Medical Writer - Narratives

FTINDDDBLR Fortrea Development India Private Limited_BLR; Bengaluru; On-site; INR 600,000 - 900,000; Full time

Job summary

Fortrea Development India Private Limited in Bengaluru is seeking a Medical Writer responsible for preparing and reviewing patient safety narratives and CSR appendices, and supporting protocol and CSR development under senior guidance.

You will ensure timely delivery of high-quality documents to internal teams and sponsors, follow Fortrea SOPs, and maintain strong client relationships while adhering to ICH guidelines. 1–2 years narrative writing experience and MS Word proficiency are expected.

Qualifications

• Minimum degree in life sciences or equivalent.
• Advanced degree (Master/PhD) preferred.
• 1–2 years of narrative writing experience.
• Excellent written and spoken English.
• Strong written and verbal communication skills.
• MS Word proficiency.
• Strong organizational and time-management abilities.
• Excellent interpersonal skills.
• Scientific or clinical research experience desirable.

Responsibilities

• Prepare and review patient safety narratives.
• Provide project management support for narrative projects.
• Prepare CSR appendices.
• Prepare synoptic or abbreviated CSRs under supervision.
• Support preparation of study protocols and CSRs.
• Ensure documents meet Fortrea/Client SOPs and ICH guidelines.
• Incorporate review comments on clinical documentation.
• Communicate with clients to meet project goals.
• Adhere to Fortrea processes and procedures.
• Perform other duties as assigned.

Skills

Narrative writing

English language proficiency

Written and verbal communication

Interpersonal skills

Time management

Education

Bachelor's degree in Life Sciences

Advanced degree (Masters/PhD) preferred

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.

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At Fortrea, we're all about turning the “impossible” into "I'm possible." Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence. Regardless of your role, we're all family, working together to achieve extraordinary results. At Fortrea, your career isn't just a job – it's a journey of making the exceptional possible, every day.