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Lead Medical Writer
hace 3 meses
Principal Medical Writer (EMEA) (FSP; Remote)
At Thermo Fisher Scientific, you will engage in impactful work that contributes positively on a global scale. Our mission is to empower our clients to enhance health, safety, and cleanliness worldwide. We equip our teams with the necessary resources to fulfill their career aspirations while advancing scientific endeavors through the research, development, and delivery of transformative therapies. With clinical trials executed in over 100 countries and the continuous evolution of innovative frameworks for clinical research through our PPD clinical research portfolio, our efforts encompass laboratory, digital, and decentralized clinical trial services. Your commitment to ensuring quality and precision will significantly influence health outcomes that communities rely on today and in the future.
Key Responsibilities:
Acts as the primary author for FSP clients, producing and contributing to essential documents such as clinical study reports and study protocols, while summarizing data from clinical trials. May conduct research, compose, or refine intricate clinical and scientific documents, including Investigator Brochures (IBs), Investigational New Drug applications (INDs), and Marketing Authorization Applications (MAAs). Reviews documents prepared by junior team members and may offer training and mentorship on document preparation, software utilization for document development, regulatory requirements, and therapeutic area knowledge. Ensures adherence to quality standards and requirements for assigned documents, providing insights and independently developing best practices and methodologies for optimal outcomes, including various client-specific processes. May assist in program management tasks, identifying and addressing out-of-scope activities, which may involve developing timelines, budgets, forecasts, and contract modifications. Represents the department in project launch meetings, review sessions, and project team discussions.Qualifications:
A Bachelor’s degree in a scientific field or equivalent relevant academic/vocational qualification; an advanced degree is preferred.
Prior experience that equips the individual with the knowledge, skills, and abilities to perform the role (approximately 5+ years).
Experience in the pharmaceutical or CRO industry is preferred.
Familiarity with FSPs is advantageous.
Additional qualifications in medical writing (AMWA; EMWA; RAC) are beneficial.
In certain instances, a combination of appropriate education, training, and/or directly related experience may be deemed sufficient for an individual to meet the role's requirements.
Skills and Competencies:
Exceptional data interpretation and medical writing capabilities, including grammatical, editorial, and proofreading skills. Strong project management abilities. Excellent interpersonal skills, including problem-solving capabilities. Proficient negotiation skills. Outstanding oral and written communication skills, with strong presentation abilities. Comprehensive knowledge of global, regional, national, and other document development guidelines. In-depth expertise in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc. Sound judgment and decision-making skills. Proficient computer skills and adept with client templates; good knowledge of document management systems and other relevant applications (e.g., Excel, Outlook).What We Provide:
At PPD clinical research services, we prioritize hiring the best talent, fostering personal and professional development, and recognizing the strength of teamwork. We understand the importance of career growth and provide opportunities to ensure you reach your full potential.
In addition to a competitive salary, we offer a comprehensive benefits package focused on the health and well-being of our employees. We promote a work-life balance and have cultivated a collaborative environment where colleagues are eager to share expertise and enjoy working together. As a global organization, we maintain a local feel.
Our mission is to empower our clients to enhance health, safety, and cleanliness worldwide. As a unified team of over 100,000 colleagues, we share core values of Integrity, Intensity, Innovation, and Involvement, working collaboratively to accelerate research, tackle complex scientific challenges, drive technological advancements, and support patients in need.
