Senior Medical Writer

Emploi pas sur LinkedIn

🔥 il y a 15 heures

🌵 Arizona, Connecticut, +10 états de plus – Distant

🌵 Arizona – Remote 🦌 Connecticut – Remote 🐊 Florida – Remote 🌽 Illinois – Remote 🗻 New Hampshire – Remote 🏖️ New Jersey – Remote 🌲 North Carolina – Remote 🍂 Massachusetts – Remote 🏰 Missouri – Remote 🔔 Pennsylvania – Remote ⛷️ Utah – Remote ⚔️ Virginia – Remote

💵 $84 368 - $120 526 / an

⏰ Temps Plein

🟠 Senior

🏥📝 Rédacteur Médical

👻 Score fantôme 0%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Perceptive Inc.

Site WebLinkedInTous les Emplois

1001 - 5000 employés

🏥 Santé

💼 Conseil

📦 Logistique

Healthcare • Consulting • Logistics

Perceptive Inc. est un fournisseur de premier plan de solutions scientifiques et basées sur les données pour l'industrie bio-pharmaceutique, se concentrant sur les domaines thérapeutiques de l'oncologie, du système nerveux central (SNC) et de l'imagerie musculo-squelettique. Grâce à son expertise en découverte de médicaments, en imagerie préclinique et clinique précoce, et en radiochimie, Perceptive propose des services qui identifient les candidats prometteurs et atténuent les risques grâce à ses services d'imagerie de premier ordre. Elle offre également des solutions eClinical complètes, y compris la gestion de la randomisation et de l'approvisionnement des essais (RTSM), visant à optimiser les processus des essais cliniques. Reconnue pour la haute qualité de ses données, Perceptive se positionne comme un partenaire pour faire avancer les essais cliniques et apporter plus rapidement des traitements essentiels aux patients, soutenue par plus de 50 ans d'expérience et une équipe d'experts dévoués. La présence mondiale de Perceptive assure une prestation fluide des services de découverte, eClinical et d'imagerie pour soutenir les essais cliniques à l'échelle mondiale.

Description

• Create, research, edit and coordinate production of clinical documents related to independent review • Prepare clinical documents for submission to regulatory authorities • Prepare clinical documents not intended for regulatory submission • Revise drafts based on review comments from team members • Follow SOPs, templates, guidelines, regulations, client instructions and applicable processes • Perform literature searches and reviews for background information and training • Draft or ghost-write clinical documents for more experienced medical writers • Support team members to ensure documentation is accurate and meets stakeholder needs • Participate in process improvement and training initiatives, including development of SOPs, central content, guidelines and workflow procedures • Participate in marketing initiatives such as white papers, abstracts, posters and manuscripts • Serve as primary client contact for medical writing projects • Negotiate deliverable timelines and resolve project-related issues • Represent medical writing on assigned project teams and facilitate authoring team meetings • Coordinate and conduct interdepartmental reviews of draft and final documents • Evaluate task progress, identify issues, facilitate resolutions and advance documents to approval • Distribute final documents to project teams and clients on agreed timelines • Identify project challenges and raise them with stakeholders, suggesting resolution options • Attend project team meetings and maintain project documentation • Provide project management of contractual and financial aspects when required • Implement stakeholder engagement and communications plans • Manage problems, issues, resolutions, corrective actions and lessons learned • Collect and use stakeholder feedback to measure relationship-management effectiveness • Develop and enhance customer and stakeholder relationships • Develop, maintain, control and distribute documents using systematic quality methods • Prepare documents for publishing readiness and ensure consistency and integrity • Ensure documentation adheres to FDA, EMA and other applicable regulatory guidelines and SOPs • Perform medical editing reviews of draft and final documents, including copyediting and content review • Control updates and distribution of quality standards • Carry out other reasonable duties as requested

🎯 Exigences

• Bachelor's Degree in a technical discipline (Science, pharmacy, nursing, or other health-related discipline preferred etc.) or a related study, or equivalent project-related experience • Fluent English, written and verbal • Non-English language, written and verbal, desirable • Solid professional experience in the same or very similar role • Experience of regulatory documents in a contract research organization, pharmaceutical or biotechnology firm, or some experience in the conduct of clinical research/medical communications • Experience working in and knowledge of the life sciences sector • Solid knowledge of industry guidelines and regulations, including ICH-GCP • Experience of regulated environments • Understanding of Agile methodologies • Experience using tools to communicate progress to stakeholders • Proven ability to use Microsoft Office products, including Word, Excel and PowerPoint • Demonstrable ability to apply critical thinking to problems and tasks • Ability to consistently produce documents of high quality • Ability to manage multiple and varied tasks and prioritize workload with attention to detail • Ability to work methodically in a fast-paced, time-sensitive environment • Ability to identify and implement process improvements • Ability to negotiate on behalf of medical writing to align resources, timelines and expectations • Up-to-date awareness of trends, tools, technology, techniques, processes and documentation requirements affecting technology within the life sciences domain • Ability to work under own initiative • Experience using data analysis tools such as Tableau or Power BI desirable

🏖️ Avantages

• Medical, Dental and Vision benefits for you and your family • Flexible Spending Accounts (FSA) • Health Savings Accounts (HSAs) • Paid time off policy including holidays and sick time • Internal growth and development programs & trainings • 401(k) program • Life & accident insurance • Disability insurance