Director/Senior Director of Medical Writing en Oruka Therapeutics

Job Title: Director/Senior Director of Medical Writing           

Location: Hybrid – Waltham, MA. Candidates will be required to be in-office 3 days/week.          

Role Overview: 

We are seeking a highly motivated Director/Senior Director of medical writing to join our dynamic, growing team as we work to set a new standard in treating chronic skin diseases. This role will be pivotal to the company as this person will serve as the head of medical writing, responsible for leading and coordinating the writing initiatives on behalf of the company’s two co-lead assets and building the function simultaneously.  This position reports to the Chief Operating Officer.

The ideal candidate will have a strong background in regulatory writing and success functioning in a small company environment as both an individual contributor and a leader.  The candidate should have experience across all phases of drug development and should have the ability to work collaboratively across the R&D organization.  A track record of driving fast paced delivery and seamless management of multiple stakeholder needs is critical. 

Our team values in-person collaboration, and we expect this role to work from our Waltham office at least three days per week. We’re looking for someone who shares our passion for developing innovative medicines and is eager to make a meaningful impact.

Key Responsibilities: 

• Serve as the medical writing subject matter expert on strategic project teams, advising on content, format, and style requirements for documents
• Manage vendors and contractors, providing guidance on prioritization, timelines, and process management.
• Develop and implement a document strategy for clinical and regulatory documents including the writing, editing and/or reviewing of protocol synopses, protocols, investigator brochures, clinical study reports, IND sections, eCTD/BLA clinical summaries and briefing books.
• Collaborate with contributors and reviewers to manage expectations, resolve issues, and ensure alignment on document timelines and content.
• Lead the development and refinement of medical writing processes, SOPs, templates, and quality control measures to ensure efficient preparation of deliverables.
• Drive and execute writing strategies across clinical development program(s) ensuring effective collaborations with other functional areas.

Qualifications:

Experience: 10+ years work experience a medical writer in the biotechnology/pharmaceutical industry

Education: BS, MS, or doctorate in a scientific or medical field

Skills:

• Proven ability to write and edit complex material for clarity, accuracy, and consistency
• Experience managing complex clinical-regulatory writing projects across multiple indications
• Ability to critically analyze and synthesize complex scientific information
• Proficiency in MS Office applications, Adobe Acrobat, and electronic document management systems (e.g. Veeva Vault, Sharepoint)

• Deep understanding of the key requirements for regulatory submissions as stipulated in FDA and ICH guidelines for preparation of INDs, BLAs and MAAs.
• Proven ability to develop and implement medical writing processes and standards
• Strong communication skills with the ability to simply summarize complex information verbally and in written format as well as successfully lead cross functional meetings and reviews

Attributes:

• Self-motivated, action-oriented, and highly organized
• Must feel comfortable working independently with minimal direction in a fast-paced environment with minimal administrative support
• Adaptable to changing priorities and able to manage multiple projects simultaneously
• Strategic thinking and leadership skills

• Operate with integrity, focus, and clarity

Preferred Experience:

• Knowledge of dermatology or rheumatology
• Experience working in a pre-revenue company with limited resources and fast timelines
• Advanced degree

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates, who will work in Waltham, MA, is $205,000 to $275,00. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.