Medical Writer

TCS - Mumbai, Maharashtra (30+ days ago)

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Preferred

Educational Qualification for the role:
·
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

Preferred

experience for the role:
·
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)

Reporting to:
Team Leader Designee: Delivery
Manager

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,