Bharesh K. Chauhan

Experience

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  Columbia University Vagelos College of Physicians and Surgeons

  Jan 1991 - Jan 1992

  Research Assistant (Mentor: Prof. Anthony Ratcliffe)

  1 year sabbatical - assisted in characterizing the human aggrecan gene that is required for articular cartilage development.

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  Kennedy Institute of Rheumatology

  Jan 1993 - Jan 1993

  Research Assistant (Mentor: Prof. Jayesh Dudhia)

  Summer job before going onto my graduate studies at Oxford University - analyzed articular cartilage protein content by Western blotting.

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  British Biotech, plc

  Sept 1993 - Aug 1995

  Staff Junior Scientist (Mentor: Dr. Tim French)

  1. Collaborated with scientists at the company to generate efficient baculovirus vectors. 2. Gained experience working in a biotechnology company.

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  Nuffield Laboratory of Ophthalmology, John Radcliffe Hospital

  Jan 1998 - Jan 1998

  Research Assistant (Mentor: Prof. Neville Osborne)

  Two month placement before going onto my postdoctoral studies- learnt techniques involved in retinal research.

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  Albert Einstein College of Medicine

  Jan 1999 - Mar 2004

  Postdoctoral Fellow (Mentor: Prof. Ales Cvekl)

  1. Employed a broad range of cellular assays that required generation of multiple mammalian recombinant plasmids and cell lines (e.g., CHO), to assess normal and mutant transcription.2. Identified target genes of master control gene of eye development through cDNA microarrays.

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  Cincinnati Children's Hospital Medical Center

  Apr 2004 - Aug 2013

  Senior Research Associate

  Primarily laboratory research, including:1. Applied functional genomics, including conditional knockout and over-expression approaches, to decipher the mechanisms underlying small molecule-induced changes in target protein levels.2. Interrogated impact of small molecules on downstream protein levels to uncover the molecular regulation of such changes in ocular morphogenesis by pharmacological manipulation of embryonic ocular tissues, followed by immunostaining and confocal microscope techniques.3. Generated 3D cultures of embryonic lens and lens cells in Matrigel for manipulation by active myosin-based enhancers/inhibitors. Show less

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  University of Pittsburgh School of Medicine

  Sept 2013 - Aug 2021

  Assistant Professor

  1. Analyzed comparative transcriptomes generated from RNA-Seq technologies to (i) uncover the cause of congenital corneal opacities in a rare disease patient and (ii) obtain the genetic diagnosis of an unusual case of bilateral cataracts unresolved from standard clinical genetic-testing.2. Analyzed convergent regression of ocular genes and enhancers.3. Implemented the use of stable cell reporter lines and designed CRISPR knock-ins in vivo to investigate regulation of target protein levels.4. Wrote federal research grants and manuscripts, in addition to being a reviewer of manuscripts and grants.5. Collaborated with clinical teams to write protocols, ICFs, and CSRs.6. Proofread for writing and training compliance with GCP and internal processes and policies. Show less

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  Clinical Research Strategies, LLC

  Jan 2022 - Oct 2023

  Clinical and Regulatory Affairs Scientist

  1. Led and collaborated with the client to write the protocol, IB, ICF, accompanying study-related documents and annual study reports in primarily the development of medical devices, and drugs.2. Collaborated with the medical team of the client to create literature reviews, abstracts and publications.3. Cooperated with the CRS regulatory team to write and manage modules for NDAs, MAAs, BLAs, PMAs, INDs, IDEs, HDEs, de Novo, and CERs, particularly Modules 2.3-2.7, 4.2, 5.2-5.4.4. Assisted with FDA regulatory submissions (e.g., Q-Subs, 501ks, IDEs, etc.)5. Wrote FDA, EMA, and Health Canada briefing documents.6. Developed RPAs and A-RPAs for clients.7. Ensured sign-off of versions by Clients.8. Coordinated quality control reviews of documents and maintained audit trails of changes.9. Assisted Quality Assurance with CAPAs, SOP revisions, audits, and inspections.10. Provided input on data analysis planning and interpretation.11. Ensured consistent use of writing tools and training materials and compliance with standardprocesses, policies, and procedures. Show less

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  All In One

  Oct 2023 - now

  Freelance Medical Writer

  1. Cooperate with clients to write regulatory documents for clinical trials - protocol, IB, ICF, CSR, and annual study reports in the development of drugs/biologics/medical devices.2. Work with third-party vendors to create literature reviews, abstracts and publications.3. Assist with FDA regulatory submissions (e.g., Q-Subs, 501ks, IDEs, etc.)4. Collaborate with the regulatory team of the client to write and manage the eCTD (e.g., for NDAs, MAAs, BLAs, PMAs, INDs, IDEs, HDEs and clinical evaluation reports (CERs)) - Modules 2.3-2.7, 4.2, 5.2-5.4 in particular.5. Develop Regulatory Pathway Assessments (RPAs) for clients.6. Ensure sign-off of versions by clients.7. Coordinate quality control reviews of documents and maintaining audit trails of changes.8. Assist Quality Assurance with SOP revisions.9. Provide input on scientific data analysis and its planning.10. Ensure consistent use of writing tools and training materials and compliance with standard processes, policies, and procedures. Show less