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!

Position Summary

The Senior/Executive Director, Medical Writing (MW) will be responsible for establishing the function and play a 'hands-on' role in shaping the communication, the development, and the delivery of clinical and scientific data to regulatory agencies, healthcare professionals, and other stakeholders. This role involves developing and maintaining 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 overseeing Medical Writing teams, external vendors, and the delivery of high-quality submission-ready documents (eg, INDs, filings, protocols, IBs, CSRs, etc.) and publications (abstracts, presentations, journal articles). This position will report to the Vice President, Head of Global Regulatory Affairs.

Key Responsibilities

* As the Senior/Executive Director, Medical Writing, you will establish the function and oversee external medical writing resourcing to support publication plans and ensure consistency of messaging with clinical and regulatory submissions

* Lead writing strategy, drive document content and organization, develop and manage timelines, and identify relevant stakeholders

* Develop and maintain 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 manage others in creation of clear and concise, submission-ready clinical and regulatory documents

* Develop budget and resource strategies to ensure on schedule completion of medical writing deliverables

* Coach, develop, and support writers (external)

* 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.

Qualifications

* Bachelor's degree in a scientific discipline or systems technology or equivalent combination of education and experience.

* 10 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 mentoring medical writers, managing project work, and supervising 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 $207,200 to $291,000. 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.

Zenas BioPharma is proud to be an equal opportunity employer. We are committed to fostering an environment where diversity is valued. All qualified applicants will receive consideration for employment based on merit, qualifications and the needs of the business.