Innovaderm Research Inc.
Innovaderm Research Inc.
Innovaderm Research Inc. yra į dermatologiją orientuota klinikinių tyrimų sutarčių tyrimų organizacija (CRO), remianti klinikinį vystymą nuo I iki IV fazės. Nuo 2000 m. įmonė bendradarbiauja su farmacijos ir sveikatos priežiūros organizacijomis Šiaurės Amerikoje ir Europoje, teikdama dermatologijos tyrimų planavimo, reguliavimo konsultacijų, projektų valdymo, pacientų pritraukimo ir duomenų valdymo paslaugas.

Senior Clinical Scientist – Canada Remote

Senior Clinical Scientist supporting clinical and regulatory writing for Indero, a global dermatology and rheumatology CRO. The role covers study design, data interpretation, regulatory submissions, and scientific team support.

Aprašymas

  • Develop and contribute to clinical and regulatory materials, including protocols, statistical analysis plans, clinical study reports, narratives, abstracts, posters, and manuscripts
  • Support study design activities and review informed consent forms
  • Evaluate statistical analysis plans and associated tables, figures, and listings
  • Analyze, interpret, and review clinical study data
  • Conduct searches of relevant online literature
  • Create and review training resources for scientific teams and the wider organization
  • Coordinate medical writing deliverables, stakeholder communications, project issues, and timelines
  • Provide scientific, therapeutic-area, and medical writing expertise throughout study conduct
  • Mentor and train new and junior team members
  • Conduct quality-control reviews of documents prepared by colleagues
  • Help deliver scientific affairs commitments on schedule, within budget, and in accordance with SOPs and regulations
  • Support organizational enhancements and the introduction of new processes and procedures
  • Participate in quality assurance or client audits as a scientific subject-matter expert
  • Assist business development through proposal synopses, bid-defense materials, sponsor meetings, and responses to sponsor questions
  • Assess scientific affairs assumptions and budgets during RFP activities
  • Provide scientific and medical writing support for pre-IND and IND submissions
  • Offer scientific leadership and, where appropriate, lead cross-functional projects
  • Complete other assigned duties for which qualified and trained

Reikalavimai

  • Master’s degree in a related discipline or an equivalent combination of relevant education and professional experience
  • At least six years of experience in clinical research
  • At least three years writing clinical or regulatory documents and analyzing and reporting study data in a CRO or pharmaceutical environment
  • Thorough understanding of the drug development lifecycle and relevant regulatory requirements
  • Strong written and verbal English communication skills
  • Advanced English-language writing ability
  • Advanced proficiency in Word, Excel, and PowerPoint, including formatting complex, lengthy documents
  • Ability to manage diverse concurrent assignments and prioritize workload effectively
  • Exceptional attention to detail
  • Client-oriented approach
  • Strong interpersonal and collaborative skills
  • Adaptable, versatile, and able to learn quickly
  • Demonstrated leadership and ability to influence others constructively
  • Working knowledge of Good Clinical Practice and applicable Health Canada and FDA regulations and guidance
  • Legally authorized to work in Canada

Privalumai

  • Permanent full-time employment
  • Flexible working schedule
  • Vacation entitlement
  • Home-based work arrangement
  • Continuing learning and development opportunities
  • Medical, dental, and vision coverage
  • Retirement plan
  • Personal days
  • Virtual medical clinic
  • Public transit discounts
  • Social activities
  • Opportunities for career advancement

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