We are seeking an experienced medical writer to lead authoring and development of high complexity clinical regulatory documents. This is a challenging opportunity for a highly skilled professional with expertise in writing and leading development of clinical study protocols, reports, investigator brochures, and other complex documents.
The ideal candidate will have advanced degree (PhD or Master's) and minimum 6 years eCTD submission writing experience, including 3 years as medical writing project lead. They must be able to manage multiple stakeholders and projects, drive consensus and facilitate decision-making to propel the document development cycle forward.
This role requires excellent communication skills, collaboration/teamwork, and adaptability across environments and therapeutic areas. The successful candidate will be comfortable leading team discussions, managing complex medical writing tasks and processes, engaging with a variety of stakeholders, and confidently contributing their expertise based on experience.
At our organization, you will have the opportunity to work on high-profile projects, collaborate with talented professionals, and shape your own career path. If you thrive in medical writing and want to remain deeply involved in science, this is an exciting opportunity to join our team.
* You will serve as an expert contributor on project teams, using your expertise to write, advise, and coordinate development of complex clinical regulatory documents.
* You will leverage your experience to manage writing projects, coordinate and collaborate with stakeholders, steer discussion, drive consensus and facilitate decision-making.
We offer comprehensive training and support to prepare you for leadership roles, so whether you are coming from management or just starting out, we have opportunities for growth and development.