Executive Director, Medical Writing Remote (anywhere in United States)

The Company is seeking an Executive Director for Medical Writing to provide strategic leadership in the planning, development, and delivery of high-quality clinical and regulatory documents. The successful candidate will be a key partner to various functions, including clinical development, regulatory affairs, biostatistics, clinical operations, quality assurance, and pharmacovigilance. This role is pivotal in driving operational excellence, ensuring the accuracy and compliance of scientific and regulatory documentation, and supporting global development and registration strategies. The Executive Director will also be responsible for leading a high-performing medical writing organization, fostering a culture of scientific excellence, and overseeing external medical writing resources. Applicants must have an advanced scientific degree and a minimum of 15 years' experience in medical writing within the pharmaceutical, biotechnology, or CRO industry, with a strong background in leading medical writing teams. The role requires a proven track record in preparing and delivering major regulatory submissions, extensive experience in authoring clinical and regulatory documents, and a strong understanding of global regulatory requirements. The ideal candidate will have a background in oncology drug development, experience in managing both internal teams and external vendors, and a demonstrated ability to drive process improvements and innovation in medical writing. The Executive Director will be expected to influence decision-making, resolve complex issues, and champion the adoption of best practices and new technologies in the field.

Hiring Company

Celcuity