Medical Writer - Narratives

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.