· 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 InformationAll your information will be kept confidential according to EEO guidelines.
Skills Required
- Ability to prepare clinical regulatory documents, including clinical study reports, investigator brochures, and clinical sections of IND, IMPD, and CTD filings, with minimal supervision
- Knowledge of company guidelines, international governmental regulations, and industry guidelines for clinical regulatory documentation
- Active participation in medical writing and cross-functional project teams
- Technical expertise in Microsoft Office and Adobe Acrobat
- Experience with document management systems and familiarity with SharePoint and structured content management concepts
- Excellent oral, presentation, and written communication skills
- Project management skills
- Awareness of pharmaceutical industry needs beyond clinical development
What We Do
INKspire is a youth-led nonprofit organization focused on amplifying young people’s voices through a safe, inclusive social platform and publication. It gives youth opportunities to share ideas, stories, writing, and perspectives; learn from peers; develop creative-writing skills; receive mentorship; and take leadership roles. Through interactive projects and programs, INKspire supports youth empowerment and helps young writers across Canada participate in and contribute to media.
