FSP Senior Regulatory Medical Writer (Remote; US)

Work Schedule Standard (Mon-Fri) Environmental Conditions Office

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. Summarized Purpose: We are excited to expand our Medical Writing Functional Service Partnership (FSP) Team and are seeking candidates based in the US! 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. Essential Functions:

• 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.

Education and Experience: Bachelor's degree in a scientific field 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. If CRO experience: experience working in a client-dedicated role or with 1-2 clients over multiple projects is preferred. Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous. 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
• In-depth knowledge in a specialty area such as preclinical or regulatory submissions, 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).

What We Offer: At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development program, ensuring you reach your potential. As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We have grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel. Our Mission is to enable our customers to make the world healthier, cleaner, and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need. Apply tot his job