Job Title

Pharma Medica Research (PMRI) Inc. is a Contract Research Organization that strives for innovation and original solutions in a highly regulated and competitive industry. If your career goals align with innovation and original thinking you will be the perfect candidate to be part of an inclusive, adaptable, and forward-thinking organization. Our reputation for delivering high quality research is outstanding. At PMRI we are committed to making a difference in healthcare and peoples lives. Come join our team! We are currently looking for an Associate Report Writer to join our team for a one year contract, which may be extended. Duties and Responsibilities: Create appendices to CSRs using various prescribed sources. Publish appendices to CSRs by applying Optical Character Recognition (OCR), bookmarks, hyperlinks, table of contents, and pagination. Make modifications to subject source documents originating from PMRIs clinical site, including such modifications as applying OCR, redactions, and bookmarks. Archive Trial Master File (TMF) documents in accordance with PMRI SOPs. Create hard copy versions of study reports based on client requests. Enter data and review clinical documentation to ensure accuracy and consistency. Use report format templates, checklists, and training manuals relating to CSR creation. Prepare additional electronic files as required by Regulatory Agencies (e.g., FDA BE Summary Tables, EMA Module 2.7.1 Tables). Other duties as required. Requirements Associate Degree in life sciences related discipline or related field is required. Previous pharmaceutical experience is an asset. 1 year of report writing experience in a CRO environment an asset. Basic knowledge of International Conference on Harmonization (ICH), Good Clinical Practice (GCP) guidelines, and other applicable regulatory rules and guidelines. Solid writing and editorial skills. High degree of self-motivation. Ability to work efficiently and independently under pressure. Ability to work as a team player and with the team dynamics. Excellent interpersonal and oral communication skills. Proficiency in computer usage and software applications. We offer: Competitive compensation plan Opportunities for advancement and career progression A generous Employee Milestones Awards Program Corporate Discounts Program Friendly atmosphere, culture of learning Please note all applications must be eligible to work within Canada. PMRI is an Equal Opportunity Employer; promoting accessibility and inclusivity at work and offering accommodation for applicants as required and requested.