FSP Program Manager – Medical Writing

🕒 vor 29 Tagen

🇬🇧 Vereinigtes Königreich – Remote

⏰ Vollzeit

🟠 Senior

🔴 Experte

📋 Programmmanager

👻 Geisterscore 12%

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🗣️🇺🇸🇬🇧 Englisch erforderlich

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Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

10.000+ Mitarbeiter

Gegründet 1956

🏥 Gesundheitswesen

📦 Logistik

🏭 Fertigung

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific ist der weltweite Marktführer im Dienste der Wissenschaft mit einem Jahresumsatz von mehr als 40 Milliarden US‑Dollar. Ihre Mission ist es, Kunden dabei zu unterstützen, die Welt gesünder, sauberer und sicherer zu machen – indem sie die lebenswissenschaftliche Forschung vorantreiben, komplexe analytische Herausforderungen lösen, die Produktivität in Laboren steigern und die Gesundheit von Patienten durch Diagnostik sowie die Entwicklung lebensverändernder Therapien verbessern. Mit einem globalen Team bietet das Unternehmen innovative Technologien und pharmazeutische Dienstleistungen über Marken wie Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon und PPD.

Beschreibung

• Lead client programs with high visibility among internal and client teams • Manage client relationships and identify and resolve client management issues • Manage and ensure timely delivery and quality of multiple program documents • Develop, monitor, and adapt project plans, client and program-specific processes, timelines, and budgets/forecasting • Serve as subject matter expert for assigned programs • Develop project timelines, standards, budgets, forecasts and contract modifications • Liaise with other departments on contract modifications • Assist business development and senior management in securing new business at program levels • Develop and deliver client presentations • Lead development and review of proposal texts and budgets • Support contract negotiations • Serve as point of contact for risk escalation and evaluate, escalate, or resolve risks to project quality, budget, or timeline • Ensure compliance with quality processes and requirements across assigned programs and project documents • Develop, review and manage performance metrics • Provide training for medical writers on processes and technical aspects of program management • May serve as backup medical writer, including researching, writing and editing clinical study reports and protocols • Summarize data from clinical studies • Write or provide input on complex clinical and scientific documents such as IBs, INDs, and MAAs • Provide senior review of project materials

🎯 Anforderungen

• Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification • Advanced degree preferred • 8+ years of previous experience providing the knowledge, skills, and abilities to perform the job • Experience managing and directing complex medical writing projects • Experience working in the pharmaceutical/CRO industry preferred • Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous • Equivalency through a combination of appropriate education, training and/or directly related experience may be considered • Solid program management skills, including 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 interpersonal, oral and written communication, and presentation skills • Excellent negotiation skills • Self-motivated and adaptable • Excellent judgment and a high degree of independence in decision making and problem solving • Capable of mentoring and leading junior level staff

🏖️ Vorteile

• Collaboration and development opportunities • Opportunity to contribute to scientific excellence and meaningful breakthroughs

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