Medical Writer - Narratives

Fortrea; Mumbai; On-site; INR 600,000 - 900,000; Full time

Job summary

Fortrea in Mumbai, India is seeking a junior Medical Writer to prepare and review clinical documents, including patient safety narratives and CSR appendices, under guidance. You will support narrative project management, draft synoptic CSRs, and assist senior staff with protocols and CSRs, ensuring timely delivery to sponsors.

Strong English, MS Word skills, and good organizational ability are essential. The role offers exposure to regulatory writing standards and cross-functional collaboration

Qualifications

• Bachelor's degree in life sciences or equivalent.
• 1–2 years of narrative writing experience.
• Excellent written and spoken English.
• Good written and verbal communication skills.
• Knowledge of MS Word.
• Strong organizational and time management abilities.
• Excellent interpersonal skills.

Responsibilities

• Prepare and review patient safety narratives.
• Provide support to project management of narrative projects.
• Prepare and compile CSR appendices.
• Prepare lower complexity documents under guidance of senior staff.
• Support preparation of clinical study protocols and CSRs.
• Follow SOPs and regulatory guidelines; incorporate review comments.
• Communicate with clients and internal teams to meet project goals.
• Adhere to Fortrea processes and procedures.

Skills

Narrative writing

English communication

Verbal communication

MS Word

Time management

Interpersonal skills

Education

Bachelor's degree in life sciences

Advanced degree (PhD or Masters) 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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