Program Manager, Regulatory Medical Writing

🕒 il y a 1 mois

🌐 Royaume-Uni, Grèce, +3 autres pays – Distant

🇬🇧 Royaume-Uni – Télétravail 🇬🇷 Grèce – Télétravail 🇫🇷 France – Télétravail 🇭🇺 Hongrie – Télétravail 🇳🇱 Pays-Bas – Télétravail

⏰ Temps Plein

🟠 Senior

🔴 Expert

📋 Responsable de Programme

👻 Score fantôme 16%

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.

Postuler Maintenant

Trouver des Emplois à Distance Similaires

Configurer une alerte email pour les nouveaux emplois

📊 Vérifiez votre score de CV pour ce poste

Améliorez vos chances d'obtenir un entretien en vérifiant votre score de CV avant de postuler.

Télécharger le CV

Thermo Fisher Scientific

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 1956

🏥 Santé

📦 Logistique

🏭 Fabrication

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific est le leader mondial dans le service aux sciences, avec un chiffre d'affaires annuel de plus de 40 milliards de dollars. Leur mission est de permettre à leurs clients de rendre le monde plus sain, plus propre et plus sûr en soutenant la recherche en sciences de la vie, en résolvant des défis analytiques complexes, en augmentant la productivité des laboratoires et en améliorant la santé des patients grâce aux diagnostics et au développement de thérapies révolutionnaires. Avec une équipe mondiale, ils offrent des technologies innovantes et des services pharmaceutiques à travers des marques telles que Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon et PPD.

Description

• Develop project timelines, standards, budgets, forecasts and contract modifications for assigned projects. • Serves as liaison with other departments on contract modifications. • Assist business development and senior management on securing new business at program levels by developing and making presentations to clients, leading the development and review of proposal texts and budgets, and supporting contract negotiations. • Serve as point of contact for risk escalation for assigned programs. • Evaluates and appropriately escalates or resolves risks to project quality, budget, or timeline. • Ensure compliance with quality processes and requirements for assigned programs both within and between documents within a project. • Develops, reviews and manages performance metrics for assigned projects. • Provide training for medical writers on processes and technical aspects of program management. • May serve as backup medical writer. Duties could include researching, writing and editing clinical study reports and protocols, summarizing data from clinical studies, writing or providing input on complex clinical and scientific documents such as IBs, INDs, and MAAs, and providing senior review of project materials.

🎯 Exigences

• Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years). • Experience in managing and directing complex medical writing projects required. • Experience working in the pharmaceutical/CRO industry preferred. • Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous. • Solid program management skills to include budgeting, forecasting and resource management. • Extensive knowledge of global, regional, national and other document development guidelines. • In-depth knowledge in one or more specialty areas such as preclinical, therapeutic, regulatory, submissions, communications, etc. • Excellent negotiation skills. • Self-motivated and adaptable. • Excellent judgment; high degree of independence in decision making and problem solving. • Capable of mentoring and leading junior level staff.

🏖️ Avantages

• When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. • You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference. • Accessibility/Disability Access We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.