Director / Senior Director, Medical Writing

About Us

About the Role

As the Senior Director, Medical Writing, you will lead the function and play a hands-on role in shaping the communication, development, and delivery of clinical and scientific data to regulatory agencies, healthcare professionals, and other stakeholders.

Reporting to the SVP, Regulatory affairs, this position requires a highly motivated and enthusiastic professional with expertise throughout the product lifecycle. Key success factors for the position include proven track record in overseeing Medical Writing teams and external vendors, and the delivery of high-quality documents (eg, protocols, IBs, CSRs, module 2 summary documents) and publications (abstracts, presentations, journal articles).

This is an exciting opportunity to join a clinical-stage company and build the function while contributing to many milestones as we continue to evolve. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.

Key Responsibilities

• Independently author and manage others in creation of clear and concise, submission-ready clinical and regulatory documents
• Lead writing strategy, drive document content and organization, establish and manage timelines, and ensure adherence to regulations and guidelines
• Oversee document review and comment resolution process
• Participate in Rapid Response Teams to support timely delivery of responses to Health Authority Information Requests
• Generate and maintain templates, style guides, and quality control checklists that drive consistency
• Plan strategically, anticipate problems, and recommend process improvements to address current and future needs
• Develop budget and resource strategies to ensure on schedule completion of medical writing deliverables using a mix of internal and external medical writers
• Serve on cross-functional teams working on SOPs, process improvements, and integration of new tools and technologies
• Coach, develop, and support writers (internal and external)
• Act as subject matter expert for development of data transparency deliverables
• Oversee medical writing resourcing to support publication plans and ensure consistency of messaging with clinical and regulatory submissions
• Ability to travel 10-15% for functional team meetings and company events

Experience

• Advanced degree in life sciences preferred; minimum BS/BA required
• 12+ years’ experience in a medical writing capacity within drug development
• Working knowledge of clinical research, study design, pharmacology, biostatistics, regulatory requirements, and medical terminology
• Experience leading medical writing teams responsible for global marketing authorization applications
• Exceptional information gathering and conceptual skills
• Ability to analyze, interpret, and summarize highly complex data
• Outstanding project management and organizational skills
• Adept at facilitating the open exchange of ideas and opinions to achieve consensus
• Ability to work effectively under pressure and meet time-sensitive deadlines
• Demonstrated experience mentoring medical writers, managing project work, and supervising internal and external writers
• Proficient in the use of MS Word, Endnote, Adobe Acrobat, PleaseReview, and structured document templates
• Experience with inspection readiness activities and representing MW during GCP inspections
• Proactive team player, collaborative, resourceful, and flexible