Director, Medical Writing

Location: Remote, United States; Wilmington, Delaware

Company

hirify.global is a global biopharmaceutical company developing proprietary therapeutics in Hematology, Oncology, Inflammation, and Autoimmunity.

What you will do

• Develop clinical and regulatory documents, including Investigator Brochures, Clinical Study Reports, and marketing authorization submission documents.
• Lead and coordinate internal and external medical writing activities for assigned programs and compounds.
• Ensure documents present accurate, consistent, data-driven clinical messages in line with program goals, ICH guidelines, and global regulatory requirements.
• Partner with cross-functional teams on deliverables, timelines, process improvements, and issue resolution.
• Oversee contract medical writing resources, including scopes of work and project completion.
• Mentor and manage medical writers where applicable and contribute to the Medical Writing Leadership Team.

Requirements

• Bachelor’s degree required; an advanced degree in a relevant scientific, clinical, or regulatory field is preferred.
• More than 10 years of medical writing experience in the biopharmaceutical or CRO industry.
• Ability to understand and interpret clinical and scientific data and define appropriate data presentation.
• Strong project management, communication, collaboration, and problem-solving skills.
• Proficient knowledge of global regulatory requirements and clinical development timelines.
• Proficiency in MS Word and working knowledge of electronic document management systems and document templates.

Nice to have

• Prior people management experience.
• Knowledge of therapeutic areas across all phases of clinical development.

Culture & Benefits

• Work with cross-functional teams on global regulatory submissions.
• Opportunity to contribute to medical writing strategy and process improvement.
• Support for mentoring and professional development of medical writing staff.
• Work within a diverse and equal-opportunity environment.