Senior Director, Medical Writing

Role Summary

Senior Director, Medical Writing responsible for delivering high-quality clinical and regulatory documents across investigational and marketed products, leading external vendor management, developing processes to ensure compliant, efficient medical writing services, and collaborating with cross-functional teams to meet program goals.

Responsibilities

• Maintain a long-term project forecast and resource plan to deliver all documents required to advance company goals.
• Manage the selection of external vendors, from RFPs through contract negotiation and finalization.
• Independently author and manage others in creation of clear, submission-ready clinical and regulatory documents.
• Oversee ongoing operations of external vendors, including resource forecasting, contract changes, and vendor financial oversight.
• Develop and enhance processes, tools, and initiatives to ensure regulatory compliance (ICH/GCP/eCTD) and efficient operations.
• Serve as a subject matter expert, advising cross-functional stakeholders on document strategy and best practices.
• Represent Medical Writing on cross-functional teams for marketed and/or investigational products.
• Develop detailed timelines for document development aligned with company goals and SOPs.
• Write clinical and regulatory documents (e.g., protocols, clinical study reports, Investigator’s Brochures, Module 2 summaries).
• Manage multiple rounds of team review, consolidate reviewer comments, and lead cross-functional review roundtables.
• Ensure document accuracy, consistency, and quality; coordinate formal QC reviews as applicable.
• Coordinate with Regulatory Operations to publish eSubmission-ready documents.
• Collaborate with Data Sciences to review statistical analysis plans to ensure outputs meet data reporting needs.
• Lead preparation of public disclosures of study results on registries (e.g., ClinicalTrials.gov, CTIS), coordinating posting, QC, redaction, and stakeholder notification.
• Collaborate across Ironwood and with partner companies and external vendors.
• Participate in development of department SOPs and process tools to improve operations and ensure regulatory compliance.
• Support medical writing and cross-functional colleagues with document review, formatting, and QC as needed.

Qualifications

• BA/BS and 12+ years of medical writing experience in the pharmaceutical or biotech industry; advanced degree preferred
• Success in managing resources (internal, external, or hybrid)
• Direct experience leading medical writing teams responsible for global marketing authorization applications
• Experience with a broad range of clinical regulatory documents spanning the drug development lifecycle
• Strong understanding of the drug development process, regulatory requirements, and ICH/GCP/eCTD guidelines
• Working knowledge of drug development, clinical research, study design, biostatistics, regulatory, and medical terminology
• Excellent technical writing and editorial skills; strong attention to detail
• Ability to understand and interpret medical and scientific data
• Proficient in Microsoft Word, PowerPoint, Excel, Project, and SharePoint
• Experience with automated document templates (e.g., StartingPoint), Adobe Acrobat, and EndNote
• Excellent communication, interpersonal, and organizational skills
• Experience working on cross-functional teams
• Well organized; able to prioritize tasks and manage multiple projects to tight timelines

Education

• Not specified beyond the requirement for BA/BS; advanced degree preferred