Dr. Rajendra Jinwal

Experience

• 

  Medical jobs updates

  Jan 2004 - Nov 2004

  Research Officer

  I started my professional journey with this organization and started conducing Medical examination of the subjects during the screening to ensure that patient is eligible into the trial. Besides that, I was responsible for monitoring and reporting of adverse event to sponsor, ethics committee and regulatory authority on regular basis. Performed pulmonary function tests (PFTs) as an efficacy assessment parameter for the study as per time & event schedule.

• 

  MACLEODS PHARMACEUTICALS LTD.

  Mar 2005 - Jan 2007

  Medical Officer (Designated Principle Investigator)

  Phase I-BA/BE Studies:• Planned and conducted clinical phase of BA/BE Studies, Prepared protocols and ICF for clinical studies as per ICH–GCP guidelines. Conducted Medical examination of the subjects during screening to ensure that healthy and eligible subjects are included in the study. Monitored the drug dosing activity, vital and ECG monitoring, checked and recorded pathology reports and X-ray. While working here, I have successfully managed and completed DCGI, IDA & WHO auditsPhase II & III Clinical Trials:• Designed and submitted protocols, ICF, Investigator Brochure (IB) and Patient Information Sheet (PIS). Arranged, facilitated and managed site initiation visit after IEC/IRB approval. Conducted initial start-up meeting with Investigators and Ethics committee Show less

• 

  Tata Consultancy Services

  Jan 2007 - Jun 2010

  Team Leader Medical Writing

  I have served this organization for about 3 years and headed Medical Writing team to deliver high quality regulatory clinical documents. Assessed the performance of the team members on assigned projects by generating quality metrics scores based on the overall evaluation. I have also implemented Quality Management System (QMS) to deliver the high-quality documents to the client, Risk Management Plan (RMP) to identify and mitigate the risks anticipated for the betterment of the process.Other than this I have supported Business Development (BD) team for any new Request for proposal (RFPs) from the new customers by providing valuable inputs from domain perspective (MW) Show less

• 

  Novartis Oncology

  Jun 2010 - Sept 2018

  In this position, I managed timeliness, efficiency and quality of clinical documents assigned to the team. Served as Program Writer for programs and managed one of the biggest programs in Oncology. Implemented processes and metrics to meet global standards in collaboration with functional leads. Served as Safety Risk Management Plan Lead & coordinated RMP related activities in collaboration with PV and Medical Safety teams, Instrumental in Safety Management Team (SMT), SIGDET and MSRB meetings including preparatory activities. Show less

  • Group Head

    Sept 2015 - Sept 2018

  • Manager (Senior Medical Writer II)

    Sept 2011 - Sept 2015

  • Senior Medical Writer-I

    Jun 2010 - Sept 2011
• 

  Novartis

  Sept 2018 - Sept 2023

  Senior Group Head

  As a senior group head, my key responsibilities are; Functional and Operational Manager and overseeing project information flow to assigned teams, ensuring effective development of individuals, Organizational Talent Review, coaching/mentoring, objectives setting, performance review and compensation planning of assigned teams. Innovation and Operations lead including vendor management.

• 

  Novartis Oncology

  Oct 2023 - now

  Clinical Development Medical Director