Principal Medical Writer

Thermo Fisher Scientific • TX

87d

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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.

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.
• Develops and reviews best practices, methods and techniques for achieving optimal results, including various client-specific processes, and leads process improvement initiatives.
• May serve as backup program manager.
• Identifies and resolves out-of-scope activities.
• Develops timelines, budgets, forecasts and contract modifications.
• Assists business development with client presentations and proposal text review.
• Attends bid defense meetings and capabilities presentations.
• Represents the department at project launch meetings, review meetings, and project team meetings.

Benefits

• Competitive salary.
• Extensive benefits package based around the health and well-being of employees.
• Flexible working culture.
• Work-life balance.
• Award-winning learning and development programme.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees