Medical Writer – Narratives

Jobtailor; Bengaluru; On-site; INR 450,000 - 650,000; Full time

Job summary

Fortrea in Bengaluru is seeking an experienced clinical writing support professional focused on patient safety narratives and CSRs. You will prepare and review narratives, assist in CSR appendices, and help with protocol documentation under supervision.

The role emphasizes strong written English, attention to regulatory guidelines, and collaboration with internal and external clients to meet project timelines.

Qualifications

• First degree in life sciences; English proficiency; strong writing and communication skills; familiarity with MS Word.

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 under guidance.
• Support more experienced colleagues with preparation of clinical study protocols and CSRs.
• Prepare documents in accordance with Fortrea/Client SOPs and regulatory guidelines.
• Incorporate internal/external review comments on clinical documentation under guidance.
• Communicate with internal/external clients to facilitate project goals.
• Comply with Fortrea internal processes and procedures.
• Assist in archiving and filing of protocols, CSRs and related documentation.
• Perform other duties as assigned by Management.
• Ensure timely delivery of high-quality documents to internal customers and Sponsors.
• Foster excellent relationships with clients while providing cost-effective, on-time service.

Skills

Narrative writing

Clinical study reports

Written and verbal communication

Time management

MS Word

Education

Bachelor's degree in life sciences

Advanced degree (PhD or Masters)

Tools

MS Word

Job description

• 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


• Incorporate internal and/or external review comments on clinical documentation under guidance


• Communicate with internal/external clients as needed to facilitate achievement of project goals


• Comply with Fortrea internal processes and procedures


• Assist in the archiving and filing of clinical study protocols, CSRs, and associated documentation


• Perform other duties as assigned by Management


• Ensure timely delivery of high-quality documents to internal customers and Sponsors


• Foster excellent working relationships with internal and external clients while providing cost-effective, on-time service

Requirements

• Minimum of first degree in life sciences (or equivalent)


• Advanced degree (e.g., PhD or Masters) preferred


• 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


• Regularly required to sit

Core Competencies

Demonstrates expertise in preparing and reviewing clinical documentation, including patient safety narratives and clinical study reports, while adhering to regulatory guidelines and internal procedures. Strong communication and organizational skills are essential for effective collaboration with internal and external clients.

Highest-signal resume keywords

• Narrative Writing Experience


• Clinical Study Report Preparation


• Knowledge of MS Word


• Excellent Written and Verbal Communication


• Life Sciences Degree

Hard Skills

• Patient Safety Narratives


• Clinical Study Reports


• CSR Appendices Preparation


• Document Preparation


• Regulatory Guidelines Compliance

Soft Skills

• Good Organizational Ability


• Excellent Interpersonal Skills


• Time Management Skills

Industry Keywords

• ICH Guidelines


• Clinical Research


• Fortrea Standard Operating Procedures


• Internal Processes Compliance