Sr Medical Writer

At Thermo Fisher Scientific, you’ll 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.

In Biostatistics and Programming, we are passionate about data and technical agility to drive enhanced value for our customers and patients. Determined to improve patient health, we provide statistics, programming and clinical pharmacology expertise through global delivery, consistent quality adherence and scientific insight. Through a procedural framework based on robust planning and specifications, we deliver clinical trial planning and development programs, results of a study and lead the regulatory submissions.

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. May assist 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 andstudy 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.

• Bachelors 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 ina 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.

Thermo Fisher Scientific values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• May require travel. (Recruiter will provide more details.)