- 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
- 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
- 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 (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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Interaction & Collaboration level: Requires interaction with vendors and key senior stakeholders at Sr manager and director level in ... other research areas centered around rare diseases and immune disorders. Summary: Manager , Sales Training and Development - Oncology serves as the training subject… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as well as other research areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is a member of the ... new reporting systems.Establish and implement programming standards and comply with regulatory requirements among project team members and across all studies.Review… 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
- 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
- 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 ... is responsible.Must understand and be updated with current Global Regulatory filing requirements and eCTD structure.Collaborate with Strategists (Leads), Publishers… more
- Axelon Services Corporation (Seattle, WA)
- Pay Ranges :$80 $89 Job Description: Technical Project Manager Location: Seattle WA Top Skills: - 5+ years' experience in bio tech/life sciences project management; ... drug development. - Familiarity with alliance management Job Description The Technical Project Manager (PM) will be a key member of the Cell Therapy Development… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- Senior Manager , Biostatistics This position reports to the local area Lead within Biostatistics and Data Management (BDM) group at SPARC. The main ... DB lock support topline results validation/interpretation, CSR co-authoring and eventual regulatory strategy development and submission. This is a hands-on position,… more
- Merck & Co. (Millsboro, DE)
- …documentation, and other information as needed for annual reports to Federal regulatory agencies. Leadership for internal and external regulatory inspections ... team of animal care and testing specialists.Serve as a member of the Senior Leadership Team for the Millsboro, DE biologics manufacturing site.Lead numerous projects… 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
- Sun Pharma (Taro Pharma) (Billerica, MA)
- …SOR/98-282), EU Medical Device Regulation 2017/745. Ensure site readiness for regulatory agency inspections and/or Sun Corporate Audits. Area Of Responsibilityas ... "Management Representative", leading all regulatory inspections related to medical device and combination products (FDA/ISO).Management Review meeting ensuring the… more
