Clinical Scientist, Dermatology & Rheumatology CRO, Canada

DescriptionThe Clinical Scientist is responsible for medical writing activities at Indero. The individual will author or contribute to development of clinical and regulatory documents (synopsis, study protocols, statistical analysis plans, clinical study reports), as well as scientific publications.This role will be perfect for you if:You are a strong medical writer with demonstrated ability to produce high-quality scientific documents to support clinical research.You enjoy learning continuously and keeping yourself informed.Having an impact within a growing company with momentum motivates you. RESPONSIBILITIESIs accountable for own medical writing deliverables, including quality, stakeholder communication, resolution of project issues, and timeline management;Collaborates to clinical development of Phase 1/First-in-Man studies, Proof of Concept (POC) trials, Phase 2b – 3 studies, and Phase 4/registry trials.Contributes to study design and writes/reviews clinical study protocols/amendments;Reviews informed consent/assent forms, study reference manuals, statistical analysis plans, and mock shells of statistical tables/figures/listings;Reviews, analyzes, and interprets study data based upon scientific expertise and industry standard practices;Writes/reviews narratives and clinical study reports;Prepares scientific abstracts, posters, and manuscripts;Performs on-line literature searches;Provides documents with high quality in terms of scientific content, organization, clarity, accuracy, format and consistency;May perform quality control review of documents prepared by other team members;Participates in process improvement efforts of the department.RequirementsIDEAL PROFILEEducation MSc in life sciences; PhD is an asset;Experience Experience in writing clinical / regulatory documents such as study protocols and clinical study reports;Experience analyzing and reporting on study dataKnowledge and skillsGood knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.Good knowledge of drug development process;Advanced English writing skills; strong English communication skills; French is an asset;Strong proficiency of Word;Ability to handle varied and multiple tasks, organize own work, and prioritize workload;Has excellent attention to detail;Client-focused attitude;Quick learner, good adaptability, and versatile.Our companyThe work environmentAt Indero, formerly Innovaderm, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. In this position, you will be eligible for the following perks: Flexible work schedule Permanent full-time position BenefitsOngoing learning and development About InderoIndero, formerly Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe. Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.Indero only accepts applicants who can legally work in Canada.Description de posteLe Scientifique clinique est responsable des activités de rédaction médicale chez Indero. Cette personne rédigera ou contribuera à l'élaboration de documents cliniques et réglementaires (synopsis, protocoles d'études, plans d'analyses statistiques, rapports d'études cliniques), ainsi que de publications scientifiques.Ce poste sera parfait pour vous si :Vous êtes un rédacteur médical expérimenté avec une habileté démontrée à produire des documents scientifiques de haute qualité pour supporter la recherche clinique.Vous aimez apprendre continuellement et vous garder informé sur les nouveautés dans le domaine.Avoir un impact au sein d’une compagnie en pleine croissance et en pleine lancée vous motive.RESPONSABILITÉSEst responsable de ses propres livrables de rédaction médicale, y compris la qualité, la communication avec les parties prenantes, la résolution des problèmes du projet et la gestion du calendrier;Collabore au développement clinique des études de phase 1/essais de première administration (FIM), des essais de preuve de concept (POC), des études de phase 2b - 3 et des essais de phase 4.Contribue à la conception de l'étude et rédige et examine les protocoles et amendements des études cliniques;Révise les formulaires de consentement éclairé et d'assentiment, les manuels de référence des études, les plans d'analyse statistique et les coquilles simulées des tableaux/figures/listes statistiques;Révise, analyse et interprète les données d'étude en