Senior Medical Writer

Job not on LinkedIn

October 31

Apply Now

Receive Emails with Similar Jobs

Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

Biotechnology • Pharmaceuticals • Science

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

📋 Description

• Provides high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients. • Demonstrates subject matter and therapeutic area expertise. • Assists program manager. • Collaborates with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence. • Serves as primary author who writes and provides input on routine documents such as clinical study reports and study protocols, and summarizes data from clinical studies. • May research, write or edit complex clinical and scientific and program level documents, including IBs, INDs, and MAAs. • Reviews routine documents prepared by junior team members. • May provide training and mentorship for junior writers and program managers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge. • Ensures compliance with quality processes and requirements for assigned documents. • Provides input on and independently develops best practices, methods and techniques for achieving optimal results, including various client specific processes. • May assist in program management activities. • Identifies and resolves out-of-scope activities. • Duties could include developing timelines, budgets, forecasts and contract modifications. • Represents the department at project launch meetings, review meetings, and project team meetings.

🎯 Requirements

• 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 5+ years). • Experience working in the pharmaceutical/CRO industry preferred • Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous • 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 document development guidelines • In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc. • Great judgment and decision-making skills • Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)

🏖️ Benefits

• Reasonable accommodation for individuals with disabilities