Opportunity for Medical Writer to work in TCS | M.Pharm, B.Pharm, Ph.D

TCS has been a pioneer in BPS. This key strategic division - powered by a unique combination of deep domain expertise, process excellence and innovative technology world-class solutions across diverse industries. With a talent pool of over 50,000 resources, BPS has state-of-the-art delivery centers spread across India, Hungary, Ecuador, Chile, Uruguay, UK, USA and China.

Post : Medical Writer

Job Responsibilities
1. QC of Regulatory documents (including but not limited to CSR, Narratives, CTD Modules, Investigator’s Brochure, Protocol, DSUR, PSUR)
2. Ensure that the QC’ed documents are in accordance with the company SOPs, guidelines and agreed timelines and comply with established standards and performance metrics
3. Perform the project management activities for the project/ document assigned
4. Develop and maintain effective working relationships and facilitate communication among the project team members
5. Identify issues and implement corrective and preventive action.
6. Impart trainings and mentor and groom the new incumbents, develop therapeutic area and document expertise

Educational Qualification
· Doctors (MBBS, BAMS, BHMS, BDS, MD/MS, PhD) and/or Graduate or post graduate in Pharmacy, Nursing or life sciences
· Certificate in Medical writing or Diploma in clinical research would be desirable
· Peer review experience of at least one year is desirable

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Preferred experience
· 2 to 3 years’ experience in Medical writing
· Knowledge of drug development and ICH/GCP guidelines
· Experience of working with EDMS system.
· Good knowledge of US and EU regulatory requirements.
· Exposure to multiple therapeutic areas
· Excellent written and verbal communication skills and ability to present and critically discuss clinical data in both internal and external discussions.
· Experience in analysis, interpretation and reporting the scientific data (analytical thinking)

Additional Information:
Experience: 2 to 3 years
Qualification: B. Pharm, M.Pharm, MBBS, BAMS, BHMS, BDS, MD/MS, PhD
Location: Mumbai
Job Id : 112401
Industry Type: Pharma/Biotech/Clinical Research
End Date: 30^th Oct, 2017