Senior Medical Writer (Early Development) - EMEA

at  Thermo Fisher Scientific

JOB DESCRIPTION

At Thermo Fisher Scientific, you will discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner, and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
As a Senior Medical Writer within the Early Development team, you will provide high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients.

EDUCATION AND EXPERIENCE:

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) is advantageous.

KNOWLEDGE, SKILLS, AND ABILITIES:

• 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).

• 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 (Phase 1, 1b and 2a)
• 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.