Beckton Dickinson and Company: Jan 2017 till dateSenior Manager: Medical Affairs (Preanalytical systems): Jan 2019 onwards Work closely with south east asia team on creation and execution of clinical engagement plan Work as a primary contact to the Global Medical Affairs Leader for implementation of Medical Affairs strategyClinical Manager: Medical Affairs (Preanalytical systems): Jan 2017-Dec 2018 Collaborate with commercial and regulatory teams to provide essential scientific and medical marketing support to optimise business performance Develop and execute customer trainings and value add clinical engagement programmes KOL development and engagement at account level, professional bodies, instrument companies and government agencies. Build associate capabilities on product knowledge and commercial positioning Reviewing product complaints and generating medical opinions Plan, Develop and execute CME learning activities Represent the company in discussions with regulatory agencies on clinical matters relating to existing and future products Collaborates with marketing and regulatory teams to support product registration and marketing

Designation:  Associate director: Jan 2016-Jan2017 Senior Manager: CT/Compliance office: April 2013-Jan 2016 Site Manager for central laboratory CT Operations: Oct 2011-April 2013 Reported to: Global Director of Lab operations (based in US) Team size: 8 Job Responsibilities• Oversee all the Global and Local Clinical Trials specific processes within the Indian Laboratory, including study specific lab testing, Accessioning, Logistics and supply chain.• Provide to Global Clinical Trial colleagues (based out of US,UK, Australia, Singapore) detailed knowledge of local operational issues & Indian specific regulations & restrictions likely to affect the successful outcome of Clinical Trial’s participation in studies.• Ensuring staff are appropriately trained and processes are followed. • Conduct regular operations reviews to ensure compliance to existing processes, identify and solve problems, and implement process improvements.• Provide direct oversight for all Clinical Trials staff in India, ensures clear communication, expectations and deliverables. • Oversees the receipt, processing, accessioning and storage of all CT samples sent to the Indian Lab for testing in India, and/or referral to other testing locations, and/or long term sample storage and management.• Prepare weekly / monthly metrics and/or study status reports.• Provide support to the internal & external client for CT operations within India to improve local awareness of Quest Diagnostics Clinical Trials.• Key India contact for Sponsors and the local resource for problem solving and management of country specific client services.• Troubleshoot, resolve and manage service related issues.• Ensures study specific SOPs and/or work instructions are accurate and are in implemented prior to study start. • Work closely with BD team to ensure proper understanding of protocol and clear communications with the client right at the time of bidding.

Clinical trials-diagnostic lab Local and global trials management

Safety reportings to DCGI PSUR preparationArgus 4.2 SP1 HF1BSafety narrative writing for SAE's/AE's reported for ongoing and post-marketing drugs Finalization of narrative criteria Performing high level quality checking of narratives against the final SAE/Death listings Accurate transcription of medical details pertaining to the particular case/event Regulatory writing Clinical expert reports, non-clinical expert reportsSummary of product characteristicsInvestigator Brouchers

Selection of patients, conducting ICD, all study related procedures, IRB submissions, attended investigators meets

Job Description:Phase 3 study: Oral Antidiabetic agentsPhase II, III and IV studiesInhaled InsulinOral anticoagulants (in medical & surgical patients)Drugs For peripheral Neuropath

Job Description:Conducted and delivered lectures at state and national level CMEs and Workshops Delivered Lectures to M.B.B.S and Nursing students Hands on experience in drug testing in animal models and bio-statistics