Javed Alam

Regulatory Affairs, Medical & Scientific Writing Consultant

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Navi Mumbai, India

Experience

Jul 2024 - Present
1 year 7 months

Regulatory Affairs, Medical & Scientific Writing Consultant

Independent Consultant

  • Experience in drafting & management of various clinical documents for regulatory filings, particularly CTD Module 2.5 (Clinical Overview) and Module 2.7 (Clinical Summaries). Key documents include Clinical Study Reports (CSRs), amendments to Clinical Study Protocols, Informed Consent Forms (ICFs), and Investigators' Brochures
  • Lead cross-functional teams to draft agreed-upon scientific/medical content that addresses data interpretation, product claims, and internal/external leads
  • Strong understanding of the clinical development process, including program planning, submission, and clinical trials. Knowledgeable in FDA and ICH regulations and industry standards for data capture and management
  • Skilled in task management, coordinating work plans, and prioritizing tasks based on submission timelines. Knowledgeable in data management best practices and technologies for clinical trials
  • Engages with external professional initiatives and organizations, including SCDM, CDISC, and DIA, to collaboratively identify industry best practices and thoughtfully enhance the visibility of clients
Nov 2019 - Jun 2024
4 years 8 months

Deputy Manager, Healthcare & Regulatory Affairs

Citiustech Healthcare

  • Compose intricate clinical documents, such as clinical overviews (CTD), Clinical Study Reports (CSR), Protocol and HIPAA-compliant documents for different phases, and responses to Health Authority queries, ensuring punctual submission to global health authorities (ICH compliance)
  • Participate in program management activities, identifying and resolving out-of-scope activities, including developing timelines, budgets, forecasts, and contract modifications
  • Participate in project strategy sessions, focusing on messaging and document flow; create engaging data review listings and visualization specifications, present them to the team, seek feedback, and incorporate necessary changes
Dec 2017 - Nov 2019
2 years
Mumbai, India

Senior Medical Writer

Cognizant

  • Preparation of clinical study-related documents such as clinical study reports (CSRs), clinical protocols, Common Technical Documents, and various others as per regulatory requirements
  • Adhere to the quality control of drafted documents per the standard QC checklist
  • Communicate and coordinate with clients to adhere to the required quality of deliverables
  • Actively involved in project management, resource allocation, quality assurance, and training team members
Nov 2016 - Sep 2017
11 months
Mumbai, India

Medical Writer

Siro Clinpharm

  • Deliver medical writing proficiency in various project compounds within different therapeutic domains
  • Perform authoring/quality check of Clinical Trial Registration and Results (CTRR–protocol registry forms and result summaries) to ensure quality deliverables by using PharmaCM
  • Point of contact for disclosure projects; responsible for drafting and quality control of clinical and safety documents such as Clinical Study Reports and clinical trial transparency as per regulatory guidelines (FDAAA 801 and Final Rule)
Mar 2015 - Oct 2016
1 year 8 months
Gurugram, India

Associate Medical Writer

Kinapse

  • Frame scientific content for clinical trial results to be posted on ClinicalTrials.gov and EudraCT based on protocol, Clinical Study Report, Statistical Analysis Plan, and tables and listings
  • Update clinical trial protocol based on amendments and results on ClinicalTrials.gov
  • Quality control of draft Clinical Study Reports based on standard QC checklist
  • Participate in developing best practices, SOPs, work instructions, style guides, and content guides to ensure efficient preparation of medical writing deliverables

Summary

To seek a good position in an organization where I can enhance my abilities and gain extensive knowledge to achieve the organization's goal.

Languages

English
Advanced

Education

Poona College of Pharmacy, Bharati Vidyapeeth

Master of Pharmacy, Pharmacology · Pharmacy · Pune, India

Certifications & licenses

International Fellowship On Healthcare Technology

WHO at Kalam Institute of Health Technology

National Workshop On Health Data Analytics

AIIMS Kalyani

Basic And Advanced Healthcare Technology Assessment 2022

Post Graduate Institute Of Medical Education And Research, Chandigarh

Data Analysis Using R (RIntro 2022)

Sree Chitra Tirunal Institute For Medical Sciences And Technology, Trivandrum Medical College

Introduction To The Principles And Practice Of Clinical Research

National Institute Of Health

Principles Of Clinical Pharmacology

National Institute Of Health

Health Technology Assessment

University Of Sheffield

Introduction To Systematic Review And Meta-Analysis

Johns Hopkins University

Understanding Clinical Research: Behind The Statistics

University Of Cape Town

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