Javed A. - Deputy Manager in Healtcare & Regulatory Afairs domain

Navi Mumbai, India

Experience

Nov 2019 - Jun 2024

4 years 8 months

Compose intricate clinical documents, such as clinical overviews (CTD), Clinical Study Reports (CSR), Protocol and HIPPA-compliant documents for different phases, and responses to Health Authority queries, ensuring punctual submission to global health authorities (ICH compliance).
Participates in program management activities. Identifies and resolves out-of-scope activities. Duties could include 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

Preparation of clinical study-related documents such as clinical study reports (CSRs), Clinical Protocols, Common Technical Documents, and various others as per regulatory requirements.
To adhere to the quality control of drafted documents, per the standard QC checklist.
Communication and coordination with clients to adhere to the required quality of deliverables.
Actively involved in key responsibilities of project management, resource allocation, quality assurance, and training the team members.

Nov 2016 - Sep 2017

11 months

Mumbai, India

Deliver medical writing proficiency in various project compounds within different therapeutic domain.
Performs authoring/quality check of Clinical Trial Registration and Results (CTRR-protocol registry forms and result summaries) documents 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 Report and Clinical Trial Transparency as per the regulatory guidelines (FDAAA 801 and Final Rule).

Mar 2015 - Oct 2016

1 year 8 months

Gurugram, India

Frame scientific content for clinical trial results to be posted on ClinicalTrials.gov and EudraCT based on information contained in the protocol, Clinical Study Report, Statistical Analysis Plan, and tables and listings.
Update clinical trial protocol based on amendments and results on ClinicalTrials.gov.
Responsible for Quality Control of draft Clinical Study Report based on standard QC checklist.
Participates in the development of medical writing-related Best Practices, SOPs, work instructions, style guides, and content guides to ensure efficient preparation of medical writing deliverables.

I have almost 10 years of experience in the medical regulatory affairs and medical writing domain, currently working as an Independent Consultant for Regulatory Affairs, Medical & Scientific Writing Key responsibilities are project management and regulatory document preparation and submission.
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.