Shraddha Shruti Tripathy

Senior Manager at Parexel

Role: Senior Manager at Parexel
Location: Mumbai, MH, IN
LinkedIn followers: 500 followers

Manufacturing & ProductionView LinkedIn profile

About Shraddha Shruti Tripathy

Have an overall experience of 13+ years; with below expertise - Team Management- Training and supervising staff- Performing electronic publishing tasks including creation of TOC, compile, publish and validate submission using eCTD software. Format and manage submission templates to assure the standards outlined by the Sponsor\'s style guide are met- Providing Electronic Document Publishing support for Global submissions like MAA (Marketing Authorization Application), License renewal, Annual Report, Labelling updates, CMC & Clinical Variations- Submission activity including assembly creation, document verification, rendering, bookmarking/ linking, compilation (as per Module 1-5 in CTD format), publishing; and validation of submission as per country specific eCTD or NeeS (where applicable) requirements.

Experience

Senior Manager
Parexel
Apr 2022 — Present

Skills

Standard Operating Procedure (Sop)
Team Management
Ich-Gcp
CRO
Clinical Trials
Clinical Research
Regulatory Affairs
Medical Writing
Regulatory Submissions
Regulatory Documentation
Pharmacovigilance
Gmp
Team Leadership

Contact information

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Work email
•••••@parexel.com
Personal email
•••••@•••••.com
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Current company

Parexel

Pharmaceutical Manufacturing · 22K employees · Raleigh, North Carolina, United States

Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our 22,000+ global employees work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™ We continue to earn recognition industrywide, including the 2025 Scrip Award for “Best Contract Research Organization – Full-Service Provider,” 2024 Fierce Biotech CRO Award for "Innovative Approaches to Patient-Centric Research" and the 2024 and 2023 Society for Clinical Research Sites Eagle Award. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.

parexel.com

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