Biorasi Hiring Lead, Medical and Scientific Affairs

Biorasi Hiring Lead, Medical and Scientific Affairs

13 May, 2022

About the job

Come join our Asia office!

We are looking for an Lead Medical and Scientific Affairs in Mumbai, India

We are Biorasi – become part of our team:

  • Biorasi is an innovative and fast-growing global CRO
  • We are international: Our headquarters is in Aventura, Florida. Other locations are in Germany, India, Russia and Ukraine.
  • Communication & Hands-on mentality: We value open and transparent communication within the company and support our teams at all times
  • Development and worklife balance: We want our employees to develop personally as well as professionally

Your tasks:

  • Assist in the design and conduct of clinical trials including the development of first draft and review of protocols and amendments
  • Assist the study Primary Medical Monitor in assigned studies and act as backup Medical Monitor
  • Support to investigator, site, and internal training
  • Support taking medical and safety meeting notes, updating trackers Assist with minimal supervision in answering safety and protocol related questions and review literature
  • Help preparing material and case studies for DMC meetings and Sponsor calls
  • Provide Sites with the knowledge to properly evaluate subjects and adhere to the protocol
  • Lead in medical review, assessment, and interpretation of clinical and safety data to ensure that the data are correct and presented with the appropriate medical interpretation
  • Escalate any critical safety concerns to the study Medical Monitor as well as sponsor, and coordinate between sites and Medical Monitor/sponsor
  • Work closely with Medical Monitor and Safety and Pharmacovigilance team to provide medical input into safety reports including, SAE narratives and analysis of similar events, Development Safety Update Reports (DSURs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) reports, and Company Core Safety Information (CCSI)
  • Responsible for the review of individual data with SAEs and potentially clinically important laboratory test results or vital sign abnormalities and escalate issues to the Medical Monitor as needed
  • Assist in medical and scientific review of deliverables such as CSR
  • Follow international GCP guidelines/regulations and SOPs for executing clinical studies
  • Lead in developing and maintaining SOPs, Templates, and study plans
  • Assist with any Audit response that may occur

Your Profile:

  • Medical degree, MD, DO or its international equivalent.
  • Fluent English (oral and written)
  • 1-3 years’ experience within the pharmaceutical industry or related field
  • Keen knowledge and understanding of ICH GCP
  • Excellent verbal, written communication and presentation skills.
  • Critical Thinking and background medical and scientific research
  • Strong proficiency in using Microsoft Office
  • Experience with safety databases (ARISg, Oracle Argus, etc.) and/or EDC system (IBM, Medrio, Medidata) a plus

We are looking forward to your application. Please send us your CV either via the application button.

Apply through this Link

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