Medical Writer - Narratives

Fortrea; Bengaluru; Sur place; INR 600 000 - 900 000; Plein temps

Résumé du poste

Fortrea in Bengaluru seeks a Medical Writer to prepare and review patient safety narratives and CSR appendices, and to assist with protocols and CSRs under guidance. The role ensures timely delivery of high-quality documents to internal customers and Sponsors, in line with SOPs and ICH guidelines.

Requirements include 1–2 years of narrative writing, a life sciences degree (advanced degree preferred), excellent English communication, and solid MS Word skills.

Qualifications

• 1–2 years of narrative writing experience.
• Excellent command of written and spoken English.
• Good written and verbal communication skills.
• Knowledge of MS Word.
• Strong organizational and time management abilities.

Responsabilités

• Prepare and review patient safety narratives.
• Provide support to project management of narrative projects.
• Prepare CSR appendices.
• Prepare lower complexity documents under guidance of more senior staff.
• Provide support to more experienced colleagues with preparation of clinical study protocols and CSRs.
• Communicate with internal/external clients to facilitate achievement of project goals.

Connaissances

Narrative writing

MS Word

English communication

Formation

Bachelor's degree in life sciences

Advanced degree (PhD or Masters) preferred

Description du poste

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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