Senior Manager, Medical Writer
Spyre Therapeutics
Job Level
Lead
About the role
- Developing and authoring clinical and regulatory documents, including clinical study reports, protocols, investigator brochures, and regulatory submissions. Ensuring all documents comply with regulatory guidelines and company standards for quality and accuracy. Collaborating with cross-functional teams, including clinical operations, biostatistics, and regulatory affairs, to gather and interpret clinical data. Mentoring and guiding junior medical writers, fostering a culture of excellence and continuous improvement. Reviewing and editing documents prepared by other writers to ensure consistency and adherence to regulatory requirements. Staying current with industry trends and regulatory changes to integrate best practices into medical writing processes. Contributing to the development of templates, style guides, and standard operating procedures to enhance the efficiency and quality of medical writing activities.
Requirements
- Extensive experience in medical writing, with a proven track record of developing clinical and regulatory documents in the pharmaceutical or biotech industry. Strong proficiency in scientific writing and editing, with excellent attention to detail. Excellent analytical and problem-solving skills, with the ability to interpret complex clinical data and present it clearly. Demonstrated leadership skills, with experience in managing and mentoring teams effectively. Exceptional communication skills, with the ability to convey technical concepts to diverse audiences. Detail-oriented, with strong organizational skills to manage multiple projects and deadlines in a dynamic environment.
