Sunil Kumar Reddy Khambam

About Sunil Kumar Reddy Khambam

My professional summary in brief; •Prepared research protocols in the therapy areas of cardiology, psychiatry, pain, circulation, oncology and gastrointestinal system.•Prepared informed consent forms and case record forms.•Prepared clinical study reports.•Devised non-invasive pain model methods which are simple, safe, reproducible and cost effective’ can be used in early phases of clinical trials i.e, Phase I, to determine the efficacy of the test product under study. Also, designed and developed novel method of inducing pain using hot air.•Worked with a biomedical engineer to construct pain model methods. This apparatus significantly decreased the labor when working on early human studies.•Published research work.•Designed and published non-invasive assessment of microvascular circulation using laser Doppler flowmetry technique.•Worked as team with senior resident staff in the comparison of simultaneous measurements of central aortic pressures measured during the routine diagnostic cardiac catheterization and recording of the non-invasive brachial cuff blood pressure to generate a central aortic pressure estimate using Applanation Tonometry in patients undergoing routine diagnostic left heart catheterization.•Supervised, trained and mentored students in the lab. Taught students to conduct non-invasive experiments on healthy subjects (i.e, positioning of the subjects during conduct of experiments, recording of the study related parameters, to determine variability in the recordings) and to analyze the results.•Trained students during workshop in the development of non-invasive pharmacodynamic methods in the area of pain and psychiatry.

Experience

1. Senior Scientific Writer Ii

   百时美施贵宝

   Dec 2023 — Present · IN

   Authors complex clinical documents [eg, Investigator\'s Brochures (IB), Protocols, Phase 2/3 Clinical Study Reports (CSR), briefing documents, Common Technical Document (CTD) summary documents, responses to Health Authority queries] for timely submission to health authorities worldwide according to:o good documentation principles (organization, clarity, scientific standards)o consistency between text and tabular presentations or graphical displayso in compliance with BMS documentation standards and worldwide regulatory requirements• Participate in relevant document subteam(s) and ensure effective planning and management of timelines for all components of assigned documents.• Participate in document strategy sessions, including messaging, document flow, logic, and consistency for assigned projects.• Participate in document prototyping sessions, including document flow, logic, and consistency for assigned project prototypes, and maintain document prototypes and shells. • Comply with internal and external processes and guidelines while managing the review process and, on an ongoing basis, resolve issues, errors, or inconsistencies with pertinent team members to ensure:o optimal communication between authoring team and development team memberso coordination and efficient use of messages between internal development plans, IND and Marketing Authorization documentationo timely completion and high quality of assigned documents• Review and edit documents as required.• Serves as a liaison for external documentation support (when required), prepares specifications for the work, and ensures maintenance of good documentation principles as well as BMS documentation standards.• Leads and influences a diverse group of authors of regulatory documents from a variety of disciplines without a reporting relationship.

Education

• Vignana Jyothi Junior College

  Intermediate, Bi.P.C

  1995 — 1997

• Nizam's Institute of Medical Sciences

  Doctor of Philosophy (Ph.D.), CLINICAL PHARMACOLOGY & THERAPEUTICS

  2008 — 2013

• Narayana Medical College

  M.Sc, MEDICAL PHARMACOLOGY

  2004 — 2007

• Nizam's Institute of Medical Sciences

  Ph.D, Pain

  2008 — 2013

• Horsely Hills School

  Metriculation, 10 standard

  1991 — 1995

• Sri Venkata Padmavathi Institute of Medical Sciences

  B.P.T; BACHELOR, PHYSIOTHERAPY

  1999 — 2004

Skills

• Microsoft Word
• Medical Writing
• CRO
• Clinical Research
• Clinical Pharmacology
• Gcp
• Clinical Trials
• Teaching
• Protocol
• Clinical Study Design
• Clinical Development
• Powerpoint
• Microsoft Excel
• Ich-Gcp
• Microsoft Office