Offer summary

Qualifications:

Advanced degree in life sciences preferred; minimum BS/BA required., 12+ years of experience in medical writing within drug development., Proven track record in leading medical writing teams and managing external vendors., Strong project management, organizational skills, and ability to work under pressure..

Key responsabilities:

Independently author and manage the creation of clinical and regulatory documents.

Lead writing strategy, manage timelines, and ensure adherence to regulations.

Oversee document review processes and participate in Rapid Response Teams for Health Authority requests.

Coach and develop internal and external medical writers while ensuring consistency in messaging.

Job description

About Us

Dianthus Therapeutics is a publicly traded, clinical-stage biotechnology company dedicated to designing and delivering novel, best-in-class monoclonal antibodies with improved selectivity and potency. Based in New York City and Waltham, Mass., Dianthus is comprised of an experienced team of biotech and pharma executives who are leading the development of next-generation antibody complement therapeutics, aiming to deliver transformative medicines for people living with severe autoimmune and inflammatory diseases. To learn more, please visit www.dianthustx.com and follow us on LinkedIn.

About the Role

As the Senior Director, Medical Writing, you will lead the function and play a hands-on role in shaping the communication, development, and delivery of clinical and scientific data to regulatory agencies, healthcare professionals, and other stakeholders.

Reporting to the SVP, Regulatory affairs, this position requires a highly motivated and enthusiastic professional with expertise throughout the product lifecycle. Key success factors for the position include proven track record in overseeing Medical Writing teams and external vendors, and the delivery of high-quality documents (eg, protocols, IBs, CSRs, module 2 summary documents) and publications (abstracts, presentations, journal articles).

This is an exciting opportunity to join a clinical-stage company and build the function while contributing to many milestones as we continue to evolve. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.

Key Responsibilities

Independently author and manage others in creation of clear and concise, submission-ready clinical and regulatory documents
Lead writing strategy, drive document content and organization, establish and manage timelines, and ensure adherence to regulations and guidelines
Oversee document review and comment resolution process
Participate in Rapid Response Teams to support timely delivery of responses to Health Authority Information Requests
Generate and maintain templates, style guides, and quality control checklists that drive consistency
Plan strategically, anticipate problems, and recommend process improvements to address current and future needs
Develop budget and resource strategies to ensure on schedule completion of medical writing deliverables using a mix of internal and external medical writers
Serve on cross-functional teams working on SOPs, process improvements, and integration of new tools and technologies
Coach, develop, and support writers (internal and external)
Act as subject matter expert for development of data transparency deliverables
Oversee medical writing resourcing to support publication plans and ensure consistency of messaging with clinical and regulatory submissions
Ability to travel 10-15% for functional team meetings and company events

Experience

Advanced degree in life sciences preferred; minimum BS/BA required
12+ years’ experience in a medical writing capacity within drug development
Working knowledge of clinical research, study design, pharmacology, biostatistics, regulatory requirements, and medical terminology
Experience leading medical writing teams responsible for global marketing authorization applications
Exceptional information gathering and conceptual skills
Ability to analyze, interpret, and summarize highly complex data
Outstanding project management and organizational skills
Adept at facilitating the open exchange of ideas and opinions to achieve consensus
Ability to work effectively under pressure and meet time-sensitive deadlines
Demonstrated experience mentoring medical writers, managing project work, and supervising internal and external writers
Proficient in the use of MS Word, Endnote, Adobe Acrobat, PleaseReview, and structured document templates
Experience with inspection readiness activities and representing MW during GCP inspections
Proactive team player, collaborative, resourceful, and flexible