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FSP Principal Medical Writer

ThermoFisher Scientific • Wilmington, NC • 5d ago

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 FSP Team in North America! This would be a remote role working from any location in NA. We are looking for as Associate Medical Writing Director to be dedicated to a client in the FSP space; experience in Oncology and in leading submissions would be valuable. As an Associate Medical Writing Director you will leads multiple large, complex, strategic client programs with high visibility among internal and client teams, often requiring a high degree of client engagement and management. As the lead writer, you will review documents for the team and provide training and guidance to junior team members. As a subject matter expert you will provide advice on document development strategy, regulations, and industry best practices. You will collaborate with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.

Essential Functions:

Serves as the medical writing oversight director, project manager, lead medical writer, or senior reviewer on large projects and/or development programs

Writes complex documents, provide senior review, and serves as backup program manager. Duties could include researching, writing and editing study reports and protocols, summarizing data from clinical studies, writing or providing input on complex regulatory and scientific documents, publications, and medical information deliverables, and providing senior review of project materials.

Oversees the work of medical writers and program managers on the same program and provides training and mentorship for writers and program managers on processes, best practices and technical aspects of program management.

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.

Partners with business development and senior management in securing new business up to and including franchises by making presentations to clients, and leading development and review proposal texts and budgets, and supporting contract negotiations.

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 12+ years).

Experience in managing and directing complex medical writing projects required

Experience working in the pharmaceutical/CRO industry preferred

Submissions document experience advantageous

Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous

Knowledge, Skills, and Abilities:

Expert knowledge of global, regional, national, and other document development guidelines

Expert 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

Professional negotiation skills

Excellent judgment; high degree of independence in decision making and problem solving

Capable of mentoring 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 (https://www.ppdi.com/careers/about#Training) , 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 (https://www.ppdi.com/careers/life-at-ppd) , 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.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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