Job Description

Lead writer independently responsible for the preparation of clinical study protocols and clinical study reports (CSRs), and other documents as needed for lower complexity studies. Provides support to more experienced writers with the preparation of clinical study protocols and CSRs, and other clinical documents as needed. Interpretation of clinical, pharmacokinetic, pharmacodynamic and statistical results as appropriate. Responsible for preparation and review of clinical documents such as patient safety narratives and CSR appendices. Ensure timely delivery of high-quality documents to internal customers and Sponsors. Provision of training for Associate Medical Writers and other staff as appropriate. 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.

of Responsibilities:

• Independently prepare lower complexity protocols and CSRs including interpretation of clinical data and statistical results as appropriate.
• Work with more experienced colleagues in the development of higher complexity protocols and CSRs, and other clinical documents as needed.
• Independently prepare and review patient safety narratives.
• Provide support and project management of narrative projects.
• Prepare and/or oversee compilation of CSR appendices.
• Prepare documents in accordance with Fortrea/Client Standard Operating Procedures and specifications as applicable, and relevant ICH and regulatory/industry guidelines.
• Independently review Statistical Analysis Plan (SAP) and Tables, Figures and Listings (TFLs) for assigned studies to ensure appropriate data presentation for CSR purposes. Provide feedback on SAP and TFLs to project team as needed.
• Incorporate internal and/or external review comments on clinical documentation.
• Communicate with internal/external clients as needed to facilitate achievement of project goals.
• Participate in meetings with internal and external clients, with guidance and support from colleagues.
• Lead meetings as appropriate.
• Responsible for project coordination and adherence to project timelines and budget, as appropriate.
• Represent department in inter-department working groups.
• Provide training and guidance to Associate Medical Writers and other staff as appropriate.
• Comply with Fortrea internal processes and procedures.
• Performs other duties as assigned by Management.

Qualifications (Minimum Required):

• First degree in life sciences (or equivalent).
• Advanced degree (e.g., PhD or Masters) preferred.

Experience (Minimum Required):

• Typically, minimum 1 years medical writing experience or 2 years professionally-related experience.
• 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.
• Scientific or Clinical research experience desirable.
• Good scientific writing skills.
• Understanding of medical, pharmacokinetic, and statistical principles.

Physical Demands/Work Environment:

• Office environment.

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