Senior Scientist-Human Pharmacology

Description

• Overall adherence to safe practices and procedures of oneself and the teams aligned
• Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company’s integrity & quality standards
• Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
• Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
• Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self
• Compliance to Syngene’ s quality standards at all times
• Hold self and their teams accountable for the achievement of safety goals
• Govern and Review safety metrics from time to time
• Role Accountabilities
  • Independently develop and finalize clinical and scientific documents for different regulatory submissions such as (but not limited to) Bioanalytical reports, Clinical Study Reports (CSRs), part of Electronic Common Technical Document (eCTD) modules, covering various therapeutic areas, and phases of clinical research
  • Collaborates with internal and external clients to support and enable effective communication resulting in operational excellence
  • Effectively manages medical writing and review processes to deliver quality projects in agreed timelines
  • Ensure compliance with applicable regulatory guidelines, department SOPs, client style guides, conventions as applicable
  • Ensures that appropriate documented quality control (QC) checks are performed on medical writing deliverables and responds to findings
  • Follow any other instructions and perform any other related duties, as assigned by the supervisor.
  • Performs literature search/review as necessary to obtain background information for developing scientific content

Qualifications

• Good communication
• Quick learner
• Adapt to change
• Time management
• Professionalism

Technical/functional Skills

• Ability to comprehend scientific information
• Good understanding of clinical research.
• Knowledge of working on MS word, PPT etc.
• Attend training on environment, health, and safety (EHS) measures imparted company

Education

• Graduate/Masters in Life Sciences