Principal Medical Writer

Work Schedule

Environmental Conditions

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.

Provides high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients. As the lead writer, reviews documents for the team and provides training and guidance to junior team members. Provides advice on document development strategy, regulations and industry best practices. Demonstrates subject matter and therapeutic area expertise. Acts as backup program manager. Collaborates with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.

Key Responsibilities:

• Researches, writes, and edits clinical study reports and study protocols, and 
summarizes data from clinical studies.
• May serve as primary author who writes and provides input on complex clinical and scientific and program level documents, including IBs, INDs, and MAAs.
• Provides senior level review of routine and complex documents. Provides training and mentorship for other 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. As the subject matter expert, develops and reviews best practices, methods and techniques for achieving optimal results, including various clientspecific processes, and leads process improvement initiatives. May also develop, review and manage performance metrics for assigned projects.
• May serve as backup program manager. Identifies and resolves out-of-scope 
activities. Duties could include developing timelines, budgets, forecasts and 
contract modifications, and assisting business development with client 
presentations and proposal text review, and attending bid defense meetings and capabilities presentations.
• Represents the department at project launch meetings, review meetings, and 
project team meetings.

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 8+ years).
Experience in managing and directing complex medical writing projects required
Experience working in the pharmaceutical/CRO industry preferred
Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous

Knowledge, Skills, and Abilities:

• Significant knowledge of global, regional, national and other document development guidelines
• In-depth knowledge in one or more specialty areas such as preclinical, therapeutic, regulatory, submissions, communications, etc.
• Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
• Excellent project management skills
• Advanced interpersonal, oral and written communication, and presentation skills
• Excellent negotiation skills
• Excellent judgment; high degree of independence in decision making and problem solving
• Ability to mentor and lead junior level staff.

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 programme, 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. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.