Senior Medical Writer - Remote (US Central/Pacific Time Zones)

Employment Type: Full-time Work Schedule: Standard (Mon-Fri) Environmental Conditions: Office Location Type: Remote

Position Overview

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.

We are excited to expand our Medical Writing Functional Service Partnership (FSP) Team and are seeking candidates based in the US Central or Pacific Time Zones! As a remote-based Senior Medical Writer within the FSP team, you will provide high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients. You will collaborate with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence. Our ideal candidate will possess the versatility to author both clinical and preclinical regulatory documents, with therapeutic area expertise in infectious diseases and/or oncology.

Responsibilities

• Serves as a primary author who writes and provides input on routine clinical documents such as clinical study reports and study protocols and summarizes data from clinical studies.
• Serves as a primary author who writes complex clinical and scientific and program level documents, including IBs, bioassay reports, INDs, and MAAs.
• Reviews routine documents prepared by early career team members.
• May provide training and mentorship for writers 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

• Education: Bachelor's degree in a scientific field or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred.
• Experience:
  • 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.
  • If CRO experience: experience working in a client-dedicated role or with 1-2 clients over multiple projects is preferred.
• Additional Qualifications: Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous.
• Equivalency: In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

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.

Application Instructions

(No specific application instructions were provided in the original text.)

Company Information

Thermo Fisher Scientific is dedicated to enabling our customers to make the world healthier, cleaner, and safer. Our PPD clinical research portfolio spans laboratory, digital, and decentralized clinical trial services, with trials conducted in 100+ countries. We are committed to supporting our teams in achieving their career goals and advancing scientific discovery.