Medical Writer II-CDS

Job Overview:

Lead writer responsible for preparation of clinical study protocols and clinical study reports (CSRs), and other clinical documents as needed. Provides support to more experienced writers with the preparation of complex clinical documents. Interpretation of clinical, pharmacokinetic, pharmacodynamic and statistical results as appropriate. Production of scientific publications and other documents (e.g. abstracts, posters, manuscripts, etc). Oversees and coordinates other writers on CSR appendices compilation and narrative projects. Prepare and review patient safety narratives and CSR appendices. Ensure timely delivery of high-quality documents to internal customers and Sponsors. Works with the management team to provide training to Medical Writers to ensure best working practices are maintained. 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:

• Prepares protocols and CSRs, including interpretation of clinical data and statistical results as appropriate.
• Work under guidance from colleagues to assist development of protocols, CSRs and other clinical documents on complex studies and programs.
• Prepare and review patient safety narratives.
• Leads project management and coordination of narrative projects.
• Oversee and coordinate other writers on CSR appendices compilation.
• Prepare documents in accordance with Fortrea/Client Standard Operating Procedures and specifications as applicable, and relevant ICH and regulatory/industry guidelines.
• Participate in review of Statistical Analysis Plan (SAP) and Tables, Figures and Listings (TFLs) to ensure appropriate data presentation for CSR purposes. Provide feedback on SAP and TFLs to project team as needed.
• Incorporates internal and/or external review comments on clinical documentation.
• Prioritize and forward plan workload to a high standard; to advise Management of problems promptly.
• Participate independently in internal and external client meetings.
• Lead meetings as appropriate.
• Responsible for project coordination and adherence to project timelines and budget.
• Identify ways to improve the efficiency and quality of work processes.
• Mentor Associate Medical Writers and Medical Writer I, as appropriate.
• Provide peer review and input on deliverables prepared by colleagues, as appropriate based on experience.
• Provide training to Medical Writers and other staff as appropriate.
• Represent department in audits and inter-department working groups.
• 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):

• Typically, minimum 3 years medical writing experience including 1 year as medical writing project lead.
• Excellent command of written and spoken English.
• Good written and verbal communication skills.
• In-depth knowledge of MS Word.
• Good organizational and time management ability.
• Excellent interpersonal skills.
• Knowledge of ICH guidelines applicable to medical writing.
• Good understanding of medical/scientific terminology and experience in data analysis and interpretation.

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