Clinical Study Report Writer

Pharma Medica Research is a full service contract research organization specialized in conducting early phase clinical trials in healthy volunteers, special and patient populations. We look for top talent to expand their knowledge and develop their skills in our exciting environment.

We are currently looking for a Report Writerthat is looking to learn and advance their skills to join our team!

The Report Writer writes clinical, analytical, efficacy, and statistical sections of Phase I-III studies. This position reports to Supervisor, Report Writing and/or designate.

Responsibilities:

• Responsible for all aspects of study and summary reports including clinical, analytical and statistical.
• Use report format templates, check lists, and Training Manual.
• If applicable, review clinical documentation in a timely manner.
• Compile clinical documentation and complete data entry, when required.
• Prepare additional electronic files as required by Regulatory Agencies (e.g., eCTD, CSBE, FDA BE Summary Tables, EMA Module 2.7.1 Tables, SwissMedic).
• Prepare correspondence to sponsors and ensure the shipment of the final report.
• Prepare study documentation for long term archiving.
• Other duties as required.

Education and Experience:

• Completed a university or college level degree (BS or BScH)
• Knowledge of the pharmaceutical industry is an asset
• Previous pharmaceutical experience is an asset.
• Fluent in English (spelling and grammar)
• Strong computer skills in Microsoft office programs
• Knowledge of ADOBE software an asset
• Ability to work with minimum supervision
• Excellent interpersonal, written, and oral skills

If you meet the needs of this position, apply today!