Director, Medical Writing

$178,400 - $223,000/Yr

Zenas BioPharma - Waltham, MA

Full-time - Mid Level

Hybrid - Waltham, MA

Professional, Scientific, and Technical Services

About the position

Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients around the world. With clinical development and operations globally, Zenas is advancing a deep and balanced global portfolio of potential first- and best-in-class autoimmune therapeutics in areas of high unmet medical need while meeting the value requirements of the dynamic global healthcare environment. The company's pipeline continues to grow through our successful business development strategy. Our experienced leadership team and network of business partners drive operational excellence to deliver potentially transformative therapies to improve the lives of those living with autoimmune and rare diseases. We are seeking top talent who share our commitment to patients and have a track record of success in acquiring, developing and commercializing products across the globe. Our colleagues have an opportunity to engage in a fast-paced learning environment and experience individual and organizational success as we work towards becoming a global immunology and autoimmune disease leader, while living our values of Transparency, Relationships, Urgency, Excellence and Innovation - TRUE Innovation!

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

Requirements

• 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

Benefits

• Annual performance bonus
• Equity
• Full range of benefits
• Other incentive compensation plans