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Shital Desai

@shitaldesai

Senior medical writer with 10+ years in regulatory writing and scientific communication, delivering compliant documents under tight timelines.

India

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What I'm looking for

I’m looking for a Senior Medical Writer role where I can author compliant protocols/ICFs and regulatory submissions, collaborate closely with cross-functional stakeholders, own timely deliverables, and continue improving workflows with tools and GenAI.

I’m an experienced medical writer with 10+ years focused on regulatory writing and scientific communication. I author high-quality, compliant documents using strong knowledge of ICH-GCP guidelines and deliver under tight timelines.

In my current roles, I’ve led protocol and ICF development end-to-end—covering concept protocols, full protocols, amendments, and addendum/revisions. I also support document redaction based on CCI lists, build timelines, and facilitate consolidation meetings with internal and external stakeholders.

I author and review core regulatory and scientific deliverables including CSRs, safety narratives, and CTD Module 2 content. I’ve also prepared literature summaries for IND and NDA submissions using the 505(b)(2) regulatory pathway, including literature search and screening against specified inclusion/exclusion criteria.

I combine deep documentation expertise with practical tooling and continuous improvement. I work with systems like Veeva, PleaseReview, EndNote, PerfectIt, and Onstyle, and I’ve completed GenAI training to integrate AI tools into my daily workflow.

Experience

Work history, roles, and key accomplishments

Current

Senior Associate Medical Writer

Current

Indegene

Feb 2024 - Present (2 years 4 months)

Authored concept protocols, full protocols, and ICFs; produced protocol amendments and ICF addendum/revisions with redactions based on the CCI list. Led consolidation meetings, collaborated with cross-functional stakeholders, and managed document timelines for client deliverables.

Protocol Authoring Protocol Amendments Redactions Stakeholder Management

Senior Medical Writer

Alvotech Biosciences India Pvt. Ltd.

Aug 2022 - Jan 2024 (1 year 5 months)

Authored CSPs and CSRs and contributed scientific communication materials (manuscripts, conference abstracts, and slide decks) in collaboration with medical affairs. Authored and reviewed program-level documents including CDPs and IBs.

Safety Narratives CDP IB Document Authoring Scientific Communications

Scientific and Medical Writer

Springer Nature

Feb 2021 - Aug 2022 (1 year 6 months)

Created and maintained drug profiles from drug inception through market launch, including patent filing/expiry and labeling updates. Conducted data mining and literature reviews from company pipelines and public sources to support investor presentations, media releases, and other regulatory/clinical content.

Patent & Labeling Updates Data Mining literature review Investor Media Research

Freelance Medical Writer

Aug 2018 - Feb 2021 (2 years 6 months)

Authored manuscripts, review articles, meta-analyses, CSRs/CSPs, and case reports, and supported patient/doctor information documents and academic assignments. Provided evaluation and rewriting services to client requirements and ensured timely, high-quality delivery with support through publication.

Review Article Writing CSR CSP Authoring Medical Rewriting Thesis Support Publication Support Quality Assurance

Junior Scientific & Medical Writer

Springer Nature

Dec 2013 - Aug 2018 (4 years 8 months)

Performed quality checks of trial profiles and ensured accurate processing of regulatory information. Resolved editor queries, handled CAPA filing, maintained QC records, and supported SOP/guideline creation and updates.

Trial Profile QC Query Resolution CAPA SOP Development Quality & Compliance