Nischith Radhakrishna
Senior Project Manager at Parexel | Global Project Leadership | Regulatory Consulting
- Role
- Senior Project Manager at Parexel
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Nischith Radhakrishna
Extensive experience in eCTD Publishing and Post Publishing QC for diverse regulatory submissions (IND, NDA, EU, Swiss, etc.).Skilled in handling a wide range of submissions, including IND, NDA, DSUR, Annual Reports, and Amendments.Demonstrated ability to create Lifecycle Submissions based on client-provided planners.Conducted publishing activities such as sequence building, document assignment, eCTD publishing, and dispatch via Electronic Submission Gateways.Subject Matter Expert in technical editing and formatting of Word and PDF documents to meet industry and client-specific requirements.Proven track record in project management, including tracking deliverables, delegating tasks, ensuring quality control, and standardizing project-related tasks.Proficient in document management processes, including authoring, revisions, SOP creation, file transfers, tracking, and archival.Developed project-specific training materials and job aides, optimizing workflows for enhanced efficiency.Led departmental training sessions on eCTD Publishing, Submission Management, Insight Publisher, SmartDesk, Adobe Acrobat, and MS Word.Technical Expertise:Publishing: InSight Publisher, Lorenz docuBridge, Extedo\'s eCTDManager.Adobe Acrobat, Liquent SmartDesk (PDF/Authoring), ISI Toolbox, ISI Writer, MS Office Suite, MS Visio, Power BI.Document Management Systems: SharePoint, Veeva Vault, FirstDoc, D2, PMED, WorkZone.Technical Validators: Insight Validator, Lorenz eValidator, EURSvalidator, Global Validator.
Experience
Senior Project Manager
Oct 2024 — Present · Bengaluru, IN
Education
St. John's English School
School
1998 — 2008
Presidency University Bangalore
Pre-university, Physics, Chemistry, Mathematics and Biology
2008 — 2010
Bangalore University
M.Sc. - Master of Science (studied at MS Ramaiah College of Arts, Science and Commerce), Microbiology
2013 — 2015
Bangalore University
B.Sc. - Bachelor of Science (studied at Presidency College, Bangalore), Biotechnology, Chemistry & Microbiology
2010 — 2013
Skills
- Microsoft Office
- Gel Electrophoresis
- Citrix Xendesktop
- Soft Skills
- Microsoft Excel
- Linkedin Recruiter
- Customer Service
- Careerbuilder
- U.s. Food and Drug Administration (Fda)
- Pearl
- Microbiology
- Management
- Job Diva
- Electronic Common Technical Document (Ectd)
- Logo Design
- Team Management
- Regulatory Operations
- Monster
- Citrix Xenapp
- Desktop Computers
- Software Troubleshooting
- Molecular Biology
- Insight Publisher
- Staffing
- Biotechnology
- Dna
- Europe, the Middle East, and Africa (Emea)
- Digital Photography
- Ema
- Human Resources
- Computer Hardware Installation
- Clinical Recruitment
- Recruiting
- Life Sciences
- Sds-Page
- Sourcing
- Biochemistry
- Graphic Design
- Document Preparation
- Microsoft Word
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.