Sr Director, Medical Writing - Publications

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

The Senior Director, Medical Writing-Publications will provide strategic direction within the department and lead the successful development and tactical execution of publication plans across multiple programs in alignment with integrated evidence generation plans and lifecycle strategies and in compliance with SOPs, publication guidelines, and company goals. In addition, the Senior Director will be responsible for writing and coordinating the writing of peer-reviewed scientific publications, including distribution of work to medical writers or agencies as needed. They will serve as the primary contact for publication activities in collaboration with a cross‐functional group, including Clinical Development, Medical Affairs, Biometrics, Pharm/Tox, Research, and other relevant functions.  

Work Model: 

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

1. Lead key strategic initiatives within the department including publication strategy, planning, and execution of Ultragenyx products and pipeline publication plans, ensuring alignment with department and company goals. 
2. Provide leadership within the department by proposing and overseeing new initiatives and capabilities, such as establishing best practices for pubs strategy development and pull-through. 
3. Interact with external authors and key internal stakeholders to develop high-quality publications (manuscripts, abstracts, posters, slide presentations) for peer-reviewed journals and scientific congresses and provide publication support and ensure compliant development of company-sponsored publications. 
4. Ensure smooth and effective document management from start to finish (i.e., generation of a blank document to a final approved version), which may include, but is not limited to: first draft authoring, reference retrieval, generating bibliographies, editing (e.g., follow house style guide), and managing various processes (e.g., reviews, QC, QA, formatting, publishing, document archiving, journal and congress submissions).  
5. Liaise with relevant corporate functions and partner(s), as applicable, to ensure appropriate communication of publications‐related activities including manuscripts and congress abstracts/posters/presentations. 
6. Uses advanced communication and persuasion strategies to negotiate on behalf of their department or function on strategic matters. 
7. Contributes to strategic planning for the broader function and support high‐quality execution of Corporate‐wide initiatives. 
8. Acts as a trusted advisor and recognized technical expert. 
9. Manage and/or mentor junior medical writers and contractors. 
10. Support publication budget planning and management. 

Requirements:

1. BS, MS, or doctorate in a scientific or medical field. 
2. Solid experience (BS with >15 years or advanced degree with >10 years) in publication management and medical writing in the biotechnology/pharmaceutical industry preferred. 
3. Proven success with leading and managing medical writing agencies as well as track record for consistently meeting or exceeding quantitative targets. 
4. Demonstrated experience analyzing and communicating scientific data in peer-reviewed scientific publications; knowledge of applicable publications-related guidelines (i.e., ICMJE, GPP) and best practices, as well as legal, regulatory, compliance, and clinical/medical affairs. 
5. Experience writing and preparing manuscripts for publication in peer‐reviewed journals as well as abstracts, posters, and slide decks for presentation at scientific congresses. 
6. Successful and superior influencing skills across all levels of the organization and external collaborators. 
7. Exceptional oral and written communication skills. 
8. Experience in successfully engaging with cross‐functional product teams. 
9. Strong organizational abilities and experience in a multitasking environment. 
10. Motivated, self‐directed, and able to work autonomously and in team settings to meet aggressive organizational goals. 
11. Rare disease experience and a strong understanding of neurodevelopmental disorders are a plus. 

#LI-CS1 #LI-Hybrid, or #LI-Remote