Senior Director, Medical Writing

Zenas BioPharmaWaltham, Massachusetts, United States · Posted 22 days ago

Full-timeEst. 246,850 USD

Description

Zenas is a clinical-stage global biopharmaceutical company committed to becoming a leader in the development and commercialization of transformative therapies for patients with autoimmune diseases. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients living with autoimmune diseases. Zenas is advancing two late-stage, potential franchise molecules, obexelimab and orelabrutinib. Obexelimab, Zenas’ lead product candidate, is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. We believe that obexelimab’s unique mechanism of action and self-administered, subcutaneous injection regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease. Orelabrutinib is a potentially best-in-class, highly selective CNS-penetrant, oral, small molecule Bruton’s Tyrosine Kinase (BTK) inhibitor with the potential to address compartmentalized inflammation and disease progression in Multiple Sclerosis (MS). Zenas’ earlier stage programs include ZB021, a clinical-stage, potentially best-in-class, oral, IL-17AA/AF inhibitor; ZB022, a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor; and ZB014, a preclinical half-life extended anti-CD-19 and FcγRIIb monoclonal antibody.

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 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.

Key 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.

Qualifications:

Bachelor’s degree in a scientific discipline or equivalent combination of education and experience. A Master's degree in a scientific area is preferable.
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%).

#LI-Hybrid

Zenas is committed to fair and equitable compensation practices. The base salary pay range for this role is $219,400 to $274,300. 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.