Senior Medical Writer, Promotional Review

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🕒 vor 2 Monaten

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $130.000 - $150.000 / Jahr

⏰ Vollzeit

🟠 Senior

🏥📝 Medizinischer Autor

🦅 H1B-Visum-Sponsor

Dieses Unternehmen hat in der Vergangenheit H1B-Visa gesponsert.

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Thermo Fisher Scientific

WebsiteLinkedInAlle Stellen

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

• Provides high-quality medical review for promotional and non-promotional collateral against local standards, best practices and FDA-OPDP requirements. • Support medical information writing activities such as drafting and/or reviewing Standard Response Letters, FAQs, and product Dossiers. • Collaborating with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence. • Reviews promotional and non-promotional materials for clinical and scientific accuracy against source documentation, reviews context and tone of language for compliance with FDA-OPDP requirements and assures appropriate level of language for intended audience. • Provides strategic rationale for suggested changes and language. • Provides input on and independently develops best practices, methods and techniques for achieving optimal results, including various client specific processes.

🎯 Anforderungen

• PharmD Degree, or similar. • Equivalent of 2-3-years working experience in the review of promotional medical collateral as part of a Medical/Legal/Regulatory (MLR) Team or Promotional Review Committee • Strong background in Veeva PromoMats and related PRC CRM-based platforms. • Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills • Strong project management skills • Excellent interpersonal skills including problem solving • Strong negotiation skills • Excellent oral and written communication skills with strong presentation skills • Significant knowledge of global, regional, national and other relevant guidelines • In-depth knowledge across therapeutic specialty areas. • Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)

🏖️ Vorteile

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs • Employee assistance and family support programs, including commuter benefits and tuition reimbursement • At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy • Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan • Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount