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Lead Medical Writer for Clinical Research
hace 3 meses
Position: Senior Medical Writer (EMEA) (FSP; Remote)
At Thermo Fisher Scientific, we are committed to impactful work that contributes positively on a global scale. Our mission is to empower our clients to enhance health, safety, and environmental standards. We equip our teams with the necessary resources to achieve their career aspirations while advancing scientific endeavors through research, development, and the delivery of transformative therapies. Our clinical trials are conducted across over 100 countries, and we are continually innovating frameworks for clinical research through our PPD clinical research portfolio, encompassing laboratory, digital, and decentralized clinical trial services. Your commitment to quality and precision will significantly influence health outcomes for individuals and communities now and in the future.
Role Overview:
We are eager to grow our Medical Writing FSP Team in EMEA. This position offers the flexibility of remote work from any location within EMEA. We seek a Senior Medical Writer dedicated to a client in the FSP sector; experience in Immunology, Oncology, or Vaccines is advantageous but not mandatory. As a Senior Medical Writer in the FSP team, you will be responsible for producing high-quality medical and scientific documentation from the planning phase through to the delivery of final drafts to both internal and external stakeholders. You will collaborate with various clients, facilitating effective communication that leads to operational excellence.
Key Responsibilities:
- Act as the primary author for FSP clients, drafting and providing input on essential documents such as clinical study reports and study protocols, while summarizing data from clinical studies.
- Conduct research, write, or edit complex clinical and scientific documents, including Investigator Brochures (IBs), Investigational New Drug applications (INDs), and Marketing Authorization Applications (MAAs).
- Review documents prepared by junior team members and offer training and mentorship on document preparation, software utilization, regulatory requirements, and therapeutic area knowledge.
- Ensure adherence to quality processes and requirements for assigned documents, contributing to the development of best practices and methods for optimal outcomes.
- Support program management activities, identifying and addressing out-of-scope tasks, which may include developing timelines, budgets, forecasts, and contract modifications.
- Represent the department in project launch meetings, review sessions, and project team discussions.
Qualifications:
A Bachelor's degree in a scientific discipline or equivalent relevant qualification is required; an advanced degree is preferred.
Prior experience that equips you with the knowledge, skills, and abilities to perform this role (approximately 5+ years) is essential.
Experience in the pharmaceutical or CRO industry is preferred, along with familiarity with FSPs.
Additional qualifications in medical writing (AMWA; EMWA; RAC) are advantageous.
In certain cases, a combination of appropriate education, training, and/or directly related experience may be deemed sufficient to meet the role's requirements.
Skills and Competencies:
- Exceptional data interpretation and medical writing abilities, including grammatical, editorial, and proofreading skills.
- Strong project management capabilities.
- Excellent interpersonal skills, including problem-solving and negotiation.
- Outstanding oral and written communication skills, complemented by 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, or regulatory submissions.
- Sound judgment and decision-making skills.
- Proficient computer skills, including familiarity with client templates and document management systems (e.g., Excel, Outlook).
What We Offer:
At PPD clinical research services, we prioritize hiring top talent, fostering personal and professional development, and recognizing the strength of teamwork. We understand the importance of your growth throughout your career, and at PPD clinical research services, you will benefit from a supportive environment that helps you reach your potential.
In addition to a competitive salary, we provide a comprehensive benefits package focused on the health and well-being of our employees. We value a work-life balance and have cultivated a collaborative atmosphere where colleagues are eager to share their expertise and enjoy working together. Although we are a global organization, we maintain a local feel.
Our mission is to empower our clients to create a healthier, cleaner, and safer world. As one team of over 100,000 colleagues, we uphold a shared set of values - Integrity, Intensity, Innovation, and Involvement - working collectively to accelerate research, tackle complex scientific challenges, drive technological advancements, and support patients in need.
