Position Summary:

The Director, Medical Writing (MW) will be responsible for assigned programs and projects which may include the development, and the delivery of clinical and scientific data to regulatory agencies, healthcare professionals, and other stakeholders.  This role also involves contribution to the development and maintenance of standard operating procedures (SOPs), style guides, and quality control checklists that drive consistency across documents and processes. We seek a highly qualified individual for this role that includes a proven track record in Medical Writing working directly with project teams and external vendors to deliver high-quality submission-ready documents (eg, INDs, filings, protocols, IBs, CSRs, etc.) and publications (abstracts, presentations, journal articles). This position will report to the Executive Director, Medical Writing.

Key Responsibilities:

• Lead writing strategy, drive document content and organization, develop and manage timelines, and identify relevant stakeholders for assigned programs/projects
• Collaborate with MW organization to establish functional SOPs, style guides, and quality control checklists that drive consistency across documents and processes
• Advise on document development, ensuring adherence to regulations, ICH guidelines, and SOPs.
• Independently author and provide guidance to team members in the creation of clear and concise, submission-ready clinical and regulatory documents
• Act as subject matter expert for development of data transparency deliverables
• Plan strategically, anticipate problems, and recommend process improvements to address current and future needs
• Perform other medical writing related duties as assigned
• Contributes to a supportive team culture that promotes open-minded thinking and collaboration by leading through example
• Ability to change direction quickly or pivot strategy when needed

Qualifications:

• Bachelor’s degree in a scientific discipline or systems technology or equivalent combination of education and experience.
• 7 + years of medical writing capacity in pharma/biopharma/contract research organization (CRO).
• Extensive knowledge of English grammar and American Medical Association (AMA) style guide.
• Demonstrated experience directly leading clinical and regulatory document development, managing project work, and working collaboratively with both internal and external writers/vendors.
• Demonstrated track record of contribution to successful regulatory components used in filings e.g., IND/CTAs, NDA/BLA/MAAs.
• Working knowledge of biologics drug development, clinical research, study design, biostatistics, regulatory, and medical terminology.
• Computer proficiency in Microsoft Office (including Word, Excel, PowerPoint, and Project Management tools) with some experience with Veeva Vault products and MW artificial intelligence (AI) software/writing tools would be a g plus.
• Ability to work effectively in a fast-paced, collaborative, start-up culture with evolving processes.
• Demonstrates flexibility to work non-traditional work hours when needed, given international operations across time zones.

#LI-Hybrid

Zenas is committed to fair and equitable compensation practices. The base salary pay range for this role is $178,400 to $223,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.

Zenas believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Zenas’ competitive total rewards strategy that also includes annual performance bonus, equity, full range of benefits and other incentive compensation plans.