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Principal Medical Writer – Client Embedded (FSP)

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 be expanding our Medical Writing FSP Team in North America (NA). This would be a remote role working from any location in NA. We are seeking a talented and expert Principal Medical Writer to be dedicated to a client in the FSP space; experience in oncology and leading submissions would be valuable. The Lead Medical Writer will have the responsibility of developing exceptional clinical and regulatory documents, ensuring compliance with all regulatory standards and company guidelines.

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 sophisticated clinical and scientific and program level documents, including IBs, INDs, and MAAs.
• Provides senior level review of routine and sophisticated 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 client-specific 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 field or equivalent and relevant formal academic / vocational qualification required; Advanced degree preferred. 
• Regulatory writing experience that provides the knowledge, skills, and abilities to perform the role (comparable to 8+ years). 
• Experience in handling and advising sophisticated medical writing projects required.
• Experience working in the pharmaceutical/CRO industry required. 
• 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. 

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