Description de poste
Le scientifique clinique principal est responsable de la rĂ©daction ou de la contribution au dĂ©veloppement de documents cliniques et rĂ©glementaires (rĂ©sumĂ©s dâĂ©tudes, protocoles dâĂ©tudes, plans dâanalyse statistique, rapports dâĂ©tudes cliniques), ainsi que de publications scientifiques. Il soutient les Ă©quipes internes en fournissant son expertise scientifique lors de lâĂ©laboration de propositions pour de nouvelles opportunitĂ©s dâaffaires, ainsi que pendant la conduite des Ă©tudes.
De plus, le scientifique clinique principal aide lâĂ©quipe Ă respecter ses engagements dans les dĂ©lais prĂ©vus, dans le respect des budgets, des procĂ©dures opĂ©ratoires normalisĂ©es (SOP) et des exigences rĂ©glementaires. Il assure Ă©galement la formation et le mentorat des employĂ©s plus juniors.
Le scientifique clinique principal peut Ă©galement participer Ă des projets internes multidisciplinaires afin de soutenir diverses initiatives dâamĂ©lioration des processus au sein de lâentreprise.
Ce poste sera parfait pour vous si :
- Vous ĂȘtes un rĂ©dacteur mĂ©dical expĂ©rimentĂ© avec une habiletĂ© dĂ©montrĂ©e Ă produire des documents scientifiques de haute qualitĂ© pour supporter la recherche clinique.
- Vous aimez apprendre continuellement et vous garder informé sur les nouveautés dans le domaine.
- Avoir un impact au sein dâune compagnie en pleine croissance et en pleine lancĂ©e vous motive.
RESPONSABILITĂS
Plus précisément, le scientifique clinique principal :
- Contribue Ă la conception des Ă©tudes et rĂ©dige/rĂ©vise les protocoles dâĂ©tudes cliniques;
- Révise les formulaires de consentement éclairé;
- RĂ©vise les plans dâanalyse statistique ainsi que les tableaux, figures et listings;
- RĂ©vise, analyse et interprĂšte les donnĂ©es dâĂ©tudes en sâappuyant sur son expertise scientifique et les pratiques standards de lâindustrie;
- RĂ©dige/rĂ©vise les rĂ©cits cliniques (narratives) et les rapports dâĂ©tudes cliniques;
- Prépare des résumés scientifiques, affiches (posters) et manuscrits;
- Effectue des recherches bibliographiques en ligne;
- PrĂ©pare et rĂ©vise le matĂ©riel de formation destinĂ© Ă lâĂ©quipe scientifique et Ă lâensemble de lâentreprise (p. ex. programme de formation en dermatologie, nouvelles aires thĂ©rapeutiques);
- Est responsable de ses propres livrables de rédaction médicale, incluant la qualité, les communications avec les parties prenantes, la résolution des enjeux liés aux projets et la gestion des échéanciers;
- Fournit des documents de haute qualitĂ© sur le plan du contenu scientifique, de lâorganisation, de la clartĂ©, de lâexactitude, du format et de la cohĂ©rence;
- Fournit une expertise scientifique pendant la conduite des études sur les projets assignés;
- Agit à titre de mentor et assure la formation des nouveaux employés ou des employés plus juniors;
- Effectue la rĂ©vision du contrĂŽle de la qualitĂ© des documents prĂ©parĂ©s par dâautres membres de lâĂ©quipe;
- Aide lâĂ©quipe des affaires scientifiques Ă respecter ses engagements dans les dĂ©lais prĂ©vus (p. ex. planification des livrables de projets pour les membres juniors de lâĂ©quipe), dans le respect du budget, des procĂ©dures opĂ©ratoires normalisĂ©es (SOP) et des rĂ©glementations applicables;
- Fournit une expertise thérapeutique et en rédaction médicale;
- Contribue Ă lâamĂ©lioration organisationnelle et participe activement Ă la mise en Ćuvre de nouveaux processus et/ou procĂ©dures;
- Peut participer Ă des audits qualitĂ© (QA) ou Ă des audits clients Ă titre dâexpert de contenu pour lâĂ©quipe scientifique;
- Soutient le dĂ©partement du dĂ©veloppement des affaires en rĂ©digeant/rĂ©visant des synopsis dâĂ©tudes pour les propositions, en dĂ©veloppant le contenu scientifique pour les rĂ©unions de dĂ©fense dâoffres (Bid Defense), en fournissant son expertise scientifique lors des rencontres avec les promoteurs (sponsors) ou en rĂ©pondant Ă leurs questions;
- Peut réviser les hypothÚses et les budgets liés au périmÚtre des affaires scientifiques dans le cadre de nouvelles opportunités lors du processus de demande de proposition (RFP);
- Maintient une connaissance Ă jour des pratiques de lâindustrie, des exigences rĂ©glementaires et des lignes directrices pertinentes; participe activement aux services-conseils en dĂ©veloppement clinique en fournissant un soutien scientifique et de la rĂ©daction mĂ©dicale pour les soumissions prĂ©-IND et IND;
- Fournit une expertise scientifique dans le cadre de projets transversaux et peut Ă©galement agir comme chef de projet pour de telles initiatives afin de soutenir lâatteinte des objectifs stratĂ©giques de lâentreprise.
Les employĂ©s peuvent se voir attribuer dâautres responsabilitĂ©s ne figurant pas dans la prĂ©sente description de poste, pourvu quâils possĂšdent lâexpĂ©rience requise, les qualifications nĂ©cessaires et/ou aient reçu la formation adĂ©quate.
Profil recherché
PROFIL RECHERCHĂ
Ăducation
- Maßtrise pertinente au domaine des sciences de la vie; un doctorat ou MD représente un atout.
Expérience
- Minimum de 6 années d'expérience dans la rédaction de documents cliniques/réglementaires (tels que le protocole d'étude et les rapports d'étude clinique) et dans l'analyse et la communication de données d'étude dans l'industrie CRO/pharmaceutique;
- Expérience en en analyse et communication des données d'étude;
Aptitudes et connaissances
- Bonne connaissance des bonnes pratiques cliniques et des rÚglements/lignes directrices applicables de Santé Canada et de la Food and Drug Administration (FDA).
- Bonne connaissance du processus de développement des médicaments;
- Excellentes compétences en rédaction anglaise; solides compétences en communication anglaise;
- Excellente maĂźtrise de Word;
- Capacité à gérer des tùches variées et multiples, à organiser son propre travail et à prioriser la charge de travail;
- Excellente attention aux détails;
- Attitude axée sur le client;
- Capacité à apprendre rapidement, bonne adaptabilité et polyvalent.
Notre entreprise
Lâenvironnement de travail
Chez Indero, vous travaillerez avec des collĂšgues compĂ©tents et dynamiques. Nos valeurs sont la collaboration, lâinnovation, la fiabilitĂ© et la rĂ©activitĂ©. Nous offrons un environnement de travail stimulant ainsi que de belles perspectives dâĂ©volution professionnelle.
Dans ce poste, vous bénéficierez des conditions suivantes :
- Horaire de travail flexible
- Poste permanent Ă temps plein
- Gamme complĂšte dâavantages sociaux (assurances mĂ©dicales, dentaires, vision, rĂ©gime de retraite, vacances, journĂ©es personnelles, clinique mĂ©dicale virtuelle, rabais sur le transport en commun, activitĂ©s sociales)
- Formation et développement continu
ï»żLieu de travail
La personne embauchĂ©e pourra travailler Ă distance de nâimporte quelle ville au Canada, ou depuis notre bureau principal Ă MontrĂ©al.
Des visites occasionnelles Ă notre siĂšge social pourraient ĂȘtre requises ou encouragĂ©es.
ï»żĂ propos dâIndero
Indero est une entreprise de recherche clinique contractuelle (CRO) spĂ©cialisĂ©e dans les essais cliniques. Depuis ses dĂ©buts, notre entreprise Ă taille humaine sâest forgĂ© une solide rĂ©putation pour la qualitĂ© de ses recherches et de ses services, surpassant les attentes de nos clients. BasĂ©e Ă MontrĂ©al, Indero poursuit sa croissance Ă travers lâAmĂ©rique du Nord et lâEurope.
Indero sâengage Ă offrir un traitement Ă©quitable et des chances Ă©gales Ă tous les candidats. Des accommodements peuvent ĂȘtre offerts Ă toute Ă©tape du processus de recrutement pour les personnes en situation de handicap, sur demande.
Indero nâaccepte que les candidatures de personnes lĂ©galement autorisĂ©es Ă travailler au Canada.
Le genre masculin est utilisĂ© sans discrimination, dans le seul but dâallĂ©ger le texte.
About The Position
The senior clinical scientist is responsible for authoring or contributing to development of clinical and regulatory documents (synopsis, study protocols, statistical analysis plans, clinical study reports), as well as scientific publications. The senior clinical scientist supports the internal team by providing scientific expertise during proposal stage for new opportunities, as well as during study conduct. In addition, the senior clinical scientist assists the team to deliver commitments on time, within budget and in compliance to SOPs and regulations, and provides training and mentoring for junior staff.
The senior clinical scientist may also participate in cross-functional internal projects to support different process improvement initiatives within the company.
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.
RESPONSIBILITIES
More specifically, the senior clinical scientist:
- Contributes to study design and writes/reviews clinical study protocols;
- Reviews informed consent forms;
- Reviews statistical analysis plans and 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;
- Prepares and reviews training material for the scientific team and for the whole company (e.g. Dermatology training program, new therapeutic areas);
- Is accountable for own medical writing deliverables, including quality, stakeholder communication, resolution of project issues, and timeline management;
- Provides documents with high quality in terms of scientific content, organization, clarity, accuracy, format and consistency;
- Provides scientific expertise during study conduct on assigned projects;
- Acts as mentor and provides training for new staff or for more junior staff;
- Performs quality control review of documents prepared by other team members;
- Contributes to study design and writes/reviews clinical study protocols;
- Reviews informed consent forms;
- Reviews statistical analysis plans and 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;
- Prepares and reviews training material for the scientific team and for the whole company (e.g. Dermatology training program, new therapeutic areas);
- Is accountable for own medical writing deliverables, including quality, stakeholder communication, resolution of project issues, and timeline management;
- Provides documents of high quality in terms of scientific content, organization, clarity, accuracy, format and consistency;
- Provides scientific expertise during study conduct on assigned projects;
- Acts as mentor and provides training for new staff or for more junior staff;
- Performs quality control review of documents prepared by other team members;
- Assists the scientific affairs team to deliver commitments on time (e.g. planning projects deliverability junior team members), within budget, and in compliance to SOPs and regulations;
- Provides therapeutic and medical writing expertise;
- Provides input in organizational improvements and actively participates in implementation of new processes and/or procedures;
- May participate in QA or client audit as subject matter expert for the scientific team;
- Supports the business development department by writing/reviewing study synopsis for proposals, by developing scientific content for Bid defense meeting, by providing scientific expertise during meeting with sponsors or by answering questions received from sponsors;
- May review assumptions and budget for scientific affairs scope of work for new opportunities during RFP process.
- Maintains familiarity with relevant current industry practices and regulatory requirements and guidelines; actively participates in clinical development consulting services by providing scientific support and medical writing for pre-IND and IND submission;
- Provides scientific expertise in cross-functional projects and may also act as project lead in such initiative to align with the company strategic objectives.
Employees may be assigned other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training.
Requirements
IDEAL PROFILE
Education
- MSc in a related field of study or combination of relevant education and work experience; PhD or MD is an asset;
Experience
- Minimum of 6 years of clinical research experience; with 3 years in writing clinical/regulatory documents (such as study protocol and clinical study reports) and analyzing and reporting study data in CRO/pharmaceutical industry;
Knowledge and skills
- In-depth knowledge of drug development process and applicable regulatory requirements;
- Strong English communication skills; advanced English writing skills;
- Strong proficiency of Word, Excel, and Power Point, with advanced skills formatting large documents;
- Ability to handle varied and multiple tasks, and prioritize workload;
- Has excellent attention to detail;
- Client-focused attitude;
- Team player with excellent interpersonal skills;
- Quick learner, good adaptability and versatile;
- Leadership and ability to positively influence others;
- Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.
Our company
At Indero, 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:
- Permanent full-time position
- Flexible schedule
- Vacation
- Home-based position
- Ongoing learning and development
About Indero
A Global Clinical Leader In Dermatology!
Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint.
Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ yearsâ experience in clinical research and trial delivery. Our full-service approach â which includes everything from protocol design and patient recruitment to trial monitoring and biometrics â provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale.
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.
