Freelance Consultant For Clinical Development And Regulatory Medical Writing
Self-Employed
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Darshan Dave Email & Phone Number
Freelance Consultant for Clinical Development and Regulatory Medical Writing
at
Self-employed
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Current company
Role
Freelance Consultant for Clinical Development and Regulatory Medical Writing
Location
Greater Ahmedabad Area, India
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Darshan Dave is listed as Freelance Consultant for Clinical Development and Regulatory Medical Writing at Self-employed, based in Greater Ahmedabad Area, India. AeroLeads shows a matched LinkedIn profile for Darshan Dave.
Darshan Dave previously worked as Clinical Development Consultant & Regulatory Medical Writer at Basilion and Senior Medical Writer at Biorasi. Darshan Dave holds Master'S Degree, Masters In Pharmacy, Specialised In Pharmacology from Gujarat Technological University (Gtu).
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Self-employed
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About Darshan Dave
A Certified Pharmacist & Clinical Research Professional having 14+ years of hands-on industry experience and possess following skills which helps life science innovators to grow faster.1. Technical skills- Clinical Development, Clinical Study Outsourcing, Regulatory Medical Writing, Project Management, GCP Monitoring & Auditing, Quality & Regulatory Compliance.2. Leadership skills- Resource (Skilled Professional, Budget, Timelines & Quality) Management, Critical Thinking, Conflict Resolution, Problem Solving, Effective Communication, Being Proactive, strategic approach, etc.3. Business Skills- RFx Preparation, Prospect presentations, Budgeting, Negotiations, Bid Defense, Contracting, Project Health Update, Client Management, Risk Analysis, etc.
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10 roles
Darshan Dave work experience
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Clinical Development Consultant & Regulatory Medical Writer
CurrentCurrently, I am working as “Independent Consultant” and heling life science innovators globally into their product development journey i.e. IND, NDA, BLA, ANDA & 505(B2) submissions through following consulting services.1. Clinical Development - Clinical Study Design, Regulatory & Feasibility Assessment, CRO Outsourcing- Qualification, Negotiations, Contracting and End to End Project Management (timeline, resource & quality). 2. Regulatory Medical Writing – a. Clinical Study Documents - Clinical Study Protocol (CSP), Investigator Brochure (IB), Informed Consent Form (ICF), Case Report Form (CRF), Clinical Study Report (CSR), Patient Narratives) etc. b. Aggregate Report Writing - Periodic Safety Updated Report (PSUR), Periodic Benefit-Risk Evaluation Report (PBRER), Development Safety Updated Report (DSUR), Risk Management Plan (RMP) etc.c. Marketing Authorization Application (MAA) - eCTD (Module 2.4 to 2.7 preparation), Summary of Product Characteristics (SmPC), Product Information Leaflets (PIL), Product Monograph (PI) etc.d. Regulatory Affairs- Briefing Books, Regulatory Advice, Scientific Advise, Query Responses. 3. Clinical Study Monitoring & Auditing - GCP Monitoring & Auditing- Onsite/Remote (100% SDV).4. Independent Audit of CRO/ Clinical Trial Sites/ Vendor - Quality Management System (QMS) audit according to global regulatory standards.
Feb 2019 - Present
Senior Medical Writer
Sep 2022 - Apr 2024
Associate Scientist - Biopharmaceutics & Project Management
Jul 2016 - Feb 2019
Senior Scientific Assistant- Clinical Research
Jun 2012 - Jul 2016
Clinical Research Coordinator
Shah Multi Specialty Hospital
Aug 2011 - Jun 2012
Research Trainee
Sep 2010 - Jul 2011
Production Trainee
Jun 2009 - Aug 2009
Pharmacy Manager
Naman Medical Store
Aug 2005 - Apr 2009
Hospital Pharmacist
May 2005 - Aug 2005
1 education record
Darshan Dave education
FAQ
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What company does Darshan Dave work for?
Darshan Dave works for Self-employed.
What is Darshan Dave's role at Self-employed?
Darshan Dave is listed as Freelance Consultant for Clinical Development and Regulatory Medical Writing at Self-employed.
Where is Darshan Dave based?
Darshan Dave is based in Greater Ahmedabad Area, India while working with Self-employed.
What companies has Darshan Dave worked for?
Darshan Dave has worked for Self-Employed, Basilion, Biorasi, Veeda Clinical Research Limited, and Zydus Research Centre.
How can I contact Darshan Dave?
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What schools did Darshan Dave attend?
Darshan Dave holds Master'S Degree, Masters In Pharmacy, Specialised In Pharmacology from Gujarat Technological University (Gtu).
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