Medical Writer - Narratives

Fortrea; Bengaluru; On-site; INR 600,000 - 750,000; Full time

Job summary

Fortrea in Bengaluru, India, seeks a Medical Writer to prepare and review patient safety narratives and CSR appendices, and assist with background writing for clinical study protocols and CSRs. You will ensure timely delivery of high-quality documentation to internal customers and Sponsors.

The role supports more senior staff in drafting synoptic CSRs under guidance, adheres to Fortrea standards and industry guidelines, and collaborates with clients to meet project goals while maintaining

Qualifications

• Minimum of first degree in life sciences (or equivalent).
• Advanced degree (e.g., PhD or Masters) preferred.

Responsibilities

• 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 Fortrea/Client SOPs and guidelines.
• Incorporate review comments on clinical documentation as guided.
• Communicate with clients to facilitate project goals.
• Comply with Fortrea internal processes and procedures.
• Perform other duties as assigned by Management.

Skills

Communication

English

Time management

Interpersonal skills

Attention to detail

Education

Bachelor's degree (Life sciences)

Advanced degree (PhD/Masters)

Tools

MS Word

Job description

Job Overview

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.

Summary Of Responsibilities

• 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 Fortrea/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 Fortrea internal processes and procedures.
• Performs other duties as assigned by Management.

Qualifications (Minimum Required)

• Minimum of first degree in life sciences (or equivalent).
• Advanced degree (e.g., PhD or Masters) preferred.

Experience (Minimum Required)

• 1-2 Years of Narrative writing experience
• 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.

Physical Demands/Work Environment

• Regularly required to sit.
• Overtime and weekend work as required.

Learn more about our EEO & Accommodations request here.