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Naina Sharma

@nainasharma

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Experienced project manager specializing in regulatory medical writing.

India

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What I'm looking for

I am seeking a role that offers opportunities for leadership, team collaboration, and professional growth in regulatory medical writing.

I am a regulatory medical writing professional with over 9 years of experience in authoring and reviewing critical documents for global submissions, including CTD Modules 2 and 5. My career has been marked by a proven track record of leading cross-functional teams to prepare clinical study reports, protocols, informed consent forms, and regulatory summaries. I excel in structured content management and project planning, ensuring that all documentation adheres to stringent regulatory compliance and quality standards.

In my current role as a Project Manager at GSK, I oversee medical writing and clinical trial transparency deliverables, managing a team of five professionals. I have successfully handled high-priority vaccine assets, ensuring timely delivery of clinical and regulatory documentation aligned with global standards. My previous experience at Deloitte and Parexel has further honed my skills in managing multiple regulatory writing projects, mentoring teams, and enhancing document automation processes, which have significantly improved efficiency and consistency across deliverables.

With a strong focus on quality and adherence to submission timelines, I am committed to driving project success and fostering a collaborative environment. I am passionate about mentoring junior staff and contributing to the development of standardized content libraries that support business growth and regulatory compliance.

Experience

Work history, roles, and key accomplishments

Project Manager – Medical Writing & Clinical Trial Transparency

GSK

Jan 2023 - Jun 2025 (2 years 5 months)

Project manager for medical writing and transparency deliverables including clinical study reports and protocols. Managed a team of 5 professionals, overseeing project deliverables, timelines, and performance reviews.

Clinical Study Project Management Regulatory Compliance MS Word Jira

Consultant and Senior Consultant, Medical Writing

Deloitte USI Consulting

Apr 2020 - Dec 2022 (2 years 8 months)

Managed multiple regulatory writing projects and led a team of writers for CSR, CTD summaries, and labels. Led the automation of 20+ regulatory medical writing documents using InteliNotion, enhancing consistency and efficiency.

Regulatory Writing CTD CSR InteliNotion Project Management Team Leadership

Medical Writer I

Parexel International

Jul 2017 - Apr 2020 (2 years 9 months)

Prepared and peer-reviewed over 20+ regulatory documents, including CSRs, safety narratives, ICFs, and disclosure documents. Coordinated with clinical, data management, and biostatistics teams to streamline content development.

Regulatory Safety Narratives Clinical Data Management Biostatistics

Medical Writer

Tech Observer India Pvt. Ltd

Aug 2016 - Jun 2017 (10 months)

Supported 10+ CSRs, manuscripts, abstracts, and posters in collaboration with international teams. Ensured regulatory compliance and liaised with sponsors throughout the project lifecycle.

Manuscripts Abstract Regulatory Compliance Medical Writing

Junior Medical Writer

Tech Observer India Pvt. Ltd

Dec 2014 - Aug 2016 (1 year 8 months)

Supported the development of 5+ CSRs and manuscripts and contributed to CRF authoring and QC. Ensured regulatory compliance and liaised with sponsors throughout the project lifecycle.

Manuscripts Quality Control Regulatory Compliance Medical Writing

Education

Degrees, certifications, and relevant coursework

IIM Ahmedabad

General Management Program, General Management

Grade: 9.00

Completed a General Management Program at IIM Ahmedabad, focusing on advanced management principles. Achieved a GPA of 9.00, demonstrating strong academic performance in business and leadership studies.

BIT Ranchi

M.S. in Clinical Research and Pharmacovigilance, Clinical Research and Pharmacovigilance

Grade: 9.00

Obtained a Master of Science degree in Clinical Research and Pharmacovigilance from BIT Ranchi. Maintained a GPA of 9.00, indicating a comprehensive understanding of clinical research methodologies and drug safety.

Amity University, Noida

B.Tech in Biotechnology, Biotechnology

Grade: 7.05

Earned a Bachelor of Technology degree in Biotechnology from Amity University, Noida. Achieved a GPA of 7.05, covering fundamental and advanced topics in biotechnology.