Lead Medical Communications Specialist

1 month ago

Toronto, Ontario, Canada ThermoFisher Scientific Full time
Position Overview
As a Lead Medical Communications Specialist at Thermo Fisher Scientific, you will engage in impactful work that contributes positively on a global scale.

Work Environment
This role is designed to be remote, allowing flexibility in your work location across North America.

Key Responsibilities
- Serve as the primary author for clients in the Functional Service Provider (FSP) sector, producing high-quality medical and scientific documentation.
- Develop and coordinate essential documents such as clinical study reports and study protocols, ensuring clarity and precision in summarizing clinical study data.
- 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 and provide constructive feedback on documents prepared by junior team members.
- Offer training and mentorship to junior writers and program managers on document preparation, regulatory requirements, and therapeutic area knowledge.
- Ensure adherence to quality processes and compliance for all assigned documents.
- Contribute to the development of best practices and methodologies to achieve optimal results, including client-specific processes.
- Participate in project launch meetings, review sessions, and team discussions.

Qualifications
- A Bachelor’s degree in a scientific discipline or equivalent relevant qualifications.
- A minimum of 5 years of regulatory writing experience, demonstrating the necessary skills and knowledge for the role.
- Additional qualifications in medical writing (e.g., AMWA) are preferred; however, a combination of education, training, and relevant experience may be considered.
- Exceptional data interpretation and medical writing skills, including proficiency in grammar, editing, and proofreading.
- In-depth expertise in a specialized area such as preclinical research, therapeutic areas, or regulatory submissions.
- Strong computer skills, including proficiency with client templates and software such as Excel and Outlook.

Company Culture
At Thermo Fisher Scientific, we prioritize the growth and development of our employees. Our award-winning learning and development programs are designed to help you reach your full potential. We foster a flexible working culture that values work-life balance, ensuring that our global organization maintains a local feel.

As part of a diverse team of over 100,000 colleagues, we share core values of Integrity, Intensity, Innovation, and Involvement, working collaboratively to advance research, tackle complex scientific challenges, drive technological advancements, and support patients in need.

Thermo Fisher Scientific is an Equal Employment Opportunity/Affirmative Action Employer, committed to diversity and inclusion in the workplace.

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