Covance Associate Medical Writer in Bangalore, India
Work Location: Bangalore
Responsible for preparation and review of clinical documents such as patient safety narratives and clinical study report (CSR) appendices. Responsible for preparing lower complexity documents such as synoptic or abbreviated CSRs under guidance of more senior staff. Assist Medical Writers in the preparation and background writing of clinical study protocols, CSRs, and subject narratives.
Ensure timely delivery of high quality documents to internal customers and Sponsors. Assist Medical Writers in the archiving and filing of clinical study protocols and CSRs and associated documentation. Foster excellent working relationships with all clients, both internal and external, with the highest quality of service in a cost-effective manner on time, every time
Essential Job Duties:
These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties.
Prepare and review patient safety narratives
Provide support to project management of narrative projects
Prepare and compile CSR appendices
Prepare lower complexity documents such as synoptic or abbreviated CSRs, and skeleton CSRs, under guidance of more senior staff as appropriate.
Provide support to more experienced colleagues with the preparation of clinical study protocols and CSRs
Prepare documents in accordance with Covance/Client Standard Operating Procedures and specifications as applicable, and relevant ICH and regulatory/industry guidelines
Under guidance, incorporate internal and/or external review comments on clinical documentation
Communicate with internal/external clients as needed to facilitate achievement of project goals
Comply with Covance internal processes and procedures
Performs other duties as assigned by Management
Minimum of first degree in life sciences (or equivalent); advanced degree (e.g., PhD or Masters) preferred
Excellent command of written and spoken English
Good written and verbal communication skills
Knowledge of MS Word
Good organizational and time management ability
Excellent interpersonal skills
Scientific or Clinical research experience desirable
Job Number 2018-16971
Job Category Clinical Operations
Position Type Full-Time
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