Senior Director, Medical Writing

Zenas BioPharma•Waltham, MA

4h•$219,400 - $274,300•Hybrid

About The Position

The Senior Director, Medical Writing (MW) will be responsible for writing or providing direction and leadership to other writers to ensure the timely delivery of high-quality documents that are scientifically rigorous, logically organized, and have accurate data presentation and interpretation, in accordance with program goals and regulatory requirements. We seek a highly qualified individual for this role with the demonstrated ability to independently lead the pertinent sections of a marketing authorization submission including the development, review, and approval of clinical documents and the ability to identify any new or unique document types that may require a different approach. This position will partner closely with and report to the Executive Director, Medical Writing.

Requirements

Bachelor’s degree in a scientific discipline or equivalent combination of education and experience.
12+ years of medical writing capacity or equivalent, in pharma/biopharma/contract research organization (CRO).
Extensive knowledge of English grammar and American Medical Association (AMA) style guide.
Prior direct experience leading medical writing team(s) or members, either internal, contract writers or combination, responsible for global marketing authorization applications.
Expert knowledge of drug development, clinical research, study design, biostatistics, regulatory requirements, and medical terminology.
Proficiency in use of Microsoft Office applications (Word, Outlook, Excel, PowerPoint), Adobe Acrobat, electronic document management systems, document templates, project management tools, and reference management tools.
Comfortable working hands-on while also building scalable infrastructure for future growth.
Ability to travel to and work from the Zenas headquarters every three months or as needed (up to 15%).

Nice To Haves

A Master's degree in a scientific area is preferable.

Responsibilities

Providing leadership across the medical writing function through strategic input, continual process improvement, and innovation in the development and implementation of a strategic view of regulatory documents.
While partnering with the Executive Director, Medical Writing, ensures medical writing deliverables are resourced, escalates critical issues, and ensures sound strategic direction of the clinical documents for submission to regulatory authorities.
May have direct people management responsibility of writers, including providing oversight of medical writing vendors and contractors. Will provide mentoring and providing guidance on prioritization, content, timeline development, and process management.
Assist the Executive Director, Medical Writing, partnering with legal and finance as needed, to negotiate medical writing contracts and develop budgets for contract medical writing resources.
May participate in the selection of and will oversee the operation of external vendors and contractors, including resource requirements forecasting, contract change management, and oversight of vendor financials.
Oversee contract medical writing resources as required to ensure timely completion of assigned projects, which may include defining and reviewing of scopes of work within the assigned programs.
Oversight of clinical trial transparency documents and vendor oversight.
Collaborate with MW organization to maintain functional SOPs, best working practices guidelines, document templates, style guides, reference library, and quality control checklists that drive consistency across documents and processes.
Contributes to a supportive team culture that promotes open-minded thinking and collaboration by leading through example.
Demonstrated ability to pivot strategy quickly when needed to meet organizational needs, working effectively in a fast-paced, collaborative, start-up culture.