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Principal Medical Writer - Oncology/ Le Rédacteur Médical Principal
Company | Merck |
Address | Toronto, Ontario, Canada |
Employment type | FULL_TIME |
Salary | |
Category | Medical Equipment Manufacturing,Research Services,Pharmaceutical Manufacturing |
Expires | 2023-10-02 |
Posted at | 8 months ago |
- Provide leadership of and management for complex documentation projects and project teams of medical writers.
- Produces high-quality and timely documentation in line with expectations. Interprets and applies knowledge of regulatory/compliance/scientific requirements, using own judgment, prior work experience, and broad appreciation of impact on other disciplines.
- Solves complex problems associated with medical writing scope of work, involving ambiguous situations across departments and the need to develop new options to resolve.
- Oversees the work of other medical writers, providing scientific and operational mentorship and coaching in the design, planning, and execution of their assignments. Provides feedback to their managers on development plans and performance reviews.
- Leads and manages medical writing projects including the design, planning, and preparation of clinical documentation in support of clinical development, trials (e.g., pivotal CSRs), and filings (e.g., clinical modules). Works collaboratively with colleagues across functions to achieve results.
- Applies in-depth knowledge of regulatory medical writing and therapeutic area/investigational product to support pipeline projects. Represents functional area in cross-functional team (either internally or externally).
- Provides leadership for medical writing processes, standards, and initiatives.
- Is recognized as a significant scientific contributor and subject matter expert in preparation of regulatory clinical documentation.
- Bachelor’s degree with 10+ years; or MS with 8+ years; or PhD with 5+ years of relevant career experience.
- Degree in the Life Sciences.
- Excellent oral (including presentation) and written communication, and project management skills. Awareness of pharmaceutical industry needs beyond clinical development.
- 5-10 years of experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry. Ability to prepare, without supervision, any type of clinical regulatory document (e.g., protocol, CSR, CIB, clinical sections of IMPD and CTD) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format in keeping with industry guidelines.
- Technical expertise in Microsoft Office, Adobe Acrobat, document management systems, and familiarity with SharePoint and concepts of structured content management.
- Est reconnu(e) comme un(e) contributeur/-rice scientifique important(e) et un(e) expert(e) en la matière dans la préparation de la documentation clinique réglementaire.
- Assure la direction des processus, des normes et des initiatives en matière de rédaction médicale.
- Produit une documentation de haute qualité et opportune conformément aux attentes. Interprète et applique sa connaissance des exigences réglementaires/conformités/scientifiques en utilisant son propre jugement, son expérience professionnelle et une large appréciation de l'impact sur les autres disciplines.
- Dirige et gère des projets de rédaction médicale, y compris la conception, la planification et la préparation de la documentation clinique à l’appui du développement clinique, des essais ex : les rapports sur la sécurité chimique essentiels) et des dépôts de documents (ex : des modules cliniques). Travaille en collaboration avec des collègues de toutes les fonctions pour obtenir des résultats.
- Résout des problèmes complexes associés à l’étendue du travail de rédaction médicale, impliquant des situations ambiguës entre les services et la nécessité de développer de nouvelles options pour les résoudre.
- Applique une connaissance approfondie de la rédaction médicale réglementaire et du domaine thérapeutique / produit de recherche pour soutenir les projets en attente. Représente le domaine fonctionnel dans une équipe interfonctionnelle (en interne ou en externe).
- Supervise le travail d’autres rédacteurs médicaux, en leur fournissant un encadrement scientifique et opérationnel et en les guidant dans la conception, la planification et l’exécution de leurs missions. Fournit une rétroaction à leurs responsables sur les plans de développement et les évaluations du rendement.
- Diplôme en sciences de la vie.
- Baccalauréat avec au moins 10 ans d’expérience professionnelle pertinente ou maîtrise avec au moins 8 ans d’expérience professionnelle pertinente ou doctorat avec au moins 5 ans d’expérience professionnelle pertinente.
- Excellentes compétences en matière de communication orale (y compris les présentations) et écrite, et de gestion de projet. Connaissance des besoins de l’industrie pharmaceutique au-delà du développement clinique.
- Assurer la direction et la gestion de projets de documentation complexes et d’équipes de rédacteurs médicaux.
- 5 à 10 ans d’expérience en tant que rédacteur/-rice médical(e) préparant des documents réglementés dans l’industrie pharmaceutique et/ou biotechnologique. Capacité à préparer, sans supervision, tout type de document réglementaire clinique (protocole, rapport sur la sécurité chimique, CIB, sections cliniques de dossier de produit médicinal expérimental et de document technique commun) conformément aux directives de l’entreprise et aux réglementations gouvernementales internationales et à présenter les données cliniques de manière objective dans un format clair et concis, conformément aux directives de l’industrie.
- Expertise technique dans Microsoft Office, Adobe Acrobat, les systèmes de gestion de documents, et connaissance de SharePoint et des concepts de gestion de contenu structuré.
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