- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence ... archive. Bring issues with the reconciliation to the attention of the Study Manager and propose remediation plan.Distribute key study documents to the CRO and… more
- Aequor (Seattle, WA)
- Job Description: Position: Technical Project Manager Location: Seattle WA Top Skills: 5&plus years' experience in bio tech/life sciences project management; cell ... CMC drug development. Familiarity with alliance management Job Description The Technical Project Manager (PM) will be a key member of the Cell Therapy Development… more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you. Job Summary The Senior Manager , Alzheimer's Disease - Site of Care Marketing will assist with the ... project teams involving Marketing, Sales, Managed Markets/Market Access, Legal, Regulatory , Medical, PR, agencies, actively soliciting team expertise and input… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global ... this role will need to partner closely with teams and senior leaders from across Regulatory Affairs, as well as cross-functional stakeholders (eg, RA CMC, R&D… more
- Eisai, Inc (Nutley, NJ)
- …in alignment with IT security strategy. Prepares security reports to regulatory agencies. Audits and manages access management. Job Responsibilities: Architect and ... scalable security architecture that aligns with industry best practices, regulatory requirements, and organizational goals. Develop, implement, and enforce… 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
- 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
- Aequor (Thousand Oaks, CA)
- …group. Ability to evaluate documentation/ operations according to company and regulatory guidelines Ability to interact with regulatory agencies. Demonstrate ... SAP Projects Must have Looking for candidates with 10&plus years of experience. Travel required about 1 week a month - multiple short trips. In support of 's Quality Assurance program manages and oversees the operations of a specific area(s) of responsibility… more
- Merck & Co. (Durham, NC)
- Job Description GENERAL SUMMARY :The Sr . Tech, Engineering is a member of the Engineering team providing technical support to the manufacturing site. The site ... guided by policies, procedures and business plan; receives guidance from manager .Contributes to the performance and results of the department.Identifies and resolves… more
- Merck & Co. (Rahway, NJ)
- …tactical input from diverse disciplines (eg, biology, chemistry, pharmacology, clinical, regulatory , access, supply, and other areas), as applicable to the project. ... unmatched opportunity to build your career as a project manager in a highly complex and important field. You...Transition Opportunities: This Fellowship will be geared towards a Sr Specialist position and aligns to a full time… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …requirements.Responsibilities Interaction & Collaboration level: Requires interaction with vendors and key senior stakeholders at Sr manager and director ... other research areas centered around rare diseases and immune disorders. Summary: Manager , Sales Training and Development - Oncology serves as the training subject… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …analyses execution, quality control, and data derivation; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical ... statistical methodologies.- Some understanding of current drug development trends and regulatory environments.- Sufficient programming skills in SAS and/or R and… more
- Aequor (Thousand Oaks, CA)
- …resumes attached of a ideal candidate for this role NOTES FROM HIRING MANAGER : Looking for hands on *STRONG* engineer experience with proper training/ background in ... associated with cGMP equipment and facilities at Thousand Oaks (ATO). The senior engineer works in partnership with the automation, maintenance, project management,… more
- Novo Nordisk Inc. (Chicago, IL)
- …pricing implications and downstream impact of the evolving public policy, government, regulatory landscape and other relevant trends Identifies and builds a broad ... implications and downstream impact of the evolving public policy, government, regulatory landscape and other relevant trends Continuously identifies and prioritizes… 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 ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …functions, as well as building a network with key staff members including senior management, the global functional leads, Regulatory Intelligence, and Policy and ... around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities to comply with US, EU, Japan… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- …quality checking, and reporting.Communicates effectively with internal team members, senior management, external experts and regulatory authoritiesAuthoring or ... of Clinical Data ManagementJob Grade:G6/G7Department:Biostatistics and Data ManagementFLSA Classification: Manager 's Job Title:Head of BDMDepartment Head Title:Associate VPDoes This… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …business areas (Sales, Marketing, Clinical, TMPC, Med Affairs, and Regulatory Affairs) and support functions (IT, Finance, HR, and Legal).ResponsibilitiesTraining ... materials that pertain to training objectives for use at Senior Leadership meetings.Special Projects/Change ManagementAssist the Director in the implementation… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- …way we work every day is important to us.DOWNLOAD OUR CODE OF CONDUCT The Senior Manager , Regulatory Affairs will handle publishing and coordinating tasks ... and society at large. Through active fieldwork, dedicated research teams, and in recognition of the efforts who work behind the scenes to combat illness and… 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 ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
