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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.
As a Senior Medical Writer within the Early Development team, you will provide high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients.
Essential Functions:
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 (Phase 1, 1b and 2a)
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 client specific processes.
May assist in program management activities. Identifies and resolves out-of scope activities. Duties could include developing timelines, budgets, forecasts and contract modifications.
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 5+ years).
Experience working in the pharmaceutical/CRO industry preferred.
Additional qualifications in medical writing (AMWA; EMWA; RAC) is advantageous.
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).
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. Watch as our colleagues explain five 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.
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.