Posted 109 months ago
Writer
@ INKspire
Toronto, Ontario
Overview
INKspire is hiring a full-time medical writer to prepare clinical regulatory documents such as clinical study reports, investigator brochures and registration dossier modules. The role involves writing, editing and reviewing clinical content and managing medical writing projects within cross-functional teams. The posting requires Microsoft Office, Adobe Acrobat and document management system skills.
Responsibilities:
- Prepare and review clinical regulatory documents such as CSRs, IBs and CTD modules
- Interpret clinical data and apply regulatory and scientific requirements
- Participate in medical writing and cross-functional project teams
- Manage medical writing projects from planning through preparation
Requirements summary:
- Ability to prepare clinical regulatory documents with minimal supervision
- Knowledge of company guidelines and international regulations
- Proficiency in Microsoft Office, Adobe Acrobat and document management systems
- Excellent oral and written communication and project management skills
Tools & skills
Source and dates
Employer career site / ATS feed · smartrecruiters
- Employer posting date
- 2017-11-27
- First seen by our source
- 2026-10-15
- Source record updated
- 2026-10-15
These dates describe the source record, not a live verification that the employer is still hiring. Check the original posting.
Job details
| Department | Physicians & advanced practice |
| Hours per week | 40 (estimated) |
| Work setting | Office |
| Position | Mostly sitting |
| Physical demands | physical low · computer high |
| Languages | English |
Summary and details written by AI from the posting; the employer’s posting is the authority.
INKspire
| Field | Value |
|---|---|
| Open jobs on Jobsy | 2 |
Job Description
· Is a capable scientific contributor and subject matter expert in preparation of selected regulatory clinical documentation.
· Applies developing knowledge of regulatory medical writing and therapeutic area/investigational product to support pipeline projects. Participates as part of the medical writing team in cross-functional teams.
· Demonstrates competence in writing, editing and reviewing of clinical study reports, investigator brochures, registration dossier modules, and other clinical regulatory documents in line with expectations.
· Able to interpret data and apply knowledge of regulatory/compliance/scientific requirements to document preparation.
· Manages medical writing projects including the design, planning, and preparation of clinical documentation in support of clinical development, trials, and sections of filings.
Qualifications
· Ability to prepare, with minimal supervision a subset of clinical regulatory documents (e.g., CSR, IB, clinical sections of IND/IMPD and CTD) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format in keeping with industry guidelines
· Participate actively in medical writing and cross-functional project teams.
· Technical expertise in Microsoft Office, Adobe Acrobat, document management systems, and familiarity with SharePoint and concepts of structured content management.
· Excellent oral (including presentation) and written communication, and project management skills. Awareness of pharmaceutical industry needs beyond clinical development.
Additional Information
All your information will be kept confidential according to EEO guidelines.
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