Associate Report Writer - Mississauga, Ontario
2 days ago
Job description
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.
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