At Thermo Fisher Scientific, you'll 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. Demonstrates subject matter and therapeutic area expertise.
May assist program manager. Collaborates with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.
Essential Functions and Other Job Information:
• Serves as primary author who writes and provides input on routine documents
such as clinical study reports and study protocols, and summarizes data from
clinical studies.
• May research, write or edit complex clinical and scientific and program level
documents, including IBs, INDs, and MAAs.
• Reviews routine documents prepared by junior team members. May provide
training and mentorship for junior 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. Provides input on and independently develops best practices,
methods and techniques for achieving optimal results, including various clientspecific processes.
• May assist in program management activities. Identifies and resolves out-ofscope activities. Duties could include developing timelines, budgets, forecasts
and contract modifications.
• Represents the department at project launch meetings, review meetings, and
project team meetings.
Qualifications:
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 5+ years).
Experience working in the pharmaceutical/CRO industry 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, therapeutic, regulatory submissions, communications, 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)
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. 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.
Apply today! 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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