Senior Clinical Scientist

This is a fully remote position, open to applicants in Canada.

📋 Description

• Create and assist in the development of clinical and regulatory documents, such as study protocols, statistical analysis plans, clinical study reports, narratives, abstracts, posters, and manuscripts.

• Contribute to the design of studies and evaluate informed consent forms.

• Assess statistical analysis plans along with tables, figures, and listings.

• Analyze and interpret study data.

• Conduct online literature reviews.

• Develop and review training materials for scientific teams and the organization.

• Oversee medical writing deliverables, communication with stakeholders, project challenges, and timelines.

• Offer scientific, therapeutic, and medical writing expertise throughout the study process.

• Mentor and train new and junior personnel.

• Conduct quality-control assessments of documents prepared by team members.

• Ensure the timely delivery of scientific affairs commitments, adhering to budget constraints and compliance with SOPs and regulations.

• Facilitate organizational enhancements and the adoption of new processes and procedures.

• Engage in QA or client audits as a scientific subject-matter expert.

• Support business development efforts with proposal summaries, bid-defense materials, sponsor meetings, and responses to sponsor inquiries.

• Review scientific-affairs assumptions and budgets during RFPs.

• Provide scientific support and medical writing for pre-IND and IND submissions.

• Offer scientific expertise and potentially lead cross-functional projects.

• Undertake additional responsibilities as qualified and trained.

⛳️ Requirements

• MSc in a relevant field or a combination of pertinent education and work experience.

• At least 6 years of experience in clinical research.

• Minimum of 3 years writing clinical/regulatory documents and analyzing and reporting study data within the CRO/pharmaceutical sector.

• Comprehensive understanding of the drug development process and relevant regulatory requirements.

• Excellent English communication skills.

• Advanced English writing capabilities.

• High proficiency in Word, Excel, and PowerPoint, with advanced formatting skills for large documents.

• Ability to manage diverse tasks and prioritize workload effectively.

• Exceptional attention to detail.

• Client-oriented mindset.

• Strong interpersonal skills and ability to work collaboratively.

• Quick learner who is adaptable and versatile.

• Demonstrated leadership skills and the ability to positively influence others.

• Solid knowledge of Good Clinical Practices and relevant Health Canada and FDA regulations/guidelines.

• Must possess legal authorization to work in Canada.

🏝️ Benefits

• Permanent full-time employment.

• Flexible working hours.

• Vacation time.

• Remote work opportunity.

• Continuous learning and development opportunities.

• Comprehensive medical, dental, and vision insurance.

• Retirement savings plan.

• Personal days off.

• Access to a virtual medical clinic.

• Discounts on public transportation.

• Social engagement activities.

• Attractive opportunities for career advancement.