2014 -2015 Assistant Manager- Pharmacovigilance and Medical Writing and Clinical Operations @
2008 -2014 Team Lead - PV and Medical writing @
Reena Malik Education
Maharashtra University of Health Sciences
BAMS (Medicine) (Medicine)
Northeastern University
Master's degree (Project Management with Regulatory Affairs Concenteration)
Reena Malik Skills
Microsoft Office
Pharmacovigilance
Clinical Trials
Clinical Data Management
ICH-GCP
GCP
Regulatory Affairs
Pharmaceutical Industry
Good Clinical Practice (GCP)
Clinical Research
FDA
Quality Assurance
SOP
Medical Writing
Project Management
Regulatory Requirements
Standard Operating Procedure (SOP)
Life Sciences
21 CFR Part 11
Regulatory Submissions
Healthcare
U.S. Food and Drug Administration (FDA)
Data Analysis
Data Management
Clinical Development
Oncology
U.S. Title 21 CFR Part 11 Regulation
Business Process Improvement
Pharmacy
Microsoft Word
Microsoft Project
Microsoft Outlook
Team Management
Management
Training
CRO
CRO Management
Process Improvement
Protocol
Ind
Microsoft PowerPoint
Decision-Making
PowerPoint
Ich Gcp
GMP
Good Clinical Practice Gcp
Microsoft Excel
U.S. Food And Drug Administration Fda
Standard Operating Procedure Sop
Writing
RCA
Consulting
Market
Psychiatry
Surgery
CDS
Vendors
EDX
Data Entry
Narrative
Train the Trainer
Performer
Finance
Digital Preservation
Cascade
NDA
SEP IRA
PMA
Literature
SME
Wow
Disease
Systematic
Search
HTTPS
Briefing
Computer Science
Science
Tpp
Key Performance Indicators
Therapeutic Areas
Scenario
CRM
Technology Solutions
Auditing
21 CFR
Boston
Source
SharePoint
Respiration
Workflow
Cardiovascular
Literature Reviews
System
Mental Health
Training Material
Sage Act
Reports
Template
Rare
Medicine
PV
Live Link
COBOL
Supervisory
Panchakarma
Ayurveda
Mind
Conferences
Subject Matter Expert
Informatics
Quality Control
Trains and Add Rails
Argus Safety
Reporting
Shares
EMA
CAPA
Surveillance
Analysis
Urology
Consultancy Services
Reference Manager
Comments
Management System
Renal
eCTD
Query Writing
Conventions
HIPAA
FMEA
Dossiers
TGA
MedDRA
Novartis
Safety
Medical History
Workshops
Triage
Argus
Cts
Marketing
New Hires
Spl
Timelines
Medical Review
Orphan Drugs
IDE
Automobile
Drug Safety
Dashboard
Liver
Etiquette
LinkedIn
Six Sigma
Yellow Belt
Regulations
Labelling
Rems
Distribution
International
Rmp
TMF
Small Molecules
Client Meetings
Microsoft Exchange
IRB
Reviews
Electronics
Transplant
Pregnancy
Academic
Disclosure
ICH guidelines
Guidelines
Bridge Inspection
Property Management Systems
Medical Devices
Concerts
Annual Reports
India
Certified Trainer
Patient Care
Conducting Interviews
Biologics
Unlimited
EndNote
Appraisals
Yoga
Inclusion
Psur
Meetings
EMEA
Neurovascular
Databases
Standard Operating Procedure
u.s. Food and Drug Administration
Good Clinical Practice
Reena Malik Summary
Reena Malik, based in Boston, MA, US, is currently a Associate Director Regulatory Affairs at Alkermes. Reena Malik brings experience from previous roles at Q32 Bio Inc., ICON plc and PRA Health Science. Reena Malik holds a BAMS (Medicine) in Medicine @ Maharashtra University of Health Sciences. With a robust skill set that includes Microsoft Office, Pharmacovigilance, Clinical Trials, Clinical Data Management, ICH-GCP and more. Reena Malik has 2 emails and 3 mobile phone numbers on RocketReach.
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