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5.0

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Sailaja Mundandhara

I have known Sneha for the past four years now. I have seen her develop as a thorough professional within the team and her passion for medical writing. She is smart, well-organized, detail-oriented in her work and with great communication skills. Sneha has good work ethics and is a very good team player. She understands the business needs, plans and executes it perfectly to meet the expectations. Sneha will be an asset to any organization she joins and I wish her good luck.

Sunita Cheruku

I have known Sneha for about four years now, both as a colleague and a friend. It was a pleasure watching her develop into a valuable submission writer within the team. One aspect that strikes you while working with Sneha is her never-ending passion to learn and grow. She is a thorough professional, and is extremely dedicated to her work. She understands the rigours of the business and is extremely conscious of meeting timelines and with good quality. She is a very friendly person and gets along well with all. I am sure that Sneha would be an asset to any organization that she joins. I wish her good luck in all her future endeavors.

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Experience

    • Australia
    • Advertising Services
    • 1 - 100 Employee
    • Principal Medical Writer
      • Apr 2021 - Present

    • Senior Medical Writer
      • Sep 2017 - Apr 2021

    • Medical Writer
      • Jun 2015 - Aug 2017

      - Responsible for producing scientifically sound promotional and educational content across various media in print and digital- Experience across several therapeutic areas, with a primary focus on oncology and haematological malignancies- Cross-functional collaboration with creative and digital teams- Thorough understanding of client's brands and their marketing strategies and contribution towards strategic solutions and creative ideas

    • Switzerland
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Submission Writer-I / Medical Writer-II
      • Apr 2012 - May 2014

      Objective of the role:-To write, review and/or manage the production of high quality clinical and safety documentation for submission to regulatory authorities in support of marketing applications.-To manage the production of other documentation via outsourcing.-To coach/mentor less experienced submission writers.Major activities:-To author, review and independently manage high quality clinical and safety documents such as non-registration CSRs, DSURs, CTRDs.-To lead outsourced narrative projects and coordinate outsourced activities-Core member of Clinical Trial Teams (CTTs), documentation consultant in CTTs to ensure compliance as per company standards and regulatory guidelines.-Actively participate in planning of data analyses and presentation to be used in CSRs Show less

    • Medical Writer-I
      • May 2010 - Mar 2012

      Joined the Oncology Submission Management (OSM) team in Hyderabad, India, part of the global OSM group spread across 5 sites - Basel (Switzerland), East Hanover (USA), Hyderabad (India), Beijing (China), Tokyo (Japan).Objective of the role: To write, edit and reconcile high quality medical and scientific communications for submission to regulatory authorities and/or clinical teams.Major activities:- Production of high quality clinical documentation: Narratives and CTRDs (writing & reviewing)- Support the development of OSM-Hyderabad through participating in OSM initiatives and other related activities- Fostering cross functional communication to optimize feed-back and input towards high quality documents Show less

    • India
    • IT Services and IT Consulting
    • 700 & Above Employee
    • Document Compilation Specialist
      • Oct 2008 - May 2010

      Worked with TATA Consultancy Services (TCS) on GlaxoSmithkline projects as part of the TCS-GSK Global Development Centre. Major activities: - To work with the US Regulatory Executive and Project Physician Leaders and compile components of modules for IND/NDA Annual Reports for submission to the US FDA. - To conduct literature review using internal databases and prepare NDA Annual Report bibliographies. Worked with TATA Consultancy Services (TCS) on GlaxoSmithkline projects as part of the TCS-GSK Global Development Centre. Major activities: - To work with the US Regulatory Executive and Project Physician Leaders and compile components of modules for IND/NDA Annual Reports for submission to the US FDA. - To conduct literature review using internal databases and prepare NDA Annual Report bibliographies.

Education

  • Cranfield University
    MSc, Clinical Research
    2006 - 2008

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