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Senior Clinical Scientist
Innovaderm Research Inc.. Author and contribute to clinical and regulatory documents, including study protocols, statistical analysis plans, clinical study reports, narratives, abstracts, posters, and manuscripts .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical and regulatory writing, including the preparation of study protocols, statistical analysis plans, and clinical study reports, while ensuring compliance with Good Clinical Practices and regulatory requirements. Proven ability to manage projects, mentor staff, and contribute to organizational improvements in a client-focused environment.
Highest-signal resume keywords
Clinical Research ExperienceRegulatory Document WritingStatistical AnalysisProject ManagementGood Clinical Practices Knowledge
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical WritingStatistical AnalysisData InterpretationDocument Quality ControlStudy Design ContributionLiterature SearchProposal DevelopmentIND Submission SupportAdvanced Word SkillsAdvanced Excel Skills
Soft Skills
Strong English CommunicationExcellent Attention to DetailClient-Focused AttitudeInterpersonal SkillsLeadership
Tools & Technologies
Microsoft WordMicrosoft ExcelMicrosoft PowerPoint
Industry Keywords
Drug Development ProcessRegulatory RequirementsHealth Canada RegulationsFDA GuidelinesClinical Research Organization
About the role
Key responsibilities & impact- Author and contribute to clinical and regulatory documents, including study protocols, statistical analysis plans, clinical study reports, narratives, abstracts, posters, and manuscripts
- Contribute to study design and review informed consent forms
- Review statistical analysis plans and tables, figures, and listings
- Review, analyze, and interpret study data
- Perform online literature searches
- Prepare and review training materials for scientific teams and the company
- Manage medical writing deliverables, stakeholder communication, project issues, and timelines
- Provide scientific, therapeutic, and medical writing expertise during study conduct
- Mentor and train new and junior staff
- Perform quality-control reviews of documents prepared by team members
- Support delivery of scientific affairs commitments on time, within budget, and in compliance with SOPs and regulations
- Contribute to organizational improvements and implementation of new processes and procedures
- Participate in QA or client audits as a scientific subject-matter expert
- Support business development with proposal synopses, bid-defense content, sponsor meetings, and sponsor questions
- Review scientific-affairs assumptions and budgets during RFPs
- Provide scientific support and medical writing for pre-IND and IND submissions
- Provide scientific expertise and potentially lead cross-functional projects
- Perform other assigned responsibilities when qualified and trained
Requirements
What you’ll need- MSc in a related field of study or combination of relevant education and work experience
- Minimum of 6 years of clinical research experience
- 3 years in writing clinical/regulatory documents and analyzing and reporting study data in CRO/pharmaceutical industry
- In-depth knowledge of drug development process and applicable regulatory requirements
- Strong English communication skills
- Advanced English writing skills
- Strong proficiency in Word, Excel, and PowerPoint, with advanced skills formatting large documents
- Ability to handle varied and multiple tasks and prioritize workload
- Excellent attention to detail
- Client-focused attitude
- Excellent interpersonal skills and teamwork
- Quick learner, adaptable, and versatile
- Leadership and ability to positively influence others
- Good knowledge of Good Clinical Practices and applicable Health Canada and FDA regulations/guidelines
- Must be legally authorized to work in Canada
Benefits
Comp & perks- Permanent full-time position
- Flexible schedule
- Vacation
- Home-based position
- Ongoing learning and development
- Medical, dental, and vision insurance
- Retirement plan
- Personal days
- Virtual medical clinic
- Public transit discounts
- Social activities
- Attractive advancement opportunities