Associate Report Writer

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 people’s 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 PMRI’s 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.