Director, Medical Writing

Role Summary

Director, Medical Writing will oversee the delivery of high quality clinical and regulatory documents across investigational and marketed products. The role requires proactive leadership, coordinating cross-functional teams to produce on-time, on-target documents. The position requires a strong understanding of drug development, clinical research concepts and data interpretation, and may involve overseeing external vendors and internal resources, as well as developing processes to ensure compliant medical writing services.

Responsibilities

• Independently author and oversee external/internal resources on the authorship of eSubmission ready clinical and regulatory documents in accordance with applicable guidelines, regulations, practices, and procedures. Documents include, but are not limited to, clinical study reports, investigator’s brochures, Module 2 summaries of registration dossiers, and clinical study protocols.
• Represent Medical Writing and provide medical writing expertise on cross-functional teams
• Serve as a subject matter expert, advising and collaborating with cross-functional stakeholders on document strategy, authoring and review processes, and best practices
• Develop detailed timelines for document development in line with company goals and SOPs
• Manage multiple rounds of team review through document finalization (ie, distribute documents for review; consolidate and resolve of reviewer comments; lead efficient cross-functional review roundtables)
• Ensure the accuracy, consistency, and quality of documents. Coordinate a formal quality control review of documents, as applicable
• Coordinate with the Regulatory Operations team to publish documents that meet eSubmission ready standards
• Collaborate with Biostatistics to review statistical analysis plans to ensure that the outputs planned meet data reporting needs and document templates
• Collaborate with Clinical Development to review protocols and amendments to ensure that the documents are clear, well written, and consistent with the template, internal and external guidance, and program-specific conventions.
• Collaborate effectively across Viridian and with Viridian partner companies and external vendors, as applicable
• Participate in the development of department SOPs and process-related tools to improve and enhance operations and to ensure compliance with regulatory standards and ICH/GCP/eCTD guidelines
• Participate in the ongoing development of processes, initiatives, and tools to improve and enhance operations and to ensure compliance with regulatory standards and ICH/GCP/eCTD guidelines
• Participate in the selection of external vendors, from the initial preparation and review of completed Requests for Proposals through to contract negotiation and finalization
• Participate in the management of ongoing operations of high performing external vendors
• Participate in the maintenance of a long-term project forecast and resource plan to deliver all the documents required to advance company goals
• Support medical writing and other cross-functional colleagues as necessary (eg, document review, format, and QC)

Qualifications

• BA/BS and 8+ years of medical writing experience in the pharmaceutical or biotech industry; advanced degree preferred
• Experience with a broad range of clinical regulatory documents spanning the drug development lifecycle
• Strong understanding of the drug development process, including 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; excellent attention to detail
• Success in managing resources (internal, external, or hybrid)
• Strong ability to understand and interpret medical and scientific data
• Proficient in Microsoft Word, PowerPoint, Excel, Project, and SharePoint
• Experience with automated document templates and Adobe Acrobat and EndNote
• Excellent communication, interpersonal, and organizational skills
• Experience working on cross-functional teams
• Able to prioritize tasks, work simultaneously on multiple projects
• Strong commitment to ethical standards
• Proven mindset of proactive continuous improvement
• Ability to travel up to 15%