdependent across...their whole self to work.Within DSCS, the Digital Program Manager will advance the purpose and aspiration of our… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the Project Management Office and Business Excellence (PMOBE) sub-function within Clinical Safety and Pharmacovigilance (CSPV). PMOBE is the strategic planning and ... within CSPV that partners with various stakeholders across the organization. The Manager of PMOBE supports CSPV projects and business process optimizations and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …designated personnel. Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/ Sr . Manager Regulatory Affairs. Develop and maintain ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...Essential Functions Compile and submit responses to FDA communications. MANAGER , THERAPEUTIC AREA: Compile, submit and maintain applications (IND,… more
- Novo Nordisk Inc. (Stamford, CT)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific… more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support ... Investigations, Deviations, Complaints, etc. The focus of each QA Manager may be dependent upon the needs of the...may oversee a staff from five to ten including Sr QA Technical Reviewers and QA Product Managers. Responsible… more
- Merck & Co. (Rahway, NJ)
- …Quality Operations Lead (CQOL) and Head of Clinical Quality Operations, the Clinical Quality Operations Manager (CQOM) is accountable for the execution of ... Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide...Escalate potentially significant inspection findings/compliance risks/impact to our Company Senior Management. Develops the inspection management plan for each… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of studies within the clinical trial portfolio. Relationships Reports to a Senior Manager (or above) within North America Clinical Development (NACD). ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...within the Trial Management (TM) function of North America Clinical Operations (NACO). Takes ownership to position & deliver… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... difference? The Position The CMR Business Planning & Strategy Manager will be responsible for facilitating the creation and...and resource strategies for a VP Function of the Clinical Development, Medical & Regulatory Affairs (CMR) Business Unit.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... contracting agreements. In collaboration with the Associate Director, the Associate Manager will support CMR's partnership and alliance contract management strategy… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant ... and supports PV Operations' medical review function. This position supports a senior physician in evaluating and mitigating safety signals as they arise.… more
- Aequor (Newbury Park, CA)
- …- both oral and written. Ability to understand and communicate scientific/ clinical information, Organizational skills. Knowledge of clinical regulatory ... direction of a Global or US Regulatory Lead or Manager and will assist in the creation and submission...both oral and written Ability to understand and communicate scientific/ clinical information Ability to resolve conflicts and develop a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process ... As a result, this role will need to partner closely with teams and senior leaders from across Regulatory Affairs, as well as cross-functional stakeholders (eg, RA… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …organization and will work regularly with all business areas (Sales, Marketing, Clinical , TMPC, Med Affairs, and Regulatory Affairs) and support functions (IT, ... materials that pertain to training objectives for use at Senior Leadership meetings.Special Projects/Change ManagementAssist the Director in the implementation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …manage a lower complexity or regional project or be partnered with a more senior project manager in support of a larger, more complex drug development ... accountable for partnering with the Global Team and Global Clinical leader to ensure effective team operations through meeting...of more complex projects in collaboration with a more senior project manager . Establishes and maintains a… more
