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Nisha N Location
New York, NY, US
Nisha N Work
Director @ Pacific Biosafety Group (October 2018 - Present)
Medical writing consultant @ (November 2021 - Present)
Medical writing consultant @ (January 2019 - Present)
Nisha N Education
Manipal Academy of Higher Education 2012-2014
Nisha N Skills
Investigational New Drug Application (IND)
Abbreviated New Drug Application (ANDA)
Regulatory Compliance
Regulatory Requirements
Project Delivery
Pharmacovigilance
Clinical Research
Medical Writing
MedDRA
ICH-GCP
Clinical Trials
Drug Safety
GCP
Pharmaceutical Industry
FDA
Sop
Clinical Data Management
CRO
Regulatory Affairs
Oracle Clinical
CTMS
21 CFR Part 11
Team Leadership
EDC
Oncology
Clinical Development
Regulatory Submissions
Vaccines
Data Management
Clinical Monitoring
Team Building
Literature Reviews
aggregate reporting
Business Development
Manage Client Relationships
signal detection
Risk Management
CRM
Project Management
Standard Operating Procedure (SOP)
Good Clinical Practice (GCP)
U.S. Food and Drug Administration (FDA)
CRO Management
signal management
Capacity Planning
Contract Negotiation
Quality Assurance
People Management
Business Strategy
Outsourcing Management
Vendor Management
Medical Devices
Clinical evaluation report (CER)
Conflict Management
Cross-functional Team Leadership
Leadership
Leadership Development
Mediation
signal management
Nisha N Summary
Nisha N, based in New York, NY, US, is currently a Director at Pacific Biosafety Group. Nisha N brings experience from previous roles at Oxford Global Resources and BizMed. Nisha N holds a 2012 - 2014 Manipal Academy of Higher Education. With a robust skill set that includes Investigational New Drug Application (IND), Abbreviated New Drug Application (ANDA), Regulatory Compliance, Regulatory Requirements, Project Delivery and more. Nisha N has 1 emails and 1 mobile phone numbers on RocketReach.
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