Tanushree N
Associate - Clinical eSubmission and Technical Compliance
Bangalore
Summary
Dedicated life science professional with history of meeting company goals utilizing consistent and organized practices. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brand.
Overview
10
10
years of professional experience
5
5
years of post-secondary education
3
3
Certifications
Work History
Associate - Clinical ESubmission and Technical Com
GSK
07.2022 - Current
- Experienced in working on various clinical and regulatory document types including ICF, SAP, Protocol, IB, CSR and Module 2.
- Proficient in using Veeva, Onstyle and ISI Toolbox.
- SME for Protocol process and compliance check.
- Streamlined protocol process to increase efficiency in document QC and finalization
- Participated in meetings and conference calls to gather and communicate document layout and production process information and represent production function.
- Mentored junior staff members to foster professional growth and skill development within the team.
- Streamlined submission processes for increased efficiency and time management.
- Assisted in the development of internal guidelines and procedures for submission processes, enhancing overall effectiveness.
- Established strong working relationships with key contacts at regulatory agencies to facilitate smooth submission processes.
- Managed stakeholder expectations through clear communication regarding timelines, deliverables, and project statuses related to document submissions.
Senior Scientific Analyst (Consultant)
Molecular Connections Pvt Ltd
09.2021 - 06.2022
- Review assigned scientific literature from various peer reviewed journal and databases
- Extract data as per defined SOP for Literature Data review and extraction
- Encode extracted data in predefined databases (internal company/client owned databases)
- Mentor newcomers on SOP, working instructions, guidelines, ways of working etc.,
- Meet monthly targets and review targets with manager to define plan of action to meet annual targets.
- Proved successful working within tight deadlines and fast-paced atmosphere.
- Developed and implemented performance improvement strategies and plans to promote continuous improvement.
- Used coordination and planning skills to achieve results according to schedule.
Sabaticle- Maternity Break
NA
06.2020 - 08.2021
Senior Scientific Analyst
Molecular Connections Pvt Ltd
06.2015 - 05.2020
- Performed research into study topics to increase knowledge and to provide valuable contributions.
- Streamlined research processes to meet tight deadlines for multiple projects.
- Review assigned scientific literature from various peer reviewed journal and databases
- Extract data as per defined SOP for Literature Data review and extraction
- Encode the extracted data in predefined databases (internal company/client owned databases)
- Mentor newcomers on SOP, working instructions, guidelines, ways of working etc.,
- Meet monthly targets and review targets with manager to define plan of action to meet annual targets.
Junior Research Fellow
St Joseph's Autonomous College
06.2014 - 05.2015
- Followed best practices and scientific protocol to reach defensible conclusions based on solid evidence.
- Maintained high levels of confidentiality to protect data quality and project research.
- Collaborated with other researchers to write and distribute impactful results of microbiology research.
- Recorded data from research to allow for accurate analysis.
Education
Master of Science - Biochemistry
Jain University
06.2012 - 06.2014
Bachelor of Science - Biochemistry
Vijaya College, Bangalore University
06.2009 - 06.2012
Skills
Scientific paper experience
Scientific methodologies
Analytical/Scientific Software
Scientific Method
Attention to Detail
Cultural Awareness
Adaptability and innovation
Team Management
Languages
English, Kannada, Hindi & Telugu
Additional Information
- GENDER : Female
- MARITAL STATUS: Married
Certification
Quality Risk Management in Clinical Trials (Udemy)
Timeline
Associate - Clinical ESubmission and Technical Com
GSK
07.2022 - Current
Quality Risk Management in Clinical Trials (Udemy)
05-2022
Systematic Litertature Search and Review [PRISMA Guidelines] (Udemy)
05-2022
Fully Accredited Professional Child Psycology Diploma (Udemy)
05-2022
Senior Scientific Analyst (Consultant)
Molecular Connections Pvt Ltd
09.2021 - 06.2022
Sabaticle- Maternity Break
NA
06.2020 - 08.2021
Senior Scientific Analyst
Molecular Connections Pvt Ltd
06.2015 - 05.2020
Junior Research Fellow
St Joseph's Autonomous College
06.2014 - 05.2015
Master of Science - Biochemistry
Jain University
06.2012 - 06.2014
Bachelor of Science - Biochemistry
Vijaya College, Bangalore University
06.2009 - 06.2012
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